ZAMBIA CONSOLIDATED GUIDELINES

for Treatment and Prevention of HIV Infection

2020

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

 Republic of Zambia
Ministry of Health

Zambia Consolidated Guidelines

for Treatment and Prevention of HIV Infection

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection
TABLE OF CONTENTS
LIST OF FIGURES ............................................................................................................................................................ i
LIST OF TABLES ............................................................................................................................................................ ii
ACRONYMS.................................................................................................................................................................... iii
FOREWORD .................................................................................................................................................................... v
ACKNOWLEDGMENTS ................................................................................................................................................. vi
INTRODUCTION .............................................................................................................................................................. 1
HIV TESTING SERVICES ................................................................................................................................................ 2
PREVENTION ................................................................................................................................................................ 15
MANAGEMENTOFHIV EXPOSED INFANTS ANDHIV INFECTED POPULATIONS ................................................... 29
ART ADHERENCE ........................................................................................................................................................ 60
CO-MORBIDITIES ......................................................................................................................................................... 64
APPENDIX 1: Dosages of Antiretrovirals for Adults and Adolescents ................................................................. 118
APPENDIX 2: Key Drug-Drug Interaction for ARVs................................................................................................. 121
APPENDIX 3: WHO Toxicity Estimates..................................................................................................................... 123
APPENDIX 4: Co-Trimoxazole Desensitization Protocol For Adolescents And Adults....................................... 124
APPENDIX 5: Positive Health Dignity & Prevention (PHDP) .................................................................................. 125
APPENDIX 6: Renal insufficiency screening algorithm (in the absence of Creatinine test) ............................... 126
APPENDIX 7: Formulae for calculating Creatinine Clearance in different patient populations.......................... 127
GLOSSARY ................................................................................................................................................................. 127

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

LIST OF FIGURES
Figure 1: HIV Self-Testing Algorithm .......................................................................................................................................... 4
Figure 2: Index Testing and Partner Notification ........................................................................................................................ 6
FIgure 3: Index Testing Cascade ................................................................................................................................................. 7
Figure 4: Partner Notification Services Algorithm ...................................................................................................................... 8
Figure 5: HIV Serological Testing Algorithm ............................................................................................................................. 11
Figure 6: Recent Infection Algorithm (RITA) with Viral Load Testing in Routine HIV Testing Services ....................................... 13
Figure 7: PrEP Flow Chart ........................................................................................................................................................ 20
Figure 8: Algorithm for Evaluation and Treatment of possible Non-Occupational HIV Exposure .............................................. 22
Figure 9: The Four Pillars/Prongs of EMTCT ............................................................................................................................. 23
Figure 10: Flow Diagram for HIV Care and Treatment from HIV Testing to ART Initiation ....................................................... 30
Figure 11: Same Day ART Initiation Algorithm in Adults .......................................................................................................... 34
Figure 12: Algorithm for Choosing DTG or EFV-400mg in Patients Initiating ART ...................................................................... 38
Figure 13: Viral Load Monitoring in Patients on ART ................................................................................................................ 43
Figure 14: Viral Load Monitoring in Pregnant and Breastfeeding Women on ART .................................................................... 44
Figure 15: Algorithm for Diagnosing Treatment Failure with Routine Viral Load Monitoring.................................................... 50
Figure 16: Algorithm for Choosing a PI in Second-Line ............................................................................................................. 52
Figure 17: Information Pathways for Patients Needing ATC Services ....................................................................................... 56
Figure 18: Barriers to Adherence ............................................................................................................................................. 62
Figure 19: Process of Enhanced Adherence Counselling (EAC) ................................................................................................. 62
Figure 20: Algorithm for Active Interventions when HIV-Infected Clients are Late and determining their Attrition Status ....... 65
Figure 21: TB Screening Algorithm........................................................................................................................................... 66
Figure 22: Xpert MTB RIF Algorithm ........................................................................................................................................ 73
Figure 23: Algorithm of Sputum Smear plus Priority Patients for Xpert MTB/RIF Testing ......................................................... 74
(for Facilities without Xpert Mtb/Rif Acc) ................................................................................................................................ 74
Figure 24: RR/DR TB Patient Triage Flow Chart ........................................................................................................................ 85
Figure 25: Causal Links between underlying drivers for NCDs, Behavioral Risk Factors, Metabolic/Physiologic Risk Factors and
NCDs ............................................................................................................................................................................... 95
Figure 26: Cervical Cancer Screening Algorithm with VIA ....................................................................................................... 100
Figure 27: Cervical Cancer Screening Algorithm with HPV Testing.......................................................................................... 100
Figure 28: Human Resource Management in the ART Clinic ................................................................................................... 108
Figure 29: HIV Implementation Cascade for the Continuum of Care ...................................................................................... 109
Figure 30: Health Management Information System Data Flow Guideline ............................................................................. 116

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection
LIST OF TABLES
Table 1: Timing of HIV Testing Services for Specific Populations .............................................................................................. 10
Table 2: PrEP Follow-up .......................................................................................................................................................... 19
Table 3: Post Exposure Prophylaxis Recommendations by Risk Category ................................................................................. 21
Table 4: Pre-Pregnancy and Adolescents ................................................................................................................................. 24
Table 5: Infants and Children................................................................................................................................................... 25
Table 6: Simplified Infant Prophylaxis Dosing .......................................................................................................................... 27
Table 7: ARV Prescribers and Corresponding Regimens for ART Initiation................................................................................ 29
Table 8: WHO Clinical Staging of HIV Disease by Specific Populations ...................................................................................... 31
Table 9: Eligibility Criteria for ART Initiation in Children, Adolescents, Pregnant and Breastfeeding Women and Adults .......... 32
Table 10: Pre-initiation Tasks .................................................................................................................................................. 33
Table 11: Preferred First-Line ART and Alternative Regimens by Specific Populations ............................................................. 35
Table 12: Preferred First-Line ART and Alternative Regimens for HIV-2 ................................................................................... 40
Table 13: Efficacy of Antiretroviral Therapy against HIV-2 Infection ........................................................................................ 41
Table 15: Clinical and Laboratory Monitoring for HIV-Infected Pregnant and Breastfeeding Women ....................................... 46
Table 16: Common ART Toxicities and Recommended Substitutes (for all populations)........................................................... 47
Table 17: Recommended Second-Line ART Regimens by Specific Populations ......................................................................... 51
Table 18: Summary of Preferred Second-Line ART Regimens for Adults and Adolescents ........................................................ 51
Table 19: Recommended Second-Line ART Regimens for HIV-2 ............................................................................................... 52
Table 20: Infant and Young Child Feeding Options................................................................................................................... 58
Table 21: Specific BMI-Related ARV Drug Risks........................................................................................................................ 58
Table 22: Reporting for Fluorescence Microscopy (FM) Results ............................................................................................... 69
Table 23: Reporting of Ziehl–Neelsen (ZN) Results .................................................................................................................. 70
Table 24: Interpretation of Results for LPA .............................................................................................................................. 70
Table 25: Interpretation of Results for Culture ........................................................................................................................ 72
Table 26: Properties of First-Line TB Drugs .............................................................................................................................. 76
Table 27: Recommended Regimens ......................................................................................................................................... 76
Table 28: Weight Bands for Dosing of Anti-TB Drugs ............................................................................................................... 78
Table 29: Recommended Doses of Adjuvant Steroid Therapy (Drug of Choice is Prednisolone) ............................................... 79
Table 30: Summary of Sputum Monitoring by Smear in First-Line Treatment .......................................................................... 80
Table 31: HIV-TB Co-infection Case Scenarios and Recommended Management for Susceptible TB ........................................ 81
Table 32: Weight-based DR-TB Drugs in Adults 30 kg ............................................................................................................. 86
Table 33: DR-TB treatment monitoring schedule for conventional DR-TB regimen .................................................................. 88
Figure 25: Causal Links between underlying drivers for NCDs, Behavioral Risk Factors, Metabolic/Physiologic Risk Factors and
NCDs ............................................................................................................................................................................... 95
Table 34: Lifestyle Modifications to Prevent and Manage CVDs Among HIV-Infected Individuals ............................................ 96
Table 35: Dyslipidaemia Screening, Diagnosis, and Initial Management for HIV-Infected Individuals ....................................... 96
Table 36: Hypertension Screening, Diagnosis, and Initial Management for HIV-Infected Individuals ........................................ 97
Table 37: Type 2 Diabetes Mellitus Screening, Diagnosis, and Initial Management for HIV-Infected Individuals ...................... 98
Table 38: Chronic Kidney Disease Screening, Diagnosis, and Initial Management for HIV-Infected Individuals ......................... 99
Table 39: Recommended Tests for HIV Screening and Monitoring for Co-infections and NCDs .............................................. 102
Table 40: Dosage for Isoniazid Preventative Therapy, Co-trimoxazole Prophylaxis, and Combination INH/CTX/Vit B6 Drugs . 104
Table 41: Criteria for Initiating, Discontinuing and Monitoring Co-trimoxazole Preventive Therapy....................................... 105
Table 42: Categorization of Services offered at Delivery Points ............................................................................................. 113

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection
ACRONYMS
3TC Lamivudine FQ Fluoroquinolone

ABC Abacavir H Isoniazid

AIDS Acquired Immunodeficiency Syndrome HHD Isoniazid High Dose

ALT Alanine Aminotransferase HIV Human Immunodeficiency Virus

AFB Acid Fast Bacilli HPV Human Papilloma Virus

ANC Antenatal Care HTS HIV Testing Services

ART Antiretroviral Therapy Km Kanamycin

ARV Antiretroviral Lfx Levofloxacin

AST Aspartate Aminotransferase INH Isoniazid

ATC Advanced Treatment Centre INSTIs Integrase Strand Transfer Inhibitors

ATT Anti-Tuberculosis Treatment IPT Isoniazid Preventive Therapy

ATV Atazanavir IRIS Immune Reconstitution Inflammatory Syndrome

AZT Azidothymidine (Also Known as Zidovudine, or ZDV) L&D Labour and Delivery

Bdq Bedaquiline LEEP Loop Electrosurgical Excision Procedure

BD Twice Daily LPV Lopinavir

BMI Body Mass Index MDR TB Multidrug – Resistant Tuberculosis

ART Antiretroviral Therapy MNCH Maternal, Newborn, and Child Health

CD4 T-Lymphocyte Bearing CD4 Receptor MOH Ministry of Health

CD4 % CD4 Percentage MTCT Mother-to-Child Transmission (of HIV)

CDC Centers for Disease Control and Prevention NAT Nucleic Acid Test

Cfz Clofazimine NNRTI Non-Nucleoside Reverse Transcriptase Inhibitor

CNS Central Nervous System NRTI Nucleoside Reverse Transcriptase Inhibitor

CPT Co-trimoxazole Preventive Therapy NUPN National Unique Patient Number

Cm Capreomycin NVP Nevirapine

CRAG Cryptococcal Antigen OD Once Daily

CrCl Creatinine Clearance OI Opportunistic Infection

CTX Co-trimoxazole Ofx Ofloxacin

Cs Cycloserine PAS Para – Aminosalicyclic Acid

CSF Cerebrospinal Fluid PCP Pneumocystis Pneumonia

d4T Stavudine PCR Polymerase Chain Reaction

DBS Dried Blood Spot PEP Post-Exposure Prophylaxis

Dlm Delemanid PHDP Positive Health Dignity and Prevention

DMPA Depot Medroxyprogesterone Acetate PI Protease Inhibitor

DNA Deoxyribonucleic Acid PLHIV People Living With HIV

DOTS Directly Observed Therapy, Short Course PO Per os (Orally)

DRS Drug Resistance Surveillance PNC Postnatal Care

DR TB Drug Resistant Tuberculosis PrEP Pre-Exposure Prophylaxis

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection
DRV Darunavir R Rifampicin

DST Drug Susceptibility Testing RR Rifampicin Resistance

DTG Dolutegravir -r Ritonavir (Low-Dose)

E Ethambutol RNA Ribonucleic Acid

EFV Efavirenz R Rifampicin

EMTCT Elimination of Mother-to-Child Transmission (of HIV) RAL Raltegravir

EPI Expanded Program for Immunization sd-NVP Single-Dose Nevirapine

ETR Etravirine TAF Tenofovir alafenamide

ETV Entecavir FBC Full Blood Count

FDC Fixed-Dose Combination TAT Toxoplasmosis Antigen Test

FP Family Planning TB Tuberculosis

FTC Emtricitabine TDF Tenofovir Disoproxil Fumarate

GRZ Government of Republic of Zambia UNAIDS Joint United Nations Programme on HIV/ AIDS

Hb Haemoglobin UNICEF United Nations Children’s Fund

HBeAg Hepatitis B E-Antigen VIA Visual Inspection with Acetic Acid

HBsAg Hepatitis B Virus Surface Antigen XDR - TB Extensively Drug – Resistant Tuberculosis

HBV Hepatitis B Virus XTC Lamivudine or Emtricitabine

HCW Healthcare Worker FTC Emtricitabine

Z Pyrazinamide

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection
FOREWORD
Zambia has been making remarkable progress in tackling the HIV epidemic. With more than 1,070,000
People Living with HIV on Antiretroviral therapy, we continue to improve in implementing strategies and
interventions that are inclusive and leave no one behind. The National Health Strategic Plan and the
National AIDS Strategic Framework 2017-2021 have ensured that the AIDS response is comprehensive
and targets all underserved populations.

Despite this, each year, 43000 people are newly infected with HIV and the reduction of new HIV
infections in the past 10 years has been slow. At this point in the HIV response it is imperative that we
accelerate our efforts in closing the tap of new HIV infections. Whilst sustaining achieved goals,
preventing new HIV infections is central to ending the AIDS epidemic and eliminating HIV in the Zambian population

It is along these lines that the 2020 ZAMBIA CONSOLIDATED GUIDELINES for Prevention and Treatment of HIV Infection have
been formulated. These guidelines will foster efforts to reduce new HIV infections and HIV related deaths in Zambia. The
interventions and clinical practice being steered by these guidelines will propel Zambia to HIV Epidemic Control. National efforts will
focus on prevention and treatment interventions that are beneficial to the public at large, cost efficient and provide the most efficacious
solutions.

The Zambian Government through Ministry of Health and its partners will work hard to provide all necessary commodities, drugs,
laboratory consumables and reagents that will guarantee patients the highest quality of care at all levels of health provision. In
addition, we will support implementation of differentiated service delivery in order to ensure retention of patients on ART. Other
models of care with established benefits will be taken to scale in all applicable communities.

The Ministry of Health will continue to adopt better tolerated regimens which will make it easier for patients to remain on ART and
have better outcomes. TafED is one such combination suitable for children, elderly patients and patients with renal insufficiency. The
2020 guidelines have better clarified the use of ARVs in other conditions such as hepatitis and prevention of HIV acquisition (in
PMTCT and PrEP). More Zambians will now be able to access these drugs in the prevention of HIV. Health care providers are
extremely encouraged to promote the prevention of infections and promote non-discriminatory care to Zambians.

These guidelines will continue to be a reference on the best clinical practices in the prevention, treatment and management of HIV
infection in Zambia. All communities are urged to know their HIV epidemic and to own the program responses. Health facility staff
and community health workers must synergise efforts and meet patient expectations.

Honorable Dr. Chitalu Chilufya, MP

Ministry of Health

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection
ACKNOWLEDGEMENTS

The Ministry of Health is proud to update the Zambia Consolidated Guidelines for Treatment and Prevention
of HIV to ensure that our recipients of care have access to the latest and quality HIV care. We have employed
a multi-disciplinary approach involving a wide range of stakeholders in the updating process of these
guidelines. This is not only to safeguard our recipients of care but also to ensure that these guidelines are
sound in all aspects including the technical, ethical, social and health systems domains. To this effect, I
would like to extend my sincere appreciation and thanks to the following organizations and individuals who
have worked tirelessly to achieve this exceptional work. These include but not limited to:

Ministry of Health The Global Fund Procurement &

University Teaching Hospital The World Health Organization Supply Management (USAID |
PSM GHSC)
University of Zambia School of Centre for Infectious Diseases Rese
Medicine arch in Zambia Treatment Advocacy & Literacy Ca
mpaign
United States President’s Clinton Health Access Initiative
Emergency Plan for AIDS Relief United Nations Children’s Fund
Catholic Relief Services – EpiC 3-90
(PEPFAR) University of Maryland
Discover Health
Centres for Disease Control and Pre
vention Elizabeth
Glaser Paediatric AIDS Foundation
United States Agency for
International Development EQUIP Zambia
Jhpiego

Special Thanks to the Editorial Committee:

Ministry of Health Dr. Sally Trollip Copperbelt Provincial Health

Prof. Lloyd Mulenga Dr. Edford Sinkala Office
Dr. Gloria Munthali Dr. Manoj Matthews Dr. Justo Banda
Dr. Tina Chisenga Dr. Owen Ngalamika
Dr. Aaron Shibemba Dr. Francis Mupeta
Dr. Richard Nsakanya Ms. Mukumbi Kabesha
Dr. Priscilla Lumano-Mulenga North-western Province Health
Catholic Relief Services – EpiC 3-90 Office
Dr. Henry Phiri
Dr. Albert Mwango Dr. Jonathan Nchengamwa
Dr. Sivile Suilanji
Mr. John Mutukwa Dr. Bosco Mukanyimi
Southern Provincial Health Office
Dr. Chalilwe Chungu
Mr. Peter Funsani Dr. Linos Mwiinga
Mr. Boyd Mwanashimbala Centres for Disease Dr. Chimika Phiri
Control and Prevention (CDC)
University Teaching Hospitals / Northern Provincial Health Office
University of Dr. Annie Mwila
Dr. Mary Boyd Dr. James Nyirenda
Zambia, School of Medicine
Dr. Chipepo Kankasa Dr. Keith Mweembo
Western Provincial Health Office
Mr. Davies Kampamba Dr. Kebby Musokotwane
Dr. Lisulo Walubita
Dr. Sombo Fwoloshi
Centre
Dr. Aggrey Mweemba Kitwe Central Hospital
for Infectious Diseases Research
Dr. Mwitumwa Mundia in Zambia (CIDRZ) Dr. Abidan Chansa
Dr. Paul M. Zulu Dr. Mwangelwa Mubiana-Mbewe
Arthur Davison Children’s Hospital
Dr. Soka Nyirenda Dr. Mwanza Wa Mwanza
Dr. Sam Miti
Mr. Lameck Chirwa Dr. Michael Herce
Dr. Maurice Mwale Clinton Health Access Initiative
Dr. Mwiya Mwiya Lusaka Province
(CHAI)
Dr. Nyakulira Kandiwo Dr. Khozya Zyambo
Mr. Lubinda Nyambe

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection
Livingstone Central Hospital EQUIP Zambia Zambia Medicines Reguratory
Ms Jean Mukumbuta Dr. Crispin Moyo Authority (ZAMRA)
Mr. Ivin Chibanda Mr. Chilambe Mulubwa
Treatment Advocacy & Literacy
Campain Jhpiego United States Agency for
Mr. Felix Mwanza International Development (USAID)
Ms. Nomsa Simwanza
Dr. George Sinyangwe
Discover Health University of Maryland Dr. Nancy Kasese
Dr. Kalasa Mwanda Dr. Cassidy Claassen Ms. Heidi Obra
Dr. Ernest Mwila Ms. Lina Kampilimba-Mwango Mr. Rabson Zyambo
Dr. Msangwa Sinjani
World Health Organization
Dr. Lottie Hachaambwa
Dr. Lastone Chitembo

Dr. Kennedy Malama

Permanent Secretary – Technical Services
Ministry of Health

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection
INTRODUCTION
In July 2019, the World Health Organization released the policy brief on HIV treatment building up on the July 2018 technical update.
This version of the Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection provides simplified guidance on the
country’s transition plan, the continued approach that positively affects the continuum of HIV care, while adding to innovative
methods that will reduce transmission rates and increase life span for those on treatment. This is all to further accelerate efforts to
meet the ambitious 2020 Fast-Track 90–90–90 treatment target: ensuring that 90% of the people living with HIV know their HIV status;
90% of the people living with HIV who know their HIV status are accessing treatment; and 90% of people living with HIV who are
receiving treatment have suppressed viral load, thereby achieving major reductions in the number of people dying from HIV-related
causes and the reducing the number of newly HIV infected people.

Besides the recommendation to provide lifelong antiretroviral therapy to all HIV infected populations regardless of CD4 cell count and
WHO clinical staging, these guidelines present several recommendations, including Universal routine HIV Testing, counselling and
treatment in all public and private health facilities in Zambia. This approach gives a window to provide prioritized HIV testing and
immediate treatment and care to all of those at substantial risk of HIV acquisition but do not leave out those who never had an HIV
test done recently. Furthermore, individuals who are tested HIV positive will have their sample tested for recency HIV in order to
determine whether they are recently infected or long-term HIV. This will accelerate our strides towards HIV epidemic control.
Additionally, these guidelines provide the use of better and safer antiretroviral agents such as Darunavir-ritonavir (DRV-r) as part of
second line HIV treatment whilst emphasizing the use of newer agents like Dolutegravir (DTG), Tenofovir alafenamide (TAF), and
Efavirenz-400mg (EFV), and how to transition patients who are on the older regimens.

Our 2020 guidelines have also adopted the use of a fixed dose combination of Tenofovir alafenamide, Emtricitabine and Dolutegravir
(TafED) to treat HIV positive children aged 6 years and above, and weighing 25kg or more. In order to manage our patients better,
these guidelines also recommend resistance testing after Enhanced Adherence Counselling (EAC) in those who are unsuppressed.

Importantly, there has been introduction of Darunavir-ritonavir (DRV-r) dosed as 800mg/100mg, as a part of the Second-Line regimen
for adults. These guidelines also highlight the management of patients failing Second-Line ART with third-line ART, who should be
managed at higher-level health facilities called Advanced Treatment Centres (ATCs). All of the recommendations have been adopted
because of their anticipated public health effect.

Several significant recommendations from the previous guidelines remain a priority, namely providing lifelong ART regardless of CD4
cell count and WHO clinical staging, to all populations, and moving toward viral load testing as the preferred means of monitoring
people on ART. Newer developments aim to complement and improve the service delivery of HIV services to our population.
Importantly, in the guidance WHO emphasizes the need for differentiated approaches to care for people who are stable on ART, such
as reducing the frequency of clinic visits and community ART distribution. Such efficiencies are essential if countries with a high
burden of HIV infection are to manage their growing numbers of people receiving ART and reduce the burden on people receiving
treatment and on health facilities.

There will be continued concerted efforts required toward implementing these guidelines at district and health facility levels; the 2020
Consolidated Guidelines represent an important step toward achieving the goal of universal access to ARV drugs, treating and
preventing HIV, and ultimately ending the HIV epidemic by 2030.

1 | Introduction

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

HIV TESTING SERVICES

Recommendations

Universal Routine HIV Testing and Linkage to Services

Targeted HIV Testing through Index Testing (IT) and

Partner Notification Services (PNS)

Use of a screening tool to reduce unnecessary HIV tests

HIV Self-testing for increased access to testing Services

NAT at 9 months in HEI

Recency Testing for HIV Surveillance of incidence of HIV

Infection

HIV testing services include the full range of services that should be provided together with HIV testing which include counselling
(pre-test information and post-test counselling); linkage to appropriate HIV prevention, treatment and care services, and other clinical
and support services; and coordination with laboratory services to support quality assurance and the delivery of correct results.

HTS is primarily conducted by healthcare workers as well as trained, certified and supervised lay providers that can conduct safe and
effective HIV testing using recommended test kits. HTS begins with assessing the risk of HIV infection using the HIV screening
tool.

HTS should be done at all health service delivery points (see

Table 1) within the facility, as well as in the community, as an efficient and effective way to identify people living with HIV (PLHIV),
bearing in mind the priority and key populations. Facility based HTS will largely focus on PITC using the HIV Screening Tool at all
Service Delivery Points. Community-based testing largely centered on Hot Spot Testing and Index testing. Hot Spot Testing is
targeted at particular population or places sharing similar characteristics putting them at risk of HIV acquisition or known to
have high yields of HIV positive tests. Mapping of Hot Spots is based on trends in specific areas and could change (there is
need to revist such mapping every 6 months or as need arises).

HIV Repeat and Re-testing

Repeat Testing – Refers to a situation where additional testing is performed for an individual immediately following a first
test during the same testing visit due to inconclusive or discordant results. This may include a repeat testing using Determine-
Bioline algorithm if client reports positive HIV Self-Test (HIV-ST), or repeat HIV testing if HIV test result is indeterminate or
discordant.

The same assays are used and, where possible, the same specimen.

Re-testing – Refers to a situation where additional testing is performed for an individual after a defined period of time for
explicit reasons, such as; a specific incident of possible HIV exposure within the past three months, or on-going risk of HIV
exposure such as HIV negative persons with HIV-positive partner, sharing injecting equipment or having sex with a person
of unknown status, or indeed re-test if on PrEP.

Re-testing is always performed on a new specimen and may or may not use the same assays (tests) as the one at the initial
test visit.

2 | HIV Testing Services

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

U N I V E R S A L R OU T I N E HIV T E S T I NG
Universal Routine HIV Testing Services is a policy statement by the Zambian Government that directs the offering of HTS at all
health facilities, including all public and private health facilities (Universal) and always or whenever health services are provided
(Routine). It is an opportunity to screen all clients to determine HIV risk using the HIV Screening tool and provide immediate
treatment and care to all HIV infected individuals through the “test and treat” strategy without using CD4 or WHO clinical staging
as an eligibility criterion for HIV treatment.

Healthcare workers are therefore obliged to always offer HIV testing services to all individuals presenting to health facilities
through the various entry points such as inpatient and outpatient departments, Children’s malnutrition units, STI clinics, TB clinics,
maternal and child health, community services and others. HTS services should also be offered to the caregivers and other family
members. Universal routine HIV testing services should be offered with the following considerations:

1. Provide information in a confidential manner - those who opt out should continue to be counselled and offered an HIV
test at each interaction with healthcare providers, including the opportunity to self-test.
2. Administer the HIV Screening tool to determine eligibility for an HIV test
3. If eligible, provide counselling on the benefits of HIV testing and other services available for HIV negative and positive
individuals
4. Provide correct results following the HIV testing algorithms
5. Elicit contacts (sexual and biological children, and needle sharing partners) for the HIV Positive individuals for index testing
purposes
6. Provide linkage or connection to preventive and treatment and care services by issuance of a National Unique Patient
Identification Number (NUPIN), regardless of the test result

National HIV Testing Screening Tool

The National HIV testing Screening Tool is an algorithm with a set of questions that help to prevent unneccesary repeat HIV tests to
avoid wastage of HIV test kits. The Screening Tool will must exclude all individuals known to be HIV positives from repeat HIV tests.
It must also identify individuals at high risk of being HIV infected and subsequently will need to have an HIV test done. The following
are the elements of an HIV test screening tool.

Elements of an HIV Screening Tool for adults

1. Determing Testing History : All Known HIV positive individuals should not have a repeat HIV test but must be linked to care
and advised to be adherent to treatment and ensure they are virologically Suppressed, All Key populations (Individuals with
high risk acquisition ) must have an HIV test every months and all other individuals must have an HIV test every 12 months.
2. Screening for symptoms suggestive of HIV
3. Screening for high risk HIV exposure: A symptomatic screening for HIV associated illnesses and STIs, and a screening for
recent HIV exposure sexually or through body fluid contacts must be used to determine who will need an HIV testing. ALL
indivifuals with symptoms suggesting of HIV or recent probable exposure to HIV must be tested for HIV
4. ALL pregnant and brestfeeding women must receive an HIV test every 3 months irregardless of risk or exposure

Elements of an HIV Screening Tool for Children

1. Testing History: All known HIV positive children should NOT be tested for HIV again
2. HIV negative children with a documented result with no known HIV risk should NOT have an HIV test done
3. All children who have never had HIV test before and have risk for HIV acquisition must have an HIV test. Risk for HIV in
children include: children whose biological mother is HIVpositive, HIV status unknown both Parents are deceased, or has
history of sexual assault or exposure to HIV infected body fluids
4. An age appropriate HIV test must be done for children

A Clinician can override the HIV Screening Tool based on clinical presentation of the patient

3 | HIV Testing Services

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

HIV S E L F -T E S T I NG (HIV-ST)
HIV-ST is a process in which a person collects their own oral fluid or blood and then performs an HIV rapid test and interprets the result
- often in a private setting either alone or with someone he or she trusts. It is targeted particularly among populations at ongoing high risk
of HIV acquisition, who may be less likely to access testing or test less frequently, eg men, adolescents, Key Populations and Sero-
discondant couples. The test can be Assisted or Unassissted HIV-ST.

Assisted HIV-ST refers to trained providers or peers giving individuals a personal demonstration before or during HIV-ST on how to
perform the test and interpret the results.
Unasssisted HIV-ST refers to when individuals self-test for HIV and only use an HIV-ST kit with manufacturer-provided instructions for
use.

An HIV self-test is a screening test, which requires further testing and confirmation for any reactive result. Healthcare providers should
ensure that users receive clear information on:

1. How to perform the test and interpret the result correctly

2. Where to access HTS and further support services
3. How to safely dispose off the used test-kits
4. The ethical and legal obligations (no one should test a third party without their consent)
HIV-ST is not to be used as a Pre-entry to a Determine test. It should not be used as a screening test either in the community or at the
facility for the purpose of either to increase the positive tests yields or to identify those who require a determine test, Healthcare providers
should never use the self test as a replacement for the Determine when not available.
The use of HIV-ST in known HIV Positive individuals is not rercommended.

Monitoring and Programming of HIV Self-Test

The monitoring of the effectiveness of the self-testing program is by assessing the number of HIV Self-Test kits that have been
distributed to the individuals since the HIV Self-Test is meant to be an opportunity for individuals to know their HIV status.

F I G U R E 1: HIV S E L F -T E S T I N G A L G O R I T H M

HIV Self-Testing
(Assisted or Unassisted)

If Non-reactive/Negative:
If Reactive/Positive:
If there was possible exposure to HIV in the
Confirm result at clinic with trained provider preceding 6 weeks or with ongoing risk of
using validated algorithm. HIV infection, repeat test after 3 months.

Recommend comprehensive
prevention services.

If confirmed HIV-positive: Recommend comprehensive

prevention services
Refer for treatment

4 | HIV Testing Services

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Index Testing and Partner Notification Services

Index Testing is a focused HTS approach in which contacts (sexual networks, needle sharing partners and biological
children, less than 15 years of age) who have been exposed to HIV infection are offered HIV Testing. An index is identified
as a newly diagnosed HIV positive client or a PLWHIV who has been identified with a high viral load. Contacts are elicited
from the index who could be a sexual partner, biological children from the female clients and needle or blade sharing
individuals.

The process starts with the Index clients sharing information on their partners, if the client is female, all biological children
under the age of 15. Contacts are then followed up and informed of their HIV exposure and offered HIV testing services.
Those who test positive are immediately linked to care and they become new Index clients who will give information on their
sexual partners. If female, biological children under the age of 15, needle or blade sharing partners, are elicited and the
process starts all over again.

All HTS in this setting is done with a serological test, also known as antibody test, and HIV negative clients are offered a re-
test after 3 months to account for the window period. Beyond the window period, they should be offered the test according
to National Guidelines.

HIV Partner Notification Services (PNS)

HIV Partner Notification is a voluntary process where trained healthcare providers (including lay providers) ask index clients (people
diagnosed with HIV) about their sexual or drug injecting partners, and with their consent to offer HIV testing to these partners who
may have been exposed to HIV preferably within the past 12 months.

Partner notification is provided using passive or assisted approaches. (It is recommended to use the best approach for each index
client at that time).

Passive HIV partner notification services is where HIV-positive clients are encouraged by healthcare workers to disclose their status
to their sexual/drug injecting partners by themselves, and to suggest HTS to the partner(s) given their potential exposure to HIV
infection. Being at the discretion of the index client to encourage their contacts to test, this approach is less effective.

Assisted HIV partner notification services is where consenting HIV-positive clients are assisted by healthcare providers to disclose
their status or to anonymously notify their sexual/drug injecting partner(s) of their potential exposure to HIV infection. The provider
then offers testing to these partner(s).

Assisted partner notification is done using provider contract or dual referral approaches.

Provider contract is where HIV-positive clients enter into a contract with a trained provider and agree to disclose their status (and the
potential HIV exposure to their partners) by themselves and to refer their partner(s) to HTS within a specific time period. If the
partner(s) of the HIV-positive individual do not access HTS or contact the healthcare provider within 14 days, then the trained provider
will contact the partner(s) directly and offer voluntary HTS.

Provider referral is when the healthcare provider confidentially contacts the person’s partner(s) directly and offers the partner(s)
voluntary HTS.

Dual referral is when a healthcare provider accompanies and provides support to HIV-positive clients when they disclose their status
and the potential exposure to HIV infection to their partner(s). The trained provider also offers HTS to the partner(s).

In partner and family-based index testing, it is critically important to ensure that sexual partners and children under the age of 15
years are also offered an opportunity to test for HIV.

Assessment for Intimate Partner Violence should be conducted during index testing and PMTCT/ART visits to avert Gender Based
Violence. Where it occurs, it should be properly documented in the appropriate data collecting tools.

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

How to assess for Intimate Partner Violence

The first duty as healthcare providers is to do no harm. To protect the safety of the index client, partners who pose a risk of Intimate
Partner Violence (IPV) may need to be excluded from Partner Notification Services.

Each named partner should be screened for IPV using the 3 screening questions which include:

1. Has [partner’s name] ever hit, kicked, slapped, or otherwise physically hurt you?
2. Has [partner’s name] ever threatened to hurt you?
3. Has [partner’s name] ever forced you to do something sexually that made you feel uncomfortable?

F I G U R E 2: I N D E X T E S T I N G AND PARTNER NOTIFICATION

Step 1:
Introduce Index Testing Services to the Index Client during pre-test
session or PMTCT/ART visit

Step 2:
Obtain a list of sex and needle-sharing partners and biological children < 15 years with
unknown HIV status

Step 3:
Conduct an Intimate Partner Violence (IPV) risk assessment for each
named partner

Step 4:
Determine the preferred method of partner notification or child testing for each
named partner/child

Step5:
Contact all named partners and biological children < 15 years with
unknown status using preferred approach

Step 6:
Record outcomes of partner notification and family
testing

Step 7:
Provide appropriate services for children and partner(s) based on HIV
status

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Monitoring and Programing of Index Testing

The Index Testing Cascade is used to monitor the extent (scalability) and quality (fidelity) of the implementation of Index
Testing. Figure 3 below shows the Index Testing Cascade:

FI G U R E 3: I N D E X T E S T I N G C A S C A D E

The following indicators could be measured from the Index Testing Cascade:

• Number of index clients offered index testing services

• Number of index clients who accept index testing services
• Number of partners/children listed by index clients
• Number of partners successfully contacted
• Number of partners/children known HIV-positive at the time of contact
• Number of partners/children diagnosed with HIV
• Number of HIV-positive partners/children linked to HIV treatment
• Number of HIV-negative partners linked to prevention (condoms, PrEP, VMMC)

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

F I G U R E 4: P A R T N E R N O T I F I C A T I O N S E R V I C E S A L G O R I T H M

Engaging the Index Client

Step 1: Introduce Partner Notification Step 2: Obtain a list of all partners who Step 3: For each listed partner, record
Services to the Index Client and may be at risk for HIV infection contact information, screen for intimate
obtain concurrence partner violence (IPV), and determine the
preferred notification method

Notifying the Partner(s)

Step 4: Contact each named partner Step 5: Record outcomes on Partner

using the selected approach; notify Notification Worksheet Step 6: Record all data in PNS Register
and offer HTS

Client self-Referral: Coach client on

disclosure; provide “Tips for Telling Your
Partner about HIV” and referral

Provider Contract Referral: Coach

client on disclosure; provide “Tips for
Telling Your Partner about HIV” and
referral slip. Agree that client will refer
partner for HTS within 30 days

Provider Referral: Initiate partner

contact attempts using telephone, SMS,
and home visit scripts.

Dual Referral: Coach client on joint

disclosure process and develop plan for
provider and client to disclose to partner
together; provider offers HTS to partner.

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

E A R L Y I N F A N T D I AGNOS I S

For children <24 months old who are breastfeeding, the mother should be tested first. If she is HIV-positive, perform a Nucleic Acid
Test (NAT) which can be done on the HIV-exposed infant (HEI), regardless of age. NAT can be performed on either a Dried Blood
Spot (DBS) which is sent to the laboratory or fresh blood sample using a Point-of-care machine (POC). The advantage of POC
technologies is that they are available at the point of service delivery and offer same-day results. Infants who have HIV detectable by
NAT at birth are likely to have been infected in-utero. These infants will progress to disease rapidly, and, in the absence of treatment,
will experience high mortality in the first few months of life. Infants infected at or around delivery may not have t h e virus detectable
by NAT for several days to weeks. The ability of NAT to detect the virus in the blood may be affected by ARV drugs taken by the
mother or infant for postnatal prophylaxis, resulting in false-negative results. This includes drugs present in breast milk as a result of
maternal ART during breastfeeding.

The rationale behind this recommendation is that infants who are first identified as HIV-exposed postpartum have a high cumulative
risk of already having acquired HIV by the time prophylaxis is initiated; thus, NAT should be performed around the time of initiating
prophylaxis, which would be at birth. This will help to minimize the risk of development of resistance because of extended prophylaxis
in infected infants and help to promote linkage to timely initiation of ART.

L I NKAGE T O HIV T R E A T ME N T A N D S U P P OR T S E RV I CE S
Linkage to care is a process of actions and activities that support people testing for HIV and those diagnosed with HIV to engage with
prevention, treatment, and care services as appropriate for their HIV status. Linkage to care and treatment is the period beginning
with HIV diagnosis and ends with a person being initiated on ART.

For clients who test HIV negative, it is necessary to link them to prevention services including condoms, VMMC, PrEP, and others
depending on their individual risk factors. Linkage to treatment is a vital bridge between diagnosis and treatment initiation. All identified
positives should be linked to care, treatment and supportive services

Q U A L I T Y A S S URANCE /I MP R OV E ME N T

Quality Assurance:

Overview: Quality Assurance for HIV testing

Quality assurance (QA) is a part of quality management focused on providing confidence that quality requirements will be fulfilled.
Quality assurance implemented through quality management systems is essential for any testing service, ranging from HIV testing
conducted in laboratories and health facilities to community-based settings, including rapid diagnostic tests (RDTs) performed by lay
providers.

QUALITY ASSURANCE is an ongoing set of activities that help to ensure that the T E S T results provided are as accurate and reliable
as possible for all persons being T E S T E D . It is the ethical responsibility of all people conducting HIV testing (including lay providers)
and all programmes or facilities offering HTS to conduct testing according to quality management system principles to ensure the
highest level of quality and accuracy.

Important Note:

• All testing sites should participate in HIV proficiency testing at least twice per year. For all people conducting HIV testing,
including lay providers, every 10th sample (10%) should be sent for External Quality Assurance test at the nearest laboratory. All
providers conducting HIV tests should be certified to ensure competence and quality in the services rendered
• All HIV-2 or HIV-1 & 2 positive results tested by Community Based Volunteers (CBVs) should be repeated by a professional
laboratory staff
• All HIV positives tested by Community Based Volunteers (at community and facility level) should be repeated by a
professional lab personnel or other HCW (in the nearest facility) before ART initiation

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

 T A B L E 1: T I M I N G OF HIV T E S T I N G S E R V I C E S FOR SPECIFIC POPULATIONS

Specific populations Whom to test When to test HIV testing

During antenatal care (ANC): at first
ANC visit and retest every 3 months if
negative

In labour and delivery (L&D): test if

last test >6 weeks ago
Pregnant women,
breastfeeding During postnatal care (PNC): test at
women (and their All first contact if unknown status. Serological test
sexual partners) Serological test at 6 weeks if negative.

If breastfeeding: retest every 3

months if negative until cessation of
breastfeeding

Partner testing: same time points

At birth/first week of life or at first

Well, never-breastfed HIV contact NAT*
Exposed Infant (HEI) 6 weeks old
24 months old Serological test

At birth/first week of life or at first

contact
NAT*
6 weeks old
6 months old
9 months old NAT

Well, breastfed HEI Serological test, if positive, follow up with

(0 to <10 years old) NAT. If negative, follow up with serological
12 months old
test at 18 months
Serological test; if positive, follow up with
s 18 months old NAT. If negative, follow up with serological
a test at 24 months
d
Serological test; if positive, follow up with
24 months old
s NAT
f or child who has
Infant ≥6 weeks after breastfeeding Serological test; if positive, follow up with
d
completely stopped cessation in children <24months old NAT
breastfeeding
s
>24 months old Serological test
f
s Maternal serological test and/or infant
Asymptomatic infant with
At first contact serological test; follow up with NAT for
unknown HIV exposure
positive serological child ≤24 months old

Infant or child symptomatic for Serological test; follow up with NAT for
Immediately regardless of age positive serological child ≤24 months old
HIV infection

Positive serological child

<24 months old At first contact NAT

All infants and children with

unknown HIV status admitted Administer Paediatric Screening Tool
for inpatient care, attending and test appropriately Age-appropriate tests
malnutrition clinic, outpatient
care or immunization clinics

Administer the HIV Screening Tool at

Adolescents (10 – 19 All sexually active persons
first contact, if negative repeat test at 3
with their partners and any Serological test
years) and adults months and appropriate intervals
person of unknown HIV status
depending on risk assessment

* Where there is no POC NAT a DBS should be sent for HIV DNA PCR. Where NAT is positive, a repeat test should be done to rule out false-positive results. ART should
be initiated without waiting for the receipt of the second test result because of the high risk of mortality with in utero infection; if the second specimen tests negative, a third
NAT should be performed before interrupting ART. Although plasma remains the gold standard sample for NAT, DBS will be the preferred mode of sample transportation for
both DNA and RNA testing
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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

F I G U R E 5: HIV S E R O L O G I C A L T E S T I N G A L G O R I T H M

Self -Testing

Universal Routine Testing (Screening Test) by

healthcare provider. If Self-Testing results are
Test-1 Reactive

Results – Reactive. Proceed to test 2 Results – Non-reactive

Confirmatory and HIV-2 differentiation Report as HIV negative

Test 2 – Reactive
Report as HIV Positive Test 2 – Non-reactive

All those tested HIV

positive should be index
cases for Index Testing Repeat Testing using the same
HIV 1 HIV 2
specimen (Test 1 & 2)

Both tests 1 & 2 Both tests 1 & 2 Discordant results

are reactive are Non-reactive Re-test after 14 days
Report as Positive Report as Negative Using same tests

• HIV testing for those ≤24 months, NAT is gold standard. Although plasma remains the gold standard sample for NAT, DBS will be the
preferred mode of sample transportation for both DNA and RNA testing
• Index patient refers to the client being tested and identified HIV positive, whether child, adolescent or adult
• Determine is used as a screening test and Bioline as confirmatory test (discriminates between HIV-1 and HIV-2)
• If discordant result and POC available, you may perform a NAT

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

R A P I D T E S T F OR R E CE NT I N F E C T I ON

Background
HIV Epidemic Control is defined as limiting the annual number of new HIV infections in a country to less than the number of deaths
among people living with HIV. As the national HIV program is implementing interventions to reduce new HIV infections, there is a
need to also quickly and easily track and distinguish a recent HIV infection (acquired within the last 12 months) from a long-term
infection. This information with other surveillance data can be used to estimate national and sub-national HIV incidence.

What Recency Testing is

This is HIV testing that can diagnose HIV infection and distinguish recent from long-term infection. These tests can be performed
using a laboratory-based test (which takes several days to get a result) or the newer Rapid Test Recency Infection (RTRI) tests.
These tests only work for HIV-1 infection and work on the same principle of using limiting antigen to distinguish recent or long-term
HIV infections. However, with RTRI results can be available within 20 minutes. RTRI have been evaluated and can characterize
recent HIV infection as having been acquired within the past 12 months.

Purpose of Recency Testing

Recently (or newly acquired) HIV infections frequently characteristically result in infected persons having high viral loads, immature,
and weak immune responses. These individuals commonly have continued high risk behaviour and on-going transmission. This
strategy will help identify new clusters of transmissions, inform and maximize the efficiency of testing contacts, reach communities
and networks eluding notice now, and provide useful information to clients that can help them to be better involved in their care.

There are interventions that can interrupt transmission, which include index testing with successful contact tracing (as contacts are
recent) and targeted testing based in regions or catchments were on-going transmission can be mapped. Provision of intensified HTS
and same day ART (SDART) services can quickly curb new infections.

How will Recency Testing be done

Recency testing will be performed on patients whose HIV tests are positive using the routine HIV testing algorithm. To avoid false
recent results, a recent infection testing algorithm with viral load testing is used. This algorithm combines laboratory tests and clinical
information to correct classify an HIV infection as recent or long-term. Patients who are on ART, elite controllers, those infected with
HIV-2 or certain subtypes (e.g. clade D) may show a false positive recency test result. To control for these a clear clinical and lab
history can assist in avoiding these errors.

Persons who test recent on the RTRI should have a blood specimen tested for viral load. Those who test recent on the RTRI and
have a viral load ≥1,000 copies/mL are considered as a confirmed recent case.

In Zambia, HIV Recency testing has been introduced using an antibody test (Asente) on a surveillance basis while awaiting rapid
tests for clinical use.

Key:
LT – Long term line; R – Reactive; Neg – Negative; C – Control line; V – Verification line

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F I G U R E 6: R E C E N T I N F E C T I O N A L G O R I T H M (RITA) WITH VIRAL LOAD TESTING IN R O U T I N E HIV T E S T I N G
SERVICES

HTS Client Zambia HIV Testing

Algorithm
Determine

Report NEGATIVE Non-Reactive Reactive

Bioline Routine Case finding

strategies

INDETERMINATE National Surveillance

Non-Reactive HIV-Positive Report POSITIVE
(follow Guidelines) system

National M & E
system
Supplementary Test for Recent Test for recent Infection of
Infection among newly diagnosed New Diagnosis

Tested Tested
recent Long term

Viral Load test

Confirmed recent Report RECENT

(Tested recent + VL ≥1,000 copies/mL)

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Summary/Key Points

• HIV testing services (HTS) include HIV testing, pre-test information, post-test counselling, linkage to appropriate HIV
prevention, treatment, care, other clinical services, and coordination with laboratory services to support quality assurance
(QA) and delivery of accurate results
• HTS should be done at all service delivery points within the facility, as well as in the community, as an efficient and effective
way to identify people with HIV
• HIV testing is the gateway to HIV prevention, treatment, care, and other support and clinical services, and Universal HIV
Testing, Counselling and Treatment (HTCT) should be offered to all clients and in all service points
• HIV testing is primarily conducted by healthcare workers. Lay providers who are trained, certified by MOH, and supervised
can conduct safe and effective HIV testing using recommended diagnostic tests
• All mothers of breastfeeding children ≤ 24 months old should be tested every 3 months. If she tests HIV positive, a Nucleic
Acid Test (NAT) should be performed on the HIV-exposed infant (HEI). Where NAT is positive, a confirmatory NAT test
should be done to rule out false-positive results
• ART should be initiated without waiting for the receipt of the second test result because of the high risk of mortality with in-
utero infection; if the second specimen tests negative, a third NAT should be performed before interrupting ART
• Where NAT is negative in a never breastfed HEI, a repeat test should be done at 6 weeks
• Where NAT is negative and HEI is still breastfeeding, NAT retest should be done at 6 weeks, 6 months, and 9 months then
do serological test at 12 months, 18 and 24 months
• Community-based testing embraces Index Testing and Hot Spot Testing, where index-patient leads to early diagnosis of
HIV infection and prompt linkage to care and treatment
• Recency Testing will help identify new clusters of transmissions, inform and maximize the efficiency of testing contacts and
fast track immediate ART

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

PREVENTION

Recommendations

PrEP to be used as preventive measure of HIV transmission

in people at substantial risk of HIV acquisition

ARVs used for oral PrEP and PEP

Adherence and treatment support for those on PrEP

Offer PrEP to all HIV negative PBFW in serodiscordant

relationships or at substatntial risk of HIV acquisition

P R E -E X P OS URE P R OP H Y L A X I S (P R EP)

Pre-exposure prophylaxis, or PrEP, is when people at high risk for HIV take two HIV medicines daily to lower chances of getting
infected. When someone is exposed to HIV through sex or injection drug use, these medicines can work to keep the virus from
establishing a permanent infection.

PrEP involves the use of antiretroviral (ARV) drugs before HIV exposure by people who are not infected with HIV to block the
acquisition of HIV. Twelve trials on the effectiveness of oral PrEP have been conducted among serodiscordant couples, heterosexual
men, women, men who have sex with men, people who inject drugs, transgender men and women. Where adherence has been high,
significant levels of efficacy have been achieved, showing the value of this intervention as part of combination prevention approaches.
Oral PrEP containing Tenofovir disoproxil fumarate (TDF) or alternatively Tenofovir alafenamide (TAF) with either Emtricitabine (FTC)
or Lamivudine (3TC) should be offered as an additional prevention choice for people at substantial risk of HIV acquisition as part of
combination HIV prevention approaches.

Considerations for PrEP

• The combination of TDF or TAF+XTC (Emtricitabine or Lamivudine) is active against Hepatitis B infection thus
discontinuation of TDF+XTC requires close monitoring in those infected with Hepatitis B due to the concern for rebound
viremia
• In case of renal insufficiency, with CrCl between 30 – 50 mL/min, TAF+FTC can be used. However, note that TAF use is
not currently recommended for use in patients on Rifampicin-based TB treatment or pregnant women
• Persons with osteopenia/osteomalacia/osteoporosis may be at risk of bone loss associated with TDF therefore TAF would
be recommended in such populations
• TDF should not be co-administered with other nephrotoxic drugs, e.g. aminoglycosides
• Standard TB medication does not interact with PrEP drugs and there is no need for dose adjustments
• Standard hormonal contraception does not affect PrEP effectiveness, nor does PrEP affect contraceptive effectiveness
• PrEP clients must be routinely tested for HIV infection, and ART offered immediately if the PrEP user seroconverts
• PrEP alone is not 100% effective at preventing HIV and clients need to be counselled that they should use other prevention
methods as well

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

PrEP considerations for Pregnant and Breastfeeding Women

Pregnant and breastfeeding women, often remain at substantial and increased risk of HIV acquisition during pregnancy and
breastfeeding. Biological factors increase susceptibility, and social and behavioural factors may increase exposure to HIV infection.
Pregnant and breastfeeding women who acquire HIV at this time have a greater risk of transmitting HIV to their infant than women
who became infected with HIV before pregnancy.

There is no safety-related rationale for disallowing or discontinuing PrEP use during pregnancy and breastfeeding for HIV-negative
women who are receiving PrEP and remain at risk of HIV acquisition. The guidelines conclude that in such situations the benefits of
preventing HIV acquisition in the mother, and the accompanying reduced risk of mother-to-child HIV transmission outweigh any
potential risks of PrEP, including any risks of fetal and infant exposure to TDF and XTC in PrEP regimens. Active toxicity surveillance
for ARV use during pregnancy and breastfeeding is highly recommended though.

Although there is limited experience with the use of PrEP in antenatal and postnatal care services, it is an important new HIV
prevention method.

Indications for PrEP in Pregnant and Breastfeeding Women

• A woman taking PrEP who subsequently becomes pregnant and remains at substantial risk of HIV infection
• A pregnant or breastfeeding HIV-negative woman who is or perceives herself to be at substantial risk of HIV acquisition
• A pregnant or breastfeeding HIV-negative woman whose partner is HIV-positive
• An HIV- negative woman who is trying to conceive if her partner is HIV- positive

In such cases, PrEP combined with screening for acute infection, adherence counselling, safety monitoring and HIV retesting every
three months, in addition to other existing HIV prevention options, including condoms, should be offered.

Key messages

1. PrEP is safe during pregnancy and breastfeeding: The ARVs used for PrEP, TDF+XTC, are frequently used in
combination with other ARVs for HIV treatment and are safe in this population.

2. TAF+FTC can be used in patients with CrCl between 30 and 50mL/min, though TAF is not currently recommended for use
in patients with TB or pregnancy.

3. PrEP should be provided as part of a comprehensive package: PrEP is part of a package of combination HIV
prevention and other services that includes HIV testing services, assisted partner notification, provision of male and female
condoms and lubricants, contraception choices and screening and treatment of STIs.

4. Adherence matters: Women have to understand the benefits of PrEP and will benefit from advice and support.
Adolescents may need special support for adherence.

5. Disclosure can have benefits: Some women may find disclosure of their PrEP use to their partners helpful in supporting
their own adherence.

6. Recognize “seasons of risk”: A woman’s risk may vary over time as circumstances change. Women should be supported
to start and to stop PrEP if their HIV risk changes. Risk for HIV acquisition is not constant.

7. Hormonal contraception: PrEP can be used with hormonal contraception. Recommended PrEP regimens do not appear
to alter the effectiveness of hormonal contraception.

8. PrEP in not for everyone: It is a choice, and women should be making an informed decision based on their risk for HIV.
All women should be counseled on the range of HIV prevention modalities that they can choose from to minimize the risk
of HIV acquisition during pregnancy.

9. Ongoing surveillance is necessary: Active surveillance of pregnant and breastfeeding women receiving PrEP is needed
to identify and record adverse pregnancy and infant outcomes. Clients on PrEP need to be followed up at the clinic for
routine monitoring.

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Eligibility Criteria
• No suspicion of acute HIV infection
• Test HIV negative at health facility
• Perceives to be at substantial risk of HIV acquisition and willing to be adherent
• Able to attend regular 3-months reviews and HIV testing
• Able to concomitantly apply other prevention methods such as barriers to prevent the transmission of other STIs
• Willing to stop taking PrEP when no longer eligible

And: at substantial risk for HIV infection, defined as engaging in one or more of the following activities within the last six months:
• Vaginal/anal intercourse without condoms with more than one partner
• Sexually active with a partner who is known to be HIV positive or at substantial risk of being HIV positive
• Sexually active with an HIV-positive partner who is not on effective treatment (defined as on ART for < 6 months or not virally
suppressed)
• History of STI
• History of PEP use
• Sharing injection material or equipment

Acute HIV Infection (AHI)

Acute HIV infection (AHI) is the early phase of HIV disease that is characterized by an initial burst of viremia. AHI infection develops
within two to four weeks after someone is infected with HIV. Approximately 40% to 90% of patients with AHI will experience “flu-like”
symptoms. These symptoms are not specific to HIV, they occur in many other viral infections. Remember that some patients with
AHI can be asymptomatic. Do NOT start PrEP in clients with suspected AHI.

An estimated 40-90% of patients with acute HIV infection will experience ‘flu-like” symptoms which usually appear days to weeks
after exposure and include:
• Fever
• Fatigue
• Anorexia
• Rash (often erythematous maculopapular)
• Pharyngitis
• Generalized lymphadenopathy
• Mucocutaneous ulceration
• Headache
• Aseptic meningitis
• Radiculitis, myelitis
• May present with OIs, thrush, herpes zoster (if CD4 depressed)

These symptoms are not specific to HIV; they occur in many other viral infections. Remember that some patients with acute HIV
infection will be asymptomatic.

Diagnosis of AHI
• During AHI, antibodies might be absent or be below the level of detection
• Serological testing using rapid test might be negative
• AHI can be diagnosed using “direct” viral tests like HIV RNA or HIV antigen testing
• In the absence of HIV RNA and antigen testing, PrEP should be deferred for four weeks if AHI is suspected
• Repeat HIV serological test after four weeks to reassess eligibility

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

SUBTANTIAL RISK FOR HIV INFECTION (based on history in the past 6 months)
§ Clients who is sexually active in a hihgh prevalence population (either in the general population or key population group)
and reports any of the following in the past six months:
o Vaginal or anal intercourse without condoms with more than one partner, or
o Sexually active with a partmer who is known to be HIV positive or at substantial risk of being HIV positive, or
o History of an STI (based on lab test, syndromic STI treatment, self-report), or
o History of use of Post-Exposure Prophylaxis (PEP), or
o Client who reports history of sharing of injection material/equipment with another person in the past six months, or
o Client who reports having a sexual partner in the past six months (on ART for less than 6 months or has inconsistent
or unknown adherence) who is HIV positive and who has not been on effective HIV treatment.

SCREENING FOR SUBSTANTIAL RISK

• Screening questions should be framed in terms of people’s behavior rather than their sexual identity and should refer to a
defined time period (6 months, etc.)
• It is important for PrEP providers to be sensitive, inclusive, non-judgmental, and supportive
• Be careful not to develop a screening process that might discourage PrEP use

PrEP may also be considered for key populations (as defined by the 2017 NASF) or by persons self-selected as high-risk for HIV
acquisition. Such persons should meet the eligibility criteria stated above.

Recommendations
• PrEP should be taken for a minimum of 7 days in men, and 21 days in women to achieve maximal protection from HIV
acquisition before engaging in high risk sexual exposure and must be continued as long as risky exposure persists or one
remains negative

HIV testing is required before PrEP is offered

• Repeat HIV testing at 1-month post initiation and every 3 months is mandatory while a client is on PrEP
• The frequent HIV testing during PrEP use should also ideally become an opportunity for STI screening and management
• Those who seroconvert while on PrEP should be immediately switched to a standard first line regimen
• PrEP should be provided as part of the combination prevention package (condom use, HTS, family planning, STI screening,
etc.)

Lab Tests before PrEP

• HIV test (only HIV-negative partners should be on PrEP)
• Creatinine (or urinalysis if creatinine not available)
• ALT
• RPR/RST
• Hepatitis B (those with positive results should be on lifelong TDF+XTC to treat HBV)

ARV regimen to be used for oral PrEP

• Tenofovir Disoproxil Fumarate in combination with Emtricitabine (TDF+FTC) is preferred for PrEP
• However, if Emtricitabine is not available, Lamivudine in combination with Tenofovir (TDF+3TC) may be used for PrEP
• Tenofovir alafenamide in combination with Emtricitabine (TAF+FTC) can be used as an alternative in patients with renal
insufficiency (CrCl between 30 – 50 mL/min) or where creatinine is not available. However, it is not currently recommended
for patients on Rifampicin-based TB treatment or pregnant women

Lab Monitoring while on PrEP

• Creatinine at 1 month, 2 months, every 3 months for first 12 months then annually thereafter
• ALT every 3 months for first 12 months then annually thereafter
• Repeat HIV testing is recommended while PrEP is taken at one month and every 3 months
• Necessary lab tests as per indication
• Pregnancy test (especially if the PrEP regimen is TAF-based)

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

T A B L E 2: P R EP F O L L O W - U P

Activity Timing of Visit

Confirmation of HIV-negative status Initial visit, month 1, and then every 3 months

Adherence Counselling Every visit

Side effects Every visit

Initial visit, month 1, 2, then every 3 months for the first year, then
Creatinine Clearance Test
annually
ALT Every 3 months for first year, then annually

STI Screening Every visit

PrEP Drug Dispensation Initial visit, month 1, and then every 3 months
Behavioral sexual risk reduction
Every visit
counselling

Adherence Support on PrEP

• Support for adherence should include information that PrEP is highly effective when used with strict adherence
• PrEP users should be advised that PrEP only becomes effective after 7 days (21 days in women) and must be continued
as long as risky exposure persists and one remains negative
• Brief client-centred counselling that links daily medication use with a daily habit (such as waking up, going to sleep, or a
regular meal) may be helpful
• Special programmes to facilitate adherence among particular groups—such as young people and women—may be needed
• Support groups for PrEP users, including social media groups (for example, https://www.facebook.com/groups/PrEPFacts)
may be helpful for peer-to-peer sharing of experience and challenges
• People who start PrEP may report side effects in the first few weeks of use. These side effects may include nausea,
abdominal cramping, or headache, are typically mild and self-limiting, and do not require discontinuation of PrEP. People
starting PrEP who are advised of this start-up syndrome may be more adherent

When to Stop PrEP

• PrEP can be discontinued if a person taking PrEP is no longer at risk and when this situation is likely to be sustained (i.e.,
no longer engaging in any high-risk behaviors as defined above)
• PrEP should be discontinued after 4 weeks of elimination of the risky exposure
• Significant side effects or if the creatinine clearance decreases to <50mL/min for recipients of care on TDF-based PrEP
regimen
• If in a serodiscordant relationship, the HIV positive partner has been on ART for more than 6 months, is known to be virally
suppressed, and there are no other partners, then the HIV negative partner on PrEP may discontinue therapy. However, for
pregnant or breastfeeding women, PrEP should be continued

19 | Prevention

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

F I G U R E 7: P R EP F L O W C H A R T

Perform HIV testing and screening (TB, STI) Use rapid tests as per
HIV Testing as per National Algorithm guidelines and availability

Treat any present STIs

HIV Positive
HIV Negative HIV positive: Refer to the
Refer all for immediate ART
Potentially eligible for PrEP National Consolidated
initiation, as per guidelines
Guidelines

PrEP risk assesment Clients with acute or

chronic hepatitis B can
be safely initiated onto
PrEP but require liver
PrEP eligibility assessment* function test (LFT)
monitoring

Risk reduction counselling and confirm interest in PrEP

Creatinine (or Urinalysis) and Hepatitis B Screening

Pregnancy test for women

Same day Initiation of PrEP

Provide one month

PrEP prescription
If creatinine clearance
results are <50mL/min
Contact client to stop PrEP
and return for repeat
creatinine test in 2 weeks
Provide ongoing PrEP
education and counselling

Book a follow-up appointment within 28 days and Repeat HIV Test

*for PrEP eligibility assessment, refer to eligibility criteria on page 12

20 | Prevention

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

P OS T -E X P OS URE P R OP H Y L A X I S (PEP)
Post-exposure prophylaxis is the use of ART to prevent HIV transmission. Non-occupational exposure to HIV in children is mostly
due to sexual abuse. In adults, exposure to HIV is mostly associated with occupational injuries. The risk of acquiring HIV infection after
occupational exposure to HIV-infected blood is low (1:300 after percutaneous exposure to <1:1000 after mucocutaneous
exposure).

There is no risk of transmission when the skin is intact. Factors associated with an increased risk include: deep injury, visible blood
on the device that caused the injury, injury with a large bore needle from artery or vein, and unsuppressed HIV viral load in source
patient. Body fluids and materials that pose a risk of HIV transmission are amniotic fluid, cerebrospinal fluid, human breast milk,
pericardial fluid, peritoneal fluid, pleural fluid, saliva in association with dentistry, synovial fluid, unfixed human tissues and organs,
vaginal secretions, semen, any other visibly blood-stained fluid, and fluid from burns or skin lesions. Other blood-borne infections are
hepatitis B and hepatitis C viruses. Thus, all HCWs should receive HBV vaccination.

Management of occupational exposure to infectious substances includes the following steps:

Immediately after exposure:

• Clean the site: wash skin wounds with soap and running water. DO NOT squeeze, allow wound to freely bleed. If the
exposed area is an eye or mucous membrane, flush with copious amounts of clean water. DO NOT USE BLEACH or
other caustic agents/disinfectants to clean the skin
• Contact your In-Charge or supervisor
• Consult the clinical officer or medical officer, who does the following:
§ Determine the need for post-exposure prophylaxis (PEP) based on the risk of transmission and risks and benefits
of taking (or not taking) ART
T A B L E 3: P O S T E X P O S U R E P R O P H Y L A X I S R E C O M M E N D A T I O N S BY RISK CATEGORY

ART Duration
Risk category

No risk: intact skin Not recommended

Medium risk: invasive injury, no blood visible on needle Preferred: TDF or TAF + XTC + DTG
Alternative: TDF or TAF + XTC + DRV-r
High risk: large volume of blood/fluid, known HIV-infected patient, TDF or TAF + XTC + LPV-r
large bore needle, deep extensive injury TDF or TAF + XTC + ATV-r 28 days
AZT + 3TC + LPV-r (children < 20kg)
Penetrative sexual abuse AZT + 3TC + DTG (children ≥ 20kg)
TAF + FTC + DTG (children ≥ 25kg)

Clients on PEP should have an HIV test before starting PEP, 6 weeks and at 3 months.
While on PEP, the client should be reviewed and offered appropriate laboratory
investigations

PEP registers/M&E (separate PEP and PrEP)

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Management of non-occupational exposure to infectious substances should be managed as shown in Figure 8 below:

Non-Occupational Post Exposure Prophylaxis (nPEP) is the provision of ARVs to individuals with significant exposure to HIV within 72
hours. This should be given especially to indivduals who have been sexually assaulted where the HIV status of the assailant is unknown or
in any other circumstance where there is siginifcant exposure to HIV contaminated body fluid.

Clients who come for non-Occupational PEP should be evaluated for substantial risk behaviour for HIV acquisition. Those with
substantial risk or repeated requests for non-Occupational PEP must be counselled for PrEP.

The drugs for nPEP are the same as those for PEP due to occupational exposure as shown above.
F I G U R E 8: A L G O R I T H M FOR EVALUATION AND TREATMENT OF POSSIBLE N O N -O C C U P A T I O N A L HIV
EXPOSURE

Substantial Exposure Risk Negligible Exposure Risk

≤ 72 hours since exposure > 72 hours since exposure

Source patient known to be HIV

positive or of unknown HIV status

nPEP recommended Case by case determination nPEP NOT recommended

Substantial risk for HIV exposure of: Negligible risk for HIV exposure with:
Vagina, rectum, eye, mouth, or other mucous membrane, Urine, nasal secretions, saliva, sweat, or
non-intact skin, or percutaneous contact; tears if NOT visibly contaminated with blood;
With:
Blood, semen, vaginal secretions, rectal secretions, breast Regardless: of the known or suspected HIV
milk, or any body fluid that is visibly contaminated with blood; status of the source
When:
The source is known to be HIV–infected or source’s status
is unknown

22 | Prevention

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

ELIMINATION OF MOTHER TO CHILD TRANSMISSION OF
HIV (EMTCT)

Recommendations

Extended ARV Prophylaxis in HIV exposed Infants

= AZT/3TC + NVP for at least 12 weeks

Viral Load Monitoring in HIV Infected Pregnant and

Breastfeeding Women: Every 3 months

PrEP for Pregnancy and Breastfeeding Women

F I G U R E 9: T H E F O U R P I L L A R S /P R O N G S OF EMTCT

Women of Childbearing Prong 1

Age
Primary Prevention of
HIV among Women of
Childbearing Age

Women living with HIV Prong 2

Prevention of unintended
Prong 4 Pregnancies among
women living with HIV
Provision of appropriate
treatment, care and Pregnant and
support to women, Breastfeeding Women Prong 3
children living with HIV living with HIV
and their families Prevention of HIV from a
woman living with HIV to
her infant
Children living with HIV

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

T A B L E 4: P R E -P R E G N A N C Y AND ADOLESCENTS

Specific Population Description Child-bearing Female with Negative HIV Test Result Child-bearing Female with Positive HIV
Test Result

Pregnancy Screen for Hep B, Syphilis Counsel and continue/Initiate ART

If +ve treat client + partner
1st Trimester Screen for Hep B, Syphilis and OIs
If +ve treat client + partner

• At ANC1, for known +ves on ART,

Counsel and Initiate PrEP if eligible check if VL was done: if >3 months
retest, if >3 months repeat, and
thereafter every 3 months
• For those who initiate ART in ANC do
VL at 3 months, thereafter retest every
3 months
Counsel client and partner on HIV combination prevention
• Provide condoms or information on where to access
condoms, including female condoms Provide condoms or information on where
• Refer to youth friendly services for more comprehensive to access condoms, including female
sexual information, including HIV prevention condoms
• Retest for HIV every 3 months

Screen for Hep B, Syphilis Counsel and continue/Initiate ART

If +ve treat client + partner
2nd Trimester
Screen for Hep B, Syphilis and OIs, if +ve
Counsel and Initiate PrEP if eligible treat client + partner
Counsel client and partner on HIV combination prevention • At ANC1, for known +ves on ART,
check if VL was done: if >3 months
• Provide condoms or information on where to access retest, and thereafter every 3 months
condoms, including female condoms • For those who initiate ART in ANC do
• Refer to youth friendly services for more comprehensive VL at 3 months, thereafter retest
sexual information, including HIV prevention every 3 months
• Retest for HIV every 3 months Provide condoms or information on where
to access condoms, including female
condoms
Screen for Hep B, Syphilis Counsel and continue/Initiate ART
If +ve treat client + partner
3rd Trimester Counsel and Initiate PrEP if eligible Screen for Hep B, Syphilis and OIs, if +ve
treat client + partner
• Check if VL was done/do if not
done and if >3 months repeat
• Repeat viral load 1- 4 weeks before
delivery
Counsel client and partner on HIV combination prevention Provide condoms or information on where
• Provide condoms or information on where to access to access condoms, including female
condoms, including female condoms condoms
• Refer to youth friendly services for more comprehensive
sexual information, including HIV prevention
• Retest for HIV every 3 months

Labor and Do HIV test if done >6 weeks Counsel and continue/Initiate ART
delivery

ANC1 = First antenatal visit; OIs = Opportunistic Infections

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

T A B L E 5: I N F A N T S AND CHILDREN

Specific Description Child-bearing Female with Child-bearing Female with Positive HIV Test Result
Population Negative HIV Test Result

Children Birth • Do HIV test if done >6 HIV Exposed Infant/Child Mother
weeks
• Counsel and Initiate PrEP 1. Send DBS or fresh blood for NAT • Adherence
2. Send blood for syphilis (RPR) Counselling and
if eligible
3. Scheduled immunization continue/Initiate
• Counsel client and partner ART
Positive NAT Negative NAT
on HIV combination • Infant Feeding
prevention • Send fresh DBS or • Initiate AZT+3TC+NVP Counselling
blood for confirmatory prophylaxis for 12 weeks
NAT • If RPR is positive treat for
• Initiate treatment congenital syphilis
AZT+3TC+NVP for 14
and thereafter change
to the ABC+3TC+LPV-r
• If RPR is positive
treat congenital
syphilis

6 weeks • Do HIV test if done >6 Positive NAT Negative NAT • Adherence
weeks Counselling and
• Counsel and Initiate PrEP • Start Co-trimoxazole • Start Co-trimoxazole continue/Initiate
if eligible Continue ART • Send DBS or fresh blood ART
• Counsel client and partner • Scheduled for NAT • Infant Feeding
on HIV combination immunization • Continue ART Counselling
prevention • Newly diagnosed prophylaxis
• If never breastfed stop
• Provide condoms or initiate on
• Scheduled immunization
information on where to ABC+3TC+LPV-r
access condoms, including • Continue adherence
female condoms counselling
• Refer to youth friendly
services for more
comprehensive sexual
information, including HIV
prevention
10 weeks • Do HIV test if done >6 Positive NAT Negative NAT • Viral Load Testing
weeks in the mother `
• Counsel and Initiate PrEP • Continue Co- • Continue Co-timoxazole • Adherence
if eligible trimoxazole. Counselling and
• Counsel client and partner • Continue ART • Continue AZT+3TC+NVP continue/Initiate
on HIV combination • Continue adherence ART
prevention counselling • Scheduled immunization • Infant Feeding
• Scheduled Counselling
• Provide condoms or
information on where to immunization
access condoms, including • Initiate any newly
female condoms diagnosed to
ABC+3TC+LPV-r
• Refer to youth friendly
services for more
comprehensive sexual
information, including HIV
prevention
14 weeks • Do HIV test if done >6 Positive NAT Negative NAT • If mother virally
weeks suppressed
• Counsel and Initiate PrEP • Continue Co- • If mother virally continue same
if eligible trimoxazole. suppressed stop regimen.
• Counsel client and partner • Continue ART AZT+3TC+NVP • Mother not virally
on HIV combination • Continue adherence • Mother not virally take action to
prevention counselling suppressed continue ensure mother is
AZT+3TC+NVP on more efficacious
• Provide condoms or • Scheduled
immunization • Scheduled immunization regimen.
information on where to
access condoms, including
25 | Prevention

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

Specific Description Child-bearing Female with Child-bearing Female with Positive HIV Test Result
Population Negative HIV Test Result

female condoms • Initiate any newly

• Refer to youth friendly diagnosed to
services for more ABC+3TC+LPV-r
comprehensive sexual
information, including HIV
prevention
6 months • Do HIV test if done >6 Positive NAT Negative NAT • Viral load
weeks • Adherence
• Counsel and Initiate PrEP • Continue Co- • Send DBS or fresh blood counseling
if eligible trimoxazole. for NAT • Continue ART
• Continue ART • At next child visit, Stop • Review in 2-4
• Counsel client and partner
• Continue adherence AZT+3TC+NVP weeks with results
on HIV combination
counselling prophylaxis if mother of viral load [within
prevention
suppressed. or at time of next
• Provide condoms or • Scheduled
immunization • Continue AZT+3TC+NVP child visit].
information on where to if mother not suppressed
access condoms, including • Initiate any newly
diagnosed to • If NAT positive start
female condoms
ABC+3TC+LPV-r ABC+3TC+LPV-r
• Refer to youth friendly
• Scheduled immunization
services for more
comprehensive sexual
information, including HIV
prevention
9 months • Do HIV test if done >6 Positive NAT Negative NAT • Viral load
weeks • Adherence
• Counsel and Initiate PrEP • Continue Co- • Send DBS or fresh blood counseling
if eligible trimoxazole. for NAT • Continue ART
• Continue ART • At next child visit, Stop • Review in 2-4
• Counsel client and partner
• Continue adherence AZT+3TC+NVP weeks with results
on HIV combination
prevention counselling prophylaxis if mother of viral load [within
• Scheduled suppressed. or at time of next
• Provide condoms or • Continue AZT+3TC+NVP
immunization child visit].
information on where to if mother not suppressed
• Initiate any newly .
access condoms, including • If NAT positive start
female condoms diagnosed to
ABC+3TC+LPV-r ABC+3TC+LPV-r
• Refer to youth friendly • Scheduled immunization
services for more
comprehensive sexual
information, including HIV
prevention
12 months • Do HIV test if done >6 Positive NAT Negative NAT • Viral load
weeks • Adherence
• Counsel and Initiate PrEP • Continue Co- • Do serology test if counseling
if eligible trimoxazole. positive send DBS or • Continue ART
• Continue ART fresh blood for NAT • Review in 2-4
• Counsel client and partner
• Continue adherence • At next child visit, Stop weeks with results
on HIV combination
prevention counselling AZT+3TC+NVP of viral load. [within
• Scheduled prophylaxis if mother or at time of next
• Provide condoms or suppressed.
immunization child visit].
information on where to • Continue AZT+3TC+NVP
access condoms, including • Initiate any newly
diagnosed to if mother not suppressed
female condoms • If NAT positive start
• Refer to youth friendly ABC+3TC+LPV-r
ABC+3TC+LPV-r
services for more • Scheduled immunization
comprehensive sexual
information, including HIV
prevention

18 months • Do HIV test if done >6 Positive NAT Negative NAT • Viral load
weeks • Adherence
• Counsel and Initiate PrEP counseling
if eligible • Continue ART
• Counsel client and partner • Review in 2-4
on HIV combination weeks with results
of viral load. [within

26 | Prevention

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

 Specific Description Child-bearing Female with Child-bearing Female with Positive HIV Test Result
Population Negative HIV Test Result

prevention • Continue Co- • Do serology test if or at time of next

• Provide condoms or trimoxazole. positive send DBS or child visit].
information on where to • Continue ART fresh blood for NAT
access condoms, including • Continue adherence • At next child visit, Stop
female condoms counselling AZT+3TC+NVP
• Refer to youth friendly • Scheduled prophylaxis if mother
services for more immunization suppressed.
comprehensive sexual • Initiate any newly • Continue AZT+3TC+NVP
information, including HIV diagnosed to if mother not suppressed
prevention ABC+3TC+LPV-r • If NAT positive start
ABC+3TC+LPV-r
• Scheduled immunization
24 months • Do HIV test if done >6 Positive NAT Negative NAT • Viral load
weeks • Adherence
• Counsel and Initiate PrEP • Continue Co- • Do serology test if counseling
if eligible trimoxazole. positive send DBS or • Continue ART
• Continue ART fresh blood for NAT • Review in 2-4
• Counsel client and partner
• Continue adherence • At next child visit, Stop weeks with results
on HIV combination
prevention counselling AZT+3TC+NVP of viral load. [within
• Scheduled prophylaxis if mother or at time of next
• Provide condoms or suppressed.
immunization child visit].
information on where to • Continue AZT+3TC+NVP
access condoms, including • Initiate any newly
diagnosed to if mother not suppressed
female condoms • If NAT positive start
• Refer to youth friendly ABC+3TC+LPV-r
ABC+3TC+LPV-r
services for more • Scheduled immunization
comprehensive sexual
information, including HIV
prevention

Management of an HIV-Exposed Infant (HEI) and Extended Prophylaxis

• ALL HEI should recieve prophylaxis for at least 12 weeks with AZT+3TC plus NVP to be stopped when there is a documented
suppressed viral load in the mother at 3 months post-natally.
• In a situation where the VL of the mother is unsuppressed (or mother not on ART), the prophylaxis should be continued while
closely monitoring for side effects in the baby. This prophylaxis should be extended until the mother is suppressed or four
weeks post breastfeeding ceasation.
• Where the mother refuses to be on treatment, continued counselling should be done and ART initiated as soon as possible
while the baby is on extended prophylaxis.

T A B L E 6: S I M P L I F I E D I N F A N T P R O P H Y L A X I S D O S I N G

Infant age Birth to <6 weeks old > 6 weeks to 12 weeks old

Weight 2000g – 2499g 2500g – 2999g 3000g – 5900g

10mg/5mg twice daily 15mg/7.5mg twice daily Use treatment dose: 60mg/30mg)
AZT/3TC (Suspension) (1mL of suspension twice daily) (1.5mL of suspension twice daily) tablet twice daily

10mg once daily 15mg once daily 20mg once daily

NVP (2mL of syrup once daily or half
(1mL of syrup once daily) (1.5mL of syrup once daily)
a 50mg tablet once daily)

NOTE:
• AZT/3TC is a dispersible tablet containing AZT = 60mg and 3TC = 30mg:
o Dissolve 1 dispersible tablet into 6mL of water; 1mL of the suspension will contain 10mg of AZT and 5mg of 3TC
o Take NOTE that the suspension made should be kept in a cool place! Daily reconstitution is recommended to assure stability of the suspension
o Shake the suspension before use
• For infants weighing <2000g and older than 35 weeks of gestational age, the suggested doses are: NVP 2mg/kg per dose once daily and AZT 4mg/kg
per dose twice daily. Premature infants younger than 35 weeks of gestation age should be dosed using expert guidance.
• Care givers should be educated by the pharmacists and clinicians on how to reconstitute the AZT/3TC dispersible tablets. Care givers should
demonstrate to the pharmacists on how they are reconstituting these formulations

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

MANAGEMENT OF HIV INFECTED
POPULATIONS

Recommendations

Treat ALL regardless of CD4 count or WHO Clinical Stage

TDF+XTC+DTG as preferred first-line in all adult populations

including peri-conceptual period

TafED for Children ≥ 25kg

TLD in Children ≥ 30kg

Genotype Test after treatment failure

Darunavir-r in Second-line ART

T REATMENT OF HIV I NFECTED P OPULATIONS

T A B L E 7: ARV P R E S C R I B E R S AND CORRESPONDING REGIMENS FOR ART I N I T I A T I O N

Cadre with specific training Initiation of ART

Nurse/Midwife (registered, enrolled) certified with Integrated HIV Care Training* 1st line

Nurse Prescribers with Integrated HIV Care Training* 1st line, 2nd line**

Clinical Officers with Integrated HIV Care Training* 1st line, 2nd line**
Medical Licentiates with Integrated HIV Care Training* 1st line, 2nd line
Medical Officers with Integrated HIV Care Training* 1st line, 2nd line

Medical Specialists with relevant training and experience† 1st line, 2nd line, 3rd line

*Providers with Integrated HIV Care Training should satisfy requirements of competency-based training in the use of ART for treatment and prevention
of HIV

**Initiation on Second-Line should only be done in consultation with a medical officer with appropriate training
†Relevant training and experience refer to management of advanced and complicated HIV, including Second-Line treatment failure

To improve ART initiation and adherence, counselling must be done so that the individual (or caregiver) understands its benefits. The
benefits of starting ART earlier include:
o Reduced rates of HIV-related morbidity and mortality
o Reduced MTCT (in pregnant and breastfeeding women)
o Potential reductions in the incidence and severity of chronic conditions (e.g., renal disease, liver disease, certain cancers, and
neurocognitive disorders)
o Reduction in infectious complications (e.g., TB)
o Reduced sexual transmission
o High levels of adherence to ART are needed to attain these objectives.

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

F I G U R E 10: F L O W D I A G R A M FOR HIV C A R E AND TREATMENT FROM HIV T E S T I N G TO ART
INITIATION

HIV testing services (with partner and/or family)

Assign National Unique Patient Number (NUPN) Link to MC and FP services, if desired

HIV-uninfected HIV-infected

• Provide HIV prevention messages and Start CTX if:

connect to VMMC/PrEP/PEP • Child < 5 years old
• Establish partner status • Pregnant woman
• Retest after 3 months • Child ≥ 5 years old /Adolescent/Adult with CD4
count <350 cells/µL, and WHO clinical stage II, III
or IV

Screen for TB, Cryptococcal meningitis and

renal insufficiency

TREAT ALL
• Start all patients tested HIV positive on ART
regardless of CD4 count and WHO clinical
staging
• Baseline tests still have to be done

30 | Management of HIV Infected Populations

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

T A B L E 8: WHO C L I N I C A L S T A G I N G OF HIV D I S E A S E BY SPECIFIC POPULATIONS

Adolescents (15 to 19 years old)

Children (0 to <10 years old)

Pregnant & Breastfeeding Women

Adolescents (10 to 15 years old)

Adults

Clinical Stage 1
• Asymptomatic • Asymptomatic
• Persistent generalized lymphadenopathy • Persistent generalized lymphadenopathy

Clinical Stage 2

• Unexplained persistent hepatosplenomegaly • Moderate unexplained weight loss (<10% of presumed or

• Recurrent or chronic upper respiratory tract infections measured body weight)
(otitis media, otorrhoea, sinusitis, tonsillitis) • Recurrent respiratory tract infections (sinusitis, tonsillitis,
• Herpes zoster otitis media, pharyngitis)
• Lineal gingival erythema • Herpes zoster, Angular cheilitis
• Recurrent oral ulceration • Recurrent oral ulceration
• Papular pruritic eruption • Papular pruritic eruption
• Fungal nail infections • Fungal nail infections
• Extensive wart virus infection • Seborrhoeic dermatitis
• Extensive molluscum contagiosum
• Unexplained persistent parotid enlargement

Clinical Stage 3

• Unexplained moderate malnutrition not adequately • Unexplained severe weight loss (>10% of presumed or
responding to standard therapy measured body weight)
• Unexplained persistent diarrhoea (14 days or more) • Unexplained chronic diarrhoea for longer than 1 month
• Unexplained persistent fever (above 37.5°C, intermittent or • Unexplained persistent fever (intermittent or constant for
constant, for >1 month) >1 month)
• Persistent oral candidiasis (after 6 weeks old) • Persistent oral candidiasis
• Oral hairy leukoplakia • Oral hairy leukoplakia
• Lymph node tuberculosis • Pulmonary tuberculosis
• Pulmonary tuberculosis • Severe bacterial infections (such as pneumonia, empyema,
• Severe recurrent bacterial pneumonia pyomyositis, bone or joint infection, meningitis,
• Acute necrotizing ulcerative gingivitis or periodontitis, bacteraemia)
unexplained anaemia (<8g/dL), neutropaenia (<0.5 x • Acute necrotizing ulcerative stomatitis, gingivitis or
109/L) or chronic thrombocytopaenia (<50 x 109/L) periodontitis
• Symptomatic lymphoid interstitial pneumonitis • Unexplained anaemia (<8g/dL), neutropaenia (<0.5 x
• Chronic HIV-associated lung disease, including 109/L) and/or chronic thrombocytopaenia (<50 x 109/L)
bronchiectasis

31 | Management of HIV Infected Populations

Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

 Adolescents (15 to 19 years old)
Children (0 to <10 years old)

Pregnant & Breastfeeding Women

Adolescents (10 to 15 years old)

Adults

Clinical Stage 4

• Unexplained severe wasting, stunting or severe • HIV wasting syndrome

malnutrition not responding to standard therapy • Pneumocystis (jirovecii) pneumonia
• Pneumocystis jirovecii pneumonia • Recurrent severe bacterial pneumonia
• Recurrent severe bacterial infections (such as empyema, • Chronic herpes simplex infection (or labial, genital or
pyomyositis, bone or joint infection, meningitis, but anorectal of more than 1 month’s duration or visceral at any
excluding pneumonia) site)
• Chronic herpes simplex infection (or labial or cutaneous of • Oesophageal candidiasis (or candidiasis of
more than 1 month’s duration or visceral at any site) trachea, bronchi or lungs)
Oesophageal candidiasis (or candidiasis of trachea, bronchi • Extrapulmonary tuberculosis
or lungs) • Kaposi sarcoma
• Extrapulmonary tuberculosis • Cytomegalovirus infection (retinitis or infection of
• Kaposi sarcoma other organs)
• Cytomegalovirus infection (retinitis or infection of other • Central nervous system toxoplasmosis HIV
organs with onset at > 1 month old) encephalopathy
• Central nervous system toxoplasmosis (after the neonatal • Extrapulmonary cryptococcosis, including meningitis
period) • Disseminated non-tuberculous mycobacterial infection
• HIV encephalopathy • Progressive multifocal leukoencephalopathy
• Extrapulmonary cryptococcosis, including meningitis • Chronic cryptosporidiosis
• Disseminated non-tuberculous mycobacterial infection • Chronic isosporiasis
• Progressive multifocal leukoencephalopathy • Disseminated mycosis (extrapulmonary
• Chronic cryptosporidiosis (with diarrhoea) histoplasmosis, coccidioidomycosis)
• Chronic isosporiasis • Lymphoma (cerebral or B-cell non-Hodgkin)
• Disseminated endemic mycosis (extrapulmonary • Symptomatic HIV-associated nephropathy
histoplasmosis, coccidioidomycosis, penicilliosis) or cardiomyopathy
• Cerebral or B-cell non-Hodgkin lymphoma • Recurrent septicaemia (including non-
• HIV-associated nephropathy or cardiomyopathy typhoidal Salmonella)
• Invasive cervical carcinoma
• Atypical disseminated leishmaniasis

T A B L E 9: E L I G I B I L I T Y C R I T E R I A F O R ART I N I T I A T I O N IN CHILDREN, ADOLESCENTS, PREGNANT AND

BREASTFEEDING WOMEN AND ADULTS

Specific populations Description

Pregnant & Breastfeeding Women

Children (0 to <10 years old)

Treat irrespective of WHO clinical stage or CD4 count
Adolescents (10 to ≤19 years old)

Adults

Under these new guidelines: Treat ALL, the assessment through WHO Clinical Staging (Table 8) guides the
evaluation and management of HIV; however initiating ART does not require a CD4 count

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T A B L E 10: P R E - I N I T I A T I O N T A S K S

Timeline/Specific populations Clinical tasks Laboratory tests*

Visit 1 Enrollment/ Children Complete history & examination Screen for TB Creatinine (calculate CrCl) **
Initiate ART based and other opportunistic infections (OIs) ALT
on patient Adherence counselling and PHDP† messages,
readiness Hb/FBC**
including the caregiver: sessions 1 & 2
CD4 **
WHO clinical assessment
Initiate CTX for child ≥ 6 weeks to ≤ 5 years old HBsAg (if not vaccinated)
Initiate CTX for child 5 to ≤ 10 years if eligible <350 Pregnancy test
cells/µL (Adolescent or woman of
Initiate TPT if TB screening is Negative reproductive age)
HPV vaccine for girl <10 years old
Syphilis test (adolescent or
adult)
Cholesterol, and
Adolescents Complete history & examination triglycerides (especially if
Screen for TB and other OIs starting PI)
Adults WHO clinical assessment HPV test or visual inspection
Initiate CTX if eligible (CD4 <350 cells/µL or WCS I, with acetic acid (VIA) in
II or IV, or pregnancy) sexually active adolescent or
Initiate TPT if TB screening is Negative if not woman
initiated
Adherence counselling and PHDP† messages
Urinalysis.

Visit 2 Children Targeted history and examination Urinalysis

Screen for TB, Cryptococcus, and PCP Sputum AFB smear/
1-2 weeks later GeneXpert MTB RIF in
Review CTX adherence (if already started)
Initiate CTX (if eligible and not initiated at individuals with a
Initiate ART if not
positive screening
initiated at visit 1 enrollment)
Initiate TPT if TB screening is Negative if not Serum CRAG for adolescents
and adults with CD4 count <
initiated
100 cells/µL
Review laboratory test results
Initiate ART if not initiated at visit 1
Adolescents
Adherence counselling and PHDP†
Adults messages, including the caregiver

Visit 3 Children Targeted history and examination Urinalysis

Screen for TB and other OIs Sputum AFB
2-4 weeks from Serum CRAG for adolescents
Adolescents And review CTX adherence
enrollment and adults with CD4 count <
Initiate TPT if TB screening is Negative if not
Initiate ART if Adults initiated 100 cells/µL
not initiated at Initiate ART if not yet started in the last two visits
visits 1 and 2 Adherence counselling and PHDP†
messages

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F I G U R E 11: S A M E D A Y ART I N I T I A T I O N A L G O R I T H M IN ADULTS

Brief Targeted Medical History:

Counselling: Ask about fever, weight loss, cough, persistent headache,
HIV +ve Post test h/o: Kidney Disease, Hypertension, Diabetes, Acute or
counselling and Chronic Diarrhoea, use of NSAIDs (Ibuprofen, Diclofenac,
education Aspirin, Indomethacin), Herbal Medications

Clinical Examination:
Check BP, Weight, Height, BMI + Random Blood Sugar & Urinalysis (where glucostix & urine dipstix tests are available)

? BP > 140/90 ? Chronic use of NSAIDs or Herbal medications

? BMI < 18.5 ? Proteinuria +3 (if urine dipstix test available)

? Severe acute illness ? RBS >11.1 (if glucostix test available)

NO Evidence of above: YES Evidence of above:

Prepare patient for same day ART: Prepare patient for same day ART:
Initiate the following ARVs: ● Screen for TB and Cryptococcal meningitis
● TDF (or TAF) + XTC + DTG ● If positive TREAT these OIs and defer ART
● If HIV/TB and on Rifampicin DTG 50mg twice daily but ● If evidence of renal disease, replace TDF with TAF
avoid TAF Or ABC
● If pregnant or TB avoid TAF
Provide adherence counselling

Patient not ready for ART?

Discuss reasons why and schedule follow up
appointment within 7 days

Draw baseline labs (CD4, Creatinine, Hb, HBV, RPR, ALT), send them for testing and review patient within 14
days to discuss laboratory results:

For Patients on TDF, Creatinine Clearance: For Patients on TAF with Creatinine Clearance
• >50mL/min, continue TDF • Between 50 and 30mL/min, continue TAF
• Between 50 and 30mL/min, replace TDF with TAF • <30mL/min, replace TAF with ABC and
• <30mL/min, replace TDF with ABC and adjust adjust dose of 3TC*
dose of 3TC

*For 3TC dose adjustment, refer to appendix 1

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FIRST-L INE ART
Providing optimized, fixed-dose ART regimens in all populations have consistently demonstrated that there are better clinical and
laboratory outcomes if HIV treatment is initiated early. Reduce the time between HIV diagnosis and c ART initiation. T h i s i s
based on an assessment of the person’s readiness and it is preffered that initiations are done immediately or within 2 weeks.

T A B L E 11: P R E F E R R E D F I R S T -L I N E ART AND ALTERNATIVE REGIMENS BY SPECIFIC POPULATIONS

Specific Populations Description Preferred 1st line ART Alternative regimen

Pregnant & Breastfeeding All TDF + XTC + DTG TDF + XTC + EFV400 or
Womenb ABC + 3TC + DTG*

Children (0-2 weeks) All AZT + 3TC + NVP AZT + 3TC + RAL

AZT + 3TC + LPV-r

< 20 Kg ABC + 3TC + LPV-r
AZT + 3TC + RAL

AZT + 3TC + LPV-r

20 – 24.9 Kg ABC + 3TC + DTG
Children (2 weeks to < 5 years ABC + 3TC + LPV-r
old)

≥ 25 Kg TAF + 3TC + DTG ABC + 3TC + DTG

≥ 30Kg TAF + 3TC + DTG TDF + 3TC + DTG

ABC + 3TC + RAL (Double dose

<20 kg of RAL) or ABC + 3TC + AZT AZT + 3TC + EFV (> 3 months)

ABC + 3TC + DTG

20 – 29.9 kg ABC+3TC+LPV-r
Increase the frequency of
Children co-infected with TB DTG to 50mg twice daily (LPV-r should be superboosted,
otherwise consult expert opinion)
ABC + 3TC + EFV
TDF + 3TC+DTG ABC + 3TC + RAL
≥ 30Kg
Increase the frequency of
DTG to 50mg twice daily

Adolescents (10 to <19 years

old) weighing ≥ 30Kg TDF (or TAF c) + XTCd + EFV400a or
All TDF (or TAFc) + XTCd + DTGe
ABC + 3TC + DTG*

Adults

a.
EFV 400 is the lower dose of EFV-400mg/day and is the preferred ARV agent in HIV/TB patients on TB treatment
b.
If NVP exposure, the alternative regimen is a PI-based therapy
c.
TAF is Tenofovir alafenamide. Avoid in pregnancy and HIV/TB patients on Rifampicin (currently not recommended)
d.
Can either be 3TC or FTC
FTC is not available as a single drug and is expected to be part of the dixed dose combination TAF+FTC+DTG
e.
DTG (Dolutegravir) to be given to ART naïve adolescents and adults. For HIV/TB patients on Rifampicin and cannot tolerate EFV400, increase
the frequency of DTG to 50mg twice daily instead of the usual 50mg once daily where single tablet is available
* ABC+3TC+DTG can be used as an alternative for those with renal insufficiency, or where TAF is not available and EFV is not tolerated

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N EWER A NTIRETROVIRAL A GENTS AND T HEIR U SE
1. Dolutegravir (DTG)

a. Dolutegravir (DTG) is a newer Integrase Inhibitor with a higher genetic barrier to resistance than Raltegravir (RAL) and
Elvitegravir (EVG) and NNRTIs
b. DTG is associated with the following mutations: F121Y, E138A/K, G140S/A, Q148 H/K/R, N155H, R263K.
c. Cross-resistance studies with RAL and EVG-resistant viruses indicate that G140S and Q148 H/K/R in combination with
L74I/M, E92Q, T97A, E138A/K, G140A, or N155H are associated with 5-fold to 20-fold reduced DTG susceptibility
and reduced virological suppression in patients.
d. It is dosed as 50mg dosed as once daily EXCEPT as 50mg twice daily in patients on Rifampicin or those with integrase
mutations
e. It has no food requirements and has few drug interactions
f. It has drug interactions with UDP glucuronyl transferase inducers like Rifampicin, which leads to decreased plasma DTG
levels
g. It also has decreased absorption with aluminum, calcium or magnesium containing anti-acids
h. There is also reported increase in serum creatinine with no true effect on the glomerular filtration rate (GFR)
i. There is no efficacy data on the use of DTG in adolescents younger than 10 years of age.

DTG and Women of Childbearing Potential

DTG based regimens are the recommended first line regimens for all people living with HIV in Zambia, including women of child
bearing potential and children weighing above 20kgs. The benefit of Dolutegravir including greater maternal viral suppression, fewer
maternal deaths, fewer sexual transmissions and fewer mother-to child transmissions out-weigh the minimal risk of foetal neural tube
defects. Current evidence shows that the risk of neural tube defects in DTG use is less significant than what was previously thought.
Therefore, a woman centered approach is recommended where a woman is counselled on the benefits and minimal risks of DTG use
in periconception period and the woman’s autonomy to choose is respected.

Active pharmacovigilance must be done.

Practical hints on use of DTG

• It should be used in the following populations:

o Adults and adolescents with HIV-1 or HIV-2 or HIV-1/HIV-2 mixed infection who are being initiated on ART as part
of combination ART as
§ TDF (or TAF) + XTC + DTG
o Adults and adolescents with HIV-1 who have an undetected viral load while on NNRTI based first line as
§ TDF + XTC + EFV to TDF (or TAF) + XTC + DTG
§ TDF + XTC + NVP to TDF (or TAF) + XTC + DTG
§ ABC + 3TC + EFV to ABC (or TAF) + XTC + DTG
§ ABC + 3TC + NVP to ABC (or TAF) + XTC + DTG
o Adults and adolescents with HIV-2 or HIV-1/HIV-2 mixed infection who have an undetected viral load while on PI
based First-Line as
§ TDF + XTC + LPV-r to TDF (or TAF) + XTC + DTG
§ ABC + 3TC + LPV-r to ABC (or TAF) + XTC + DTG
• In HIV/TB infected populations on Rifampicin who cannot tolerate EFV-400 the following switch should be done:
§ TDF + XTC + EFV to TDF + XTC + DTG
• Increase the frequency of DTG to 50mg twice daily instead of the usual 50mg once daily
§ This switch should be done if viral load is <1,000 copies/mL, if it is >1,000 copies/mL, consider switching
to the following standard Second-Line:
• AZT + 3TC + DTG
o Increase the frequency of DTG to 50mg twice daily instead of the usual 50mg once daily
• AZT + 3TC + LPV-r
o the dose of LPV-r should be doubled

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 § However, where the single 50mg tablet is not available the following switch should be done:
• TDF + XTC + EFV to TDF + XTC + LPV-r
o the dose of LPV-r should be doubled
§ This switch should be done if viral load is <1000 copies/mL, if it is >1000 copies/mL, consider switching to
the following standard Second-Line:
• AZT + 3TC + LPV-r
o the dose of LPV-r should be doubled

• DTG significantly increases Metformin plasma levels, which can be partially explained by Organic Cation Transporter-2
inhibition. It is recommended that dose adjustments of Metformin be considered to maintain optimal glycaemic control when
patients are starting/stopping DTG while taking Metformin
o In patients taking DTG who are starting Metformin, begin with low Metformin dose and titrate up carefully.
Recommended dose limit of Metformin 1000 mg daily. If patient is already on Metformin and initiating DTG, monitor
glucose, haemoglobin a1c, and Metformin adverse effects and adjust dose as necessary.

2. Tenofovir alafenamide (TAF)

Tenofovir alafenamide is a phosphonoamidate prodrug of the nucleotide analog Tenofovir (TFV) which belongs to a class of
Nucleotide reverse transcriptase inhibitors. It is predominantly metabolized intracellularly to Tenofovir which undergoes subsequent
phosphorylations to yield the active Tenofovir diphosphate (TFV-DP) metabolite which inhibits the activity of HIV reverse transcriptase
by competing with natural substrates and causing DNA chain termination after being incorporated into viral DNA
a. TAF is dosed as 25mg once daily (when used without pharmaco-enhancers)
b. TAF has also demonstrated I N VITRO and I N VIVO activity against HBV
c. The median terminal half-life of TAF is 0.51 hours and the active metabolite, TFV-DP, has an intracellular half-life of 150 to
180 hours
d. TAF is intracellularly metabolized in hepatocytes, peripheral blood mononuclear cells (PBMCs) and macrophages and less
than 1% of the dose is excreted in the urine and 31.7% excreted in feces
e. TAF has been associated with K65R and the K70E substitutions which lead to reduced susceptibility to Abacavir, Didanosine,
Emtricitabine, Lamivudine, and TDF. HIV-1 containing multiple thymidine analog mutations (TAMs) (M41L, D67N, K70R,
L210W, T215F/Y, K219Q/E/N/R) lead to resistance to TAF. In addition, multi-nucleoside resistant virus with a T69S double
insertion mutation or with a Q151M mutation complex including K65R exhibit I N VITRO resistance to TAF
f. Adverse events include diarrhoea, fatigue, nausea, and rash
g. TAF is associated with significantly less increase in proximal tubular proteinuria and less reduction in estimated glomerular
filtration rate (eGFR) when compared to TDF
h. TAF is associated with significantly less change in spine and hip bone mineral density (BMD) compared to TDF
There is no safety and efficacy data on the use of TAF in pregnant women and people with HIV/TB co-infection

Practical hints on use of TAF

• It should be used in the following populations:
o Adults and adolescents with HIV-1 or HIV-2 or HIV-1/HIV-2 mixed infection who are being initiated on ART as part
of combination ART as
§ TAF + XTC + DTG
o Adults and adolescents with HIV-1 who have an undetected viral load while on NNRTI based First-Line as
§ TDF + XTC + EFV to TAF + XTC + DTG
§ TDF + XTC + NVP to TAF + XTC + DTG
§ ABC + 3TC + EFV to TAF + XTC + DTG
§ ABC + 3TC + NVP to TAF + XTC + DTG
o Adults and adolescents with HIV-2 or HIV-1/HIV-2 mixed infection who have an undetected viral load while on PI
based First-Line as

§ TDF + XTC + LPV-r to TAF + XTC + DTG

§ ABC + 3TC + LPV-r to TAF + XTC + DTG

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 • It is not yet recommended for use in HIV/TB infected populations
o It is therefore recommended that such patients are on TDF or ABC containing regimen instead of TAF containing
regimen
• It is not yet recommended for use in HIV infected individuals who are pregnant
o It is therefore recommended that such patients be switched to TDF or ABC containing regimens instead of a TAF
containing regimen

For programmatic puposes, TAF will be prioritized for the following populations (if eligible);
• Women 45 years and above
• Men 50 years and above
• Creatinine clearance between 30 and 50 mL/min
• Children 25kgs and above
• All those initiated on TAF must continue on TAF unless a contraindication arises

Practical Hints for EFV-400mg initiation

• EFV400 is the alternative to DTG for adults and adolescents being initiated on ART including Pregnant and Breastfeeding
Women and those with TB.
o Consider using EFV-400mg unless there are contraindications to its use, see

• EFV400 is the preferred drug in HIV/TB patients on Rifampicin

• EFV- 600mg is associated with central nervous system (CNS) side effects (e.g. dizziness, drowsiness, insomnia,
abnormal dreams, and impaired concentration).
o In systematic reviews, there is evidence showing that EFV-400mg is comparable to EFV-600mg in terms of viral
suppression, but better in terms of CD4 cell count recovery and protective in terms of treatment discontinuation
because of adverse events. When compared with the standard dose of EFV, EFV-400mg is also associated with
lower toxicity, lower cost, and smaller pill size. It is also comparable to other treatment regimens with respect to mortality
or AIDS-defining illnesses and emergent serious adverse events.
• If CNS effects persist beyond 6-8 weeks on EFV-400mg substitute to PI-based regimen in situations where DTG cannot be used
or tolerated.
• Avoid fatty meals 4 hours before or after taking EFV. Recommend taking EFV before bedtime.
• EFV should not be used to treat patients with HIV-1/HIV-2 co-infections or HIV-2 mono-infection.
See section on HIV-2 Treatment.
F I G U R E 12: A L G O R I T H M FOR C H O O S I N G DTG OR EFV-400 M G IN P A T I E N T S I N I T I A T I N G ART

Always use DTG unless there are contraindications Contraindications for DTG
Significant insomnia, anxiety, depression
and hypersensitivity reactions
PRIMARY INSTI-DOLUTEGRAVIR (DTG)
Co-infection of HIV with TB and EFV400
cannot be tolerated (DTG in this case is
supposed to be dosed as 50mg twice daily
for those on Rifampicin-based treatment)
Is there a contraindication to DTG?

NO YES
Yes

Select DTG Select EFV-400mg

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3. Darunavir-ritonavir (DRV-r)

a. Darunavir-ritonavir is a boosted protease inhibitor with efficacy and tolerability superior to Lopinavir-ritonavir and Atazanavir-
ritonavir. Until recently widespread adoption of DRV-r has been hampered by the lack of an affordable generic fixed dose
combination
b. DRV-r has virologic outcomes comparable to ATV-r and RAL, and a lower rate of discontinuation compared to ATV-r.
c. DRV-r leads to higher viral suppression and fewer discontinuations compared to LPV-r
d. DRV-r can continue to be used in third-line (after failure of a PI) with increased dose given high barrier to resistance.
e. The recommended oral dose for adult patients is as follows:
1. Adult PI treatment-naïve patients: two 400/50 mg tablets taken once daily (800/100 mg once daily)
2. Adult PI treatment-experienced patients including third-line patients: DRV 600 mg taken with ritonavir 100 mg twice
daily
3. Pregnant patients: DRV 600 mg taken with ritonavir 100 mg twice daily except where viral load is already
undetectable and the increased dose would be detrimental to adherence or is not available
f. DRV-r must be administered with food to achieve the desired antiviral effect
g. Adverse events include diarrhea, nausea, rash, headache, abdominal pain and vomiting
h. Discontinue DRV-r immediately if signs or symptoms of severe skin reactions develop (including but not limited to severe
rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis,
hepatitis and/or eosinophilia)
i. Patients suspected of or with underlying liver disease should be monitored for elevation of liver enzymes during first several
months of treatment
j. Precaution should be taken when DRV-r is co-administered with drugs dependent on CYP 3A enzyme system for clearance
e.g. in TB treatment (Rifampicin, Rifapentine), Antibiotics (e.g. Clarithromycin), Antifungals (e.g. Fluconazole), Anti-
epileptics (e.g. Phenytoin)
k. The combination of DRV-r and Artemether/Lumefantrine can be used without dose adjustments; however, the combination
should be used with caution as increased lumefantrine exposure may increase the risk of QT prolongation
l. Effective alternative (non-hormonal) contraceptive method or a barrier method of contraception is recommended
1. For co-administration with drospirenone, clinical monitoring is recommended due to the potential for hyperkalemia
2. No data are available to make recommendations on coadministration with other hormonal contraceptives
Practical hints on use of DRV-r
• It is recommended for use by patients failing first-line DTG-based regimens
• DRV-r may be given in combination with DTG
• DRV-r can be used after ATV-r or LPV-r (and even DRV-r) failure when administered at the higher 600/100 mg twice daily
dose
• DRV-r should NOT be used in HIV/TB infected populations when TB treatment includes rifampicin
o It is therefore recommended that such patients receive an LPV-r containing regimen instead of a DRV-r containing
regimen during TB treatment when Rifampicin is used
o DRV-r may be used in TB treatment with Rifabutin, or in drug-resistant TB patients where rifampicin is not part of the
regimen

4. Long Acting Injectable ARVs

Long acting injectable ARVs comprising of Cabotegravir and Rilpivirne are pending approval for widespread use.
These will be rolled out in Zambia once available, starting with selected populations

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HIV-2 T REATMENT
Clinicians should:

• Use the preferred standard First-Line regimen TDF (or TAF) + XTC + DTG
o If unable to tolerate DTG, substitute with a Lopinavir-ritonavir when prescribing ART for HIV-2 mono-infected or
HIV-1/ HIV-2 co-infected individuals
• Not prescribe NNRTIs (NVP, EFV or RPV) or the PI Atazanavir-ritonavir as part of an ART regimen against HIV-2 mono-
infection
• Consult with a provider with the ATCs in the management of HIV-2 where there are doubts before initiating ART in HIV-2-
infected patients
• Educate patients with confirmed HIV-2 infection about the types of drugs that can be used to treat it

No randomized clinical trials have been conducted to determine when to initiate ART in the setting of HIV-2 infection, and the
best choices of therapy for HIV-2 infection remain under study. Because the optimal treatment strategy for HIV-2
infection has not been defined, the recommendations provided in this section are based on this committee's expert opinion
with supporting evidence highlighted in Table 12 below.

Although HIV-2 is generally less aggressive, and progression to AIDS is less frequent, HIV-2 responds less predictably to ART when
progression occurs, and response is more difficult to monitor. The standard methods and interpretation protocols that are used
to monitor ART for HIV-1-infected patients may not apply for HIV-2-infected patients. Some ART regimens that are appropriate for
HIV-1 infection may not be as effective for HIV-2. The following factors should be considered:

• The majority of HIV-2-infected patients are long-term non-progressors

• HIV-2 may confer more rapid resistance to ART agents because of wild-type genetic sequence that results in a significant
increase in resistance to ART agents compared with HIV-1
• Pathways for the development of drug mutations may differ between HIV-1 and HIV-2

T A B L E 12: P R E F E R R E D F I R S T -L I N E ART AND ALTERNATIVE REGIMENS FOR HIV-2

Specific Populations Description Preferred 1st line ART Alternative regimen

TDF or TAF + XTC + LPV-r d (or

a
Adolescents and adults TDF (or TAF ) + XTC + DTG b DRV – r) or
HIV-1 / HIV-2 co-infected ABC + 3TC + LPV-r o r
(DRV-r)
ABC + 3TC +DTGf

Children ABC + 3TC + LPV-r

HIV-1 / HIV-2 co-infected

a. TAF should also be avoided in pregnancy and in HIV/TB patients on Rifampicin

b . DTG is active against HIV-1 and 2.

d. LVP-r is the only PI that actively works against HIV-2

e. For the alternative regimen for children, refer for consultation or call Toll Free 7040

f. ABC + 3TC + DTG could be used as an alternative for those with renal insufficiency or where TAF is not available and LPV-r is not tolerated

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T A B L E 13: E F F I C A C Y OF ANTIRETROVIRAL THERAPY AGAINST HIV-2 I N F E C T I O N

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

• Although most in vitro studies have shown that similar concentrations of NRTIs are needed to block both HIV-1 and HIV-
2 replication, data suggest that some NRTIs may not be as effective against HIV-2.

o For example, HIV-1 more readily incorporates Zidovudine and is more susceptible to Zidovudine than HIV-2,
and there is a lower barrier to resistance with HIV-2 than with HIV-1.

• Genotypic analysis of HIV-2-infected patients on ART has shown that many of the same amino acid substitutions that are
associated with NRTI resistance in HIV-1 may be implicated in HIV-2. Some resistance mutations (K65R, Q151M, and
M184V) in combination can confer class-wide NRTI resistance and cause rapid virological failure.

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

• NNRTIs block HIV-1 reverse transcription through a specific binding site that is not present in HIV-2; this class of drugs
will not be effective against HIV-2.
• HIV-2 appears to be intrinsically resistant to NNRTIs; the Y188L polymorphism appears naturally in all HIV-2 isolates.
Reversion to Y188 restores the reverse transcriptase sensitivity to some NNRTIs, including Efavirenz
• In general, NNRTIs inhibit HIV-2 at effective concentrations that are at least 50-fold higher than those that inhibit HIV-1,
making the use of these drugs for HIV-2 infection problematic.
• Etravirine appears to have limited activity against HIV-2, but this may not be clinically relevant because the mean 50%
effective concentration in MT4 cells is 2500-fold higher than that observed for HIV-1.

Protease Inhibitors (PIs)

• HIV-2 expresses natural polymorphisms in the protease that may be implicated in emergent drug resistance and
accelerate time to development of PI resistance.
• One study noted that the pathways for HIV-2 protease drug resistance may differ from those for HIV-1.
• Saquinavir, Lopinavir, and Darunavir have shown comparable activity against HIV-1 and HIV-2.
• Atazanavir has lower and variable activity against HIV-2 in comparison with HIV-1. It should not be prescribed for HIV-2 and in
HIV/TB patients on Rifampicin-based treatment.
• Lopinavir dose should be doubled for HIV/TB patients on Rifampicin-based treatment.

Integrase Strand Transfer Inhibitors (INSTIs)

• Dolutegravir is safe for use in HIV-2
• The integrase inhibitors Raltegravir and Elvitegravir have demonstrated activity in vitro. Clinical response to Raltegravir
was reported in a patient with highly treatment-experienced HIV-2 infection but the emergence of mutations was
reported in another patient.
CCR5 co-receptor antagonists
• The activity of Maraviroc has been limited to patients with CCR5-tropic viruses.
• Primary HIV-2 isolates can utilize a broad range of co-receptors, including CXCR4, CCR5, CCT-5, GPR15, and
CXCR6. This limits the therapeutic utility of Maraviroc in HIV-2 infection.

Fusion inhibitors
• HIV-2 is intrinsically resistant to the fusion inhibitor Enfuvirtide.

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MONITORING HIV INFECTED POPULATIONS
ON ART

Recommendations

Treat ALL regardless of CD4 count or WHO Clinical Stage

TDF+XTC+DTG as preferred first-line in all adult populations

including peri-conceptual period

TafED for Children ≥ 25kg

TLD in Children ≥ 30kg

Genotype Test after Treatment Failure

CLINICAL AND LABORATORY MONITORING

Monitoring consists of two components: Clinical and Laboratory

• Clinical monitoring includes history and examination, as well as evaluation of adherence, side effects and relevant drug
toxicities

• Laboratory tests need to be conducted routinely and as needed Table 1. It includes CD4 count, viral load and toxicity monitoring

The purpose of monitoring includes:

• Evaluation of treatment response and diagnose treatment failure early

• Evaluation of adherence

• Screening for Pulmonary tuberculosis

• Detection of toxicity to ARV drugs

Viral load is recommended as the preferred monitoring approach to determine the performance of ART in an individual. If viral load is
not routinely available, CD4 count and clinical monitoring should be used

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F I G U R E 13: V I R A L L O A D M O N I T O R I N G IN PATIENTS ON ART

Patient on ART for ≥6 months

Viral Load at 6months

VL: <1000 copies/mL VL: >1000 copies/mL

Enhanced adherence*
• Continue adherence support and ART
• Repeat VL at 12 months post-initiation
then routine annual VL

Repeat VL within 3 months after last VL

• If >1000copies/mL = VIROLOGICAL
FAILURE
st nd
• If on 1 line, switch to standard 2
line and collect blood for genotype
o Modify 2nd line ART according
to genotype result
nd
• If on 2 line, do genotype and then
consult ATC

• Priority should be given to samples for Children when there are limitations to performing Routine Viral Load Testing
• Children may require more frequent viral load monitoring
• Enhanced adherence: 2 weekly scheduled visits for focussed monitoring and adherence reinforcement

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Genotype Test after HIV Treatment Failure

Genotype test informs the clinician on the type of HIV drug resistance mutations and helps them to select thte appropriate drugs for
therapy. Routine resistance testing is important for the surveillance of HIV drug resistance in the population. HIV genotype resistance
test will be done on all patients after treatment failure and have completed EAC with a repeat VL.

The test must be performed only on patients who have evidence of being adherent to ART for at least 30 days. It should NOT be
done on patients who are not currently taking ARVs even though the VL is high. Such patients should be subjected to EAC until there
is evidence of being adherent to ART. Patients failing first line treatment must be switched to the standard second line according to
the guidelines without waiting for the genotype results. The secondline regimen can be modified once the genotype results are out.

Genotype results are interpreted using a standard software (e.g. Stanford Database) and their use to modify the treatment must be
done in consultation with an HIV specialist or physician/paediatrician experienced in the management of HIV drug resistance cases.

The test will be performed in centralized laboratories (UTH and ADCH). Therefore, all genotype test samples must be couriered using
in cold chain at -20 c using Nitrogen or dry ice. See Figure 14 below:

F I G U R E 14: V I R A L L O A D M O N I T O R I N G IN PREGNANT AND BREASTFEEDING WOMEN ON ART

Known Positive on ART ³ 3 months Known Positive on ART < 3 months/Newly

initiated on ART

Check if VL is on file. If
not, trace result

If VL result ³ 3 months old If VL result < 3 months old If VL result not found

• Do VL • Do VL at 3 months • Do VL • Do VL at 3 months
• Retest every 3 months from last VL • Retest every 3 months from last VL
• If pregnant, book for • Retest every 3 months • If pregnant, book for • Retest every 3 months
VL retest within 4 • If pregnant, book for VL retest within 4 • If pregnant, book for
weeks before EDD VL retest within 4 weeks before EDD VL retest within 4
weeks before EDD weeks before EDD

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T A B L E 14: C L I N I C A L AND L A B O R A T O R Y M O N I T O R I N G – G E N E R A L ART P O P U L A T I O N
Timeline Clinical tasks Laboratory tests
Enrollment and ART initiation î History and examination î Serum creatinine
î ALT
î Screen for TB, Cryptococcus
î Hb or FBC
î Adherence counselling î Blood glucose
î CD4 count
î PHDP† messages
CrAg Tests for those with CD4 cell count
î Initiate ART after adherence counselling <100 cells/microL or WHO Stage III/IV
Urine-LAM CrAg Tests for those with CD4
î If no signs and symptoms of active TB
disease, initiate IPT (i.e. after ruling count <100 cells/microL or WHO Stage III/IV
out TB) î HBsAg
î Syphilis test
î Urinalysis for protein and glucose, RBCs
î Cholesterol, and triglycerides
(especially if starting PI)

Week 2 post-initiation î Targeted history & examination î Serum creatinine (if on TDF)
î Screen for TB, Cryptococcus î Urinalysis (if on TDF)
î Review adherence, side effects, toxicity
î Review laboratory tests

î Adherence counselling
Week 4 post-initiation î Targeted history & examination î Serum creatinine (if on TDF)
î Screen for TB, Cryptococcus î Urinalysis (if on TDF)

î Review adherence, side effects, toxicity

î Adherence counselling
Week 12 post-initiation î Review adherence, side effects, toxicity* î Serum creatinine (if on TDF)
î Urinalysis (if on TDF)
î Adherence counselling
î PHDP† messages
Review laboratory tests
î Refill ART with enough supply to next visit
(maximum: 3 months of supply

6 months post-initiation î Review adherence, side effects, toxicity* î Viral load

î CD4 cell count *
î Adherence counselling î Serum creatinine (if on TDF)
î Urinalysis (if on TDF)
î PHDP† messages
î Cholesterol, and triglycerides
î Review laboratory tests (especially if on PI)

î Refill ART with enough supply to next visit

(maximum: 3 months of supply unless
transferred to appropriate DSD models)
12 months post-initiation and every î Review adherence, side effects, toxicity* î Viral load
12 months î CD4 cell count *
î Adherence counselling î Serum creatinine (if on TDF)
î PHDP† messages î Urinalysis (if on TDF)
î Review laboratory tests î Cholesterol, and triglycerides
î Refill ART with enough supply to next visit (especially if on PI)
(maximum: 3 months of supply unless
transferred to appropriate DSD models)

Those with CD4 cell count >350 cell/microL at baseline and at 6 months of ART with. Suppressed viral load should NOT have
subsequent repeat CD4 cell count monitoring as long as the viral load remain suppressed.

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T A B L E 15: C L I N I C A L A N D L A B O R A T O R Y M O N I T O R I N G FOR HIV-I N F E C T E D P R E G N A N T AND
BREASTFEEDING WOMEN

Timeline Clinical tasks Laboratory tests

Day 0: Enrollment & ART initiation î History and examination î Serum creatinine

î If pregnant, focused ANC (FANC) î ALT

î Screen for TB, Cryptococcus î Hb or
FBC
Blood
î Adherence counselling î glucose
CD4 count
î PHDP† messages î HBsAg
î Initiate ART after adherence î Syphilis test
counselling
î If no signs and symptoms of active TB î Viral load testing at first
disease, initiate IPT (i.e. after ruling out contact if eligible (refer to
TB) Table 14) for those on ART
î Urinalysis for protein
and glucose, RBCs
î cholesterol, and triglycerides

(especially if starting PI)

Week 2 post-initiation î Serum creatinine

î Targeted history & examination î Urinalysis

Week 4 post-initiation î Screen for TB, Cryptococcus, and other î As needed
OIs
Subsequent visits to occur per: î If pregnant, ANC Viiral load to be done every 3
months during pregnancy and
î ANC if pregnant î Review adherence, side effects, breastfeeding period
î HEI schedule if toxicity*
î Serum creatinine and
postnatal and î Adherence counselling urinalysis at every ANC visit
breastfeeding
î PHDP† messages
Laboratory testing to occur
î Adult ART schedule if Review laboratory tests per: ANC while pregnant
postnatal and not
î Refill ART with enough supply to next except for viral load
breastfeeding
visit (maximum: 3 months of supply î VL within 4 weeks before
labour & delivery

Cholesterol and triglycerides to

be done at 6 months post ART
initiation during pregnancy

Follow adult ART schedule

when postnatal except for
viral load

First postnatal visit î CD4 cell count to determine need for continuation of Co-trimoxazole

24 months after delivery î ART dispensed in MNCH until transferred

î Transfer to ART clinic for continuum of HIV care and treatment

î Earlier transfer or referral may be done for logistical reasons or
complicated cases
†
Positive Health Dignity and Prevention (PHDP) includes: risk reduction, ART adherence, correct condom use, family planning, STI
screening, and partner HIV testing
* See Appendix 3 regarding WHO toxicity estimate
* Consider a woman who fails to initiate ART
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M ONITORING D RUG SIDE E FFECTS AND T OXICITIES

Changing an ARV drug should be done only after careful review of adherence. The indication for changing needs to be addressed. A
specific ARV drug may be changed (substitution) because of:

• Toxicity, such as anaemia, peripheral neuropathy, lipodystrophy, liver or renal abnormalities

• Intolerance or unresolved and prolonged side effects

• Poor adherence: change indicated only to simplify dosing schedule and to improve adherence

• Occurrence of active TB (refer to section on TB-HIV co-infection)

• Failure (clinical, immunologic, or virological)

When patients are switched to alternative regimen (see Table 16) the goals are to achieve HIV viral suppression, avoid adverse events,
and optimize adherence.

Always do Viral load and ensure that the patient is suppressed before switching across cases

T A B L E 16: C O M M O N ART T O X I C I T I E S AND RECOMMENDED SUBSTITUTES (FOR ALL POPULATIONS)

ARV drug Common associated toxicity Recommended ARV substitute

ABC Hypersensitivity reaction TAF, or

TDF (if normal creatinine clearance or if child >= 30Kg), or

AZT (if child <25 Kg)

ATV-r Hyperbilirubinaemia, DRV-r, LPV-r

AZT*** Severe anaemia or neutropenia, severe TDF or ABC (if on 1st line ART regimen; rule out failure before
gastrointestinal intolerance, lactic acidosis substitution)

TAF

Consult next level if on 2nd line

DTG Insomnia, anxiety, depression, weight gain** EFV-400, ATV-r or LPV-r or DRV-r
and hypersensitivity reactions

EFV Severe or persistent CNS side effects DTG, ATV-r or LPV-r or DRV-r
LPV-r Persistent diarrhoea, hyperlipidaemia DTG if naïve

RAL if in children,

NVP (or EFV) Rash, Stevens Johnson Syndrome, hepatitis DRV-r or ATV-r
DTG, ATV-r or LPV-r
RAL Rash and hypersensitivity reaction DTG, ATV-r or LPV-r
TAF Gastrointestinal symptoms, headache Rarely causes significant side toxicities, if occurs consult expert
advice
TDF Renal toxicity (renal tubular dysfunction) ABC or TAF

*Hyperbilirubinaemia and icterus do not reflect hepatic disease and are not contraindications to continued therapy. Only substitute ATV-r if
the condition is intolerable to the patient.

* for patient with weight gain, a patient centered approach must be taken considering a patient’s concerns, the level of BMI (>30) and the
proportion of change (>10%). A healthy life style must be promoted. Consider monitoring for serum glucose level, BP and serum lipid level.

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Safety monitoring (Pharmacovigilance)

Pharmacovigilance (PV) relates to the science and activities relating to detecting, assessing, understanding, and preventing adverse
effects or any other drug-related problems. Monitoring the safety of medicines is a critical component of Zambia’s national patient
monitoring system as knowledge of adverse drug reactions and drug interactions helps to generate much-needed safety data to help
improve care and treatment outcomes for patients including people living with HIV.

All healthcare workers, recipients of care/consumers, manufacturers/distributers and the general public are encouraged to report
safety issues such as adverse drug reactions, medication errors and quality problems. Everyone is encouraged to report as soon as
possible even when not sure or does not have all the information. Reporting can be made using various tools which the Ministry of
Health has put in place through the Zambia Medicines Regulatory Authority (ZAMRA). These reporting tools are:

1. Paper ADR report form which can be accessed from your pharmacy department
2. Mobile phone application Med Safety for android and IOS platforms, found on Play Store and iStore respectively
3. Electronic reporting form on the ZAMRA website; http://www.zamra.co.zm

NB. Paper ADR reporting forms should be submitted/sent/mailed as soon as possible to:

The National Pharmacovigilance Unit (NPVU)

Zambia Medicines Regulatory Authority
P.O Box 31890, Lusaka, Zambia
Email: [email protected]
Tel: +260211220429

In the event one is unable to submit directly to NPVU at ZAMRA, forms can be submitted through the following reporting centers:

1) ZAMRA regional offices

2) Regional Pharmacovigilance centers
3) District Health Office
4) Provincial Health Office
5) Responsible officer/In-charge of the dispensary or community pharmacy
6) Posted at the nearest post office (Zambia Postal Services)

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F I G U R E 15: A L G O R I T H M FOR DIAGNOSING TREATMENT FAILURE WITH ROUTINE VIRAL LOAD
MONITORING

Diagnosing Treatment Failure with Routine Viral Load Monitoring

Order ROUTINE HIV Viral Load (HIV VL)

HIV VL > 1000 copies/mL HIV VL <1000 copies/mL

Repeat VL within 3 months

If VL > 1000 copies/mL NO TREATMENT FAILURE

VIROLOGICAL FAILURE
î Reassess adherence
î Enrol patient in intensive adherence î Continue current ART
program î Treat OIs
î Switch to 2nd line ART and ensure î If patient still ill, examine and treat
accordingly
adherence
î Do genotype and then consult ATC
î Follow up:
• Review in 2 weeks
• Reassess adherence, side effects,
toxicity

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 MANAGEMENT OF TREATMENT FAILURE
Patients on ART who have a viral load >1000 copies/mL are failing the treatment and at risk of progression of the HIV disease. Poor
adherence is the commonest cause of treatment failure. Adherence barriers must be evaluated and corrected before the therapy is
changed.

Patiens failing treatment are prone to opportinutic infections and a comprehensive evaluation of the opportunistic infections, especially
Tuberculosis, must be done before therapy is changed.

When patients are switched to Second-Line ART regimens, the goals are to achieve HIV viral suppression resulting in reconstitution of
the clinical and immunologic status, avoid adverse events, and optimize adherence. LPV-r is the primary recommended Second-
Line PI (see Figure 16).

T A B L E 17: R E C O M M E N D E D S E C O N D -L I N E ART R E G I M E N S BY SPECIFIC POPULATIONS

Specific populations Initial 1st line category Failing 1st line ART 2nd line ART
Children <5 years old LPV-r-based First-Line regimen
ABC + 3TC + LPV-r AZT + 3TC + RAL
LPV-r-based First-Line regimen
Children 5-10 years old
NNRTI-based First-Line regimen (ARV naïve) ABC + 3TC + EFV AZT + 3TC + LPV-r
TDF + XTC + DTG*
TAF + XTC + DTG*

DTG and NNRTI-based ABC + 3TC + DTG*

AZT + 3TC + LPV-r (or
Adolescents and First-Line regimen TDF + XTC + EFV**
ATV-r)
Adults ABC + 3TC + EFV**
TDF + XTC + NVP**
ABC + 3TC + NVP**
Pregnant & Breastfeeding TDF + XTC + EFV** AZT + 3TC + LPV-r (or
NNRTI-based First-Line regimen
Women ATV-r)
ABC + 3TC + EFV**
* Represents newer regimens
* *Represents older regimens

T A B L E 18: S U M M A R Y OF P R E F E R R E D S E C O N D -L I N E ART R E G I M E N S FOR ADULTS AND

ADOLESCENTS

Specific populations Preferred 2nd line ART

Adults and adolescents If AZT was used in First-Line ART TDF + XTC + LPV-r (or ATV-r)

If TDF or TAF was used in First-Line ART AZT + 3TC + LPV-r (or ATV-r)

Pregnant or breastfeeding Same regimens as recommended for adults and adolescents if no previous NVP
women exposure without tail coverage
TDF (or TAF) + XTC+ DTG (50mg twice daily)
If DTG not available:
If AZT +3TC + EFV (or NVP) was used in Double dose LPV-r (LPV-r-800mg/200mg twice daily)
On the First-Line ART
Rifampicin
based TB
treatment AZT + 3TC + DTG (50mg twice daily)
HIV & TB
If TDF (or ABC) + XTC + EFV (or If DTG is not available:
Co-infection
NVP) was used in First-Line ART Double dose LPV-r (LPV-r-800mg/200mg
twice daily)

On Rifabutin
based TB If Rifabutin available use same PI regimens as recommended for adults and adolescents
treatment

HIV and HBV co-infection AZT + TDF + XTC* + LPV-r (or ATV-r)
* TDF+XTC should always be part of the combination in HBV/HIV co-infections

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T A B L E 19: R E C O M M E N D E D S E C O N D -L I N E ART R E G I M E N S FOR HIV-2

Specific populations Initial 1st line category Failing 1st line ART 2nd line ART

HIV-1 / HIV-2 Co-infected DTG - based First-Line regimen TDF + XTC + DTG AZT + 3TC + LPV-ra

HIV-2 mono-infected ABC + 3TC + DTG AZT + 3TC + LPV-ra

a DO NOT substitute with Atazanavir in HIV-1/HIV-2 con-infection or HIV-2 mono-infection. Atazanavir is not active against HIV-2

F I G U R E 16: A L G O R I T H M FOR CHOOSING A PI IN S E C O N D -L I N E

Cautions for LPV-r

PRIMARY PI – Lopinavir-ritonavir (LPV-r) Porphyria

GI Intolerance
Hyperglycaemia
Hyperlipidaemia

Is there a caution to use LPV-r?

NO YES

NO
Select ATV-r

Does the patient

Select LPV-r have TB or
Hyperbilirubinaemia o If TB & on Rifampicin
and DTG not used
or Jaundice? before, use DTG 50mg
YES
twice daily
o If hyperbilirubinaemia &
DTG not used before, use
DTG 50mg once daily

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CLINICAL G U I D A N C E ON USE OF ATV-R

Administration

• ATV-r is given once a day (300/100mg)

• Do not split or crush ATV-r tablets
• ATV-r should be used in children above 6 years and those weighing >25kg or more and adults
Patient Sensitization

• ATV-r is safe for use in pregnancy

• Ensure patients on ATV-r drink plenty of fluids to reduce the risk of kidney stones
• A common side effect associated with ATV-r is jaundice which is benign and in most cases, should resolve in a few weeks
• Jaundice from unconjugated hyperbilirubinaemia is largely a cosmetic issue and not related to hepatitis or liver
damage
• A liver function test, if available, should be conducted to help rule out other causes of jaundice
• If patient has symptomatic or profound jaundice, consult the UTH Advanced Treatment Centre
Contraindications

• Do not use ATV-r with Rifampicin-containing TB treatment. If patient is on ATV-r with no exposure to DTG in
First-Line and they develop TB replace ATV-r with DTG 50mg twice daily (see Figure )
• Do not use ATV-r with proton pump inhibitors (Omeprazole, Pantoprazole, Lansoprazole)
• Substitute PPIs (Omeprazole) with H2 receptor blockers (e.g. Cimetidine). It should be taken 2-3 hours apart with ATV-r
• Do not start patients with pre-existing jaundice or suspected hepatitis on ATV-r

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M ANAGEMENT OF P ATIENTS P REVIOUSLY ON ART
Individuals who interrupt ART for any reason are at increased risk of resistance and treatment failure. Management in ART re-initiation
is based on several factors, and a complete history to establish why the treatment was stopped is critical. For HIV-infected children, the
caregivers must be questioned.

• If treatment failure or toxicity is not suspected as the reason for stopping ART, and previous good adherence is reported,
reinitiate original ART in consultation with next level.

• If previous adherence is poor and there is treatment failure, these individuals (and caregivers of children) MUST be enrolled
in intensive adherence counselling sessions until there is agreement among the patient, provider, and adherence counsellor
that the patient is ready to commence Second-Line ART. Use of treatment supporters for such patients is strongly
recommended.

• If severe toxicity is the reason for stopping ART, refer to the next level and initiate ART using the appropriate drug
substitution and counsel regarding adherence.

• Viral load testing should be done 6 months after re-initiation of the original regimen to document HIV viral suppression.
• Do not collect viral load tests for patients who present to care while not taking ART

Management of Pregnant and breastfeeding women defaulters OR FAILING THERAPY

• Due to the risk of the transmission of HIV to the unborn or breastfeeding infant, pregnant or breastfeeding women who present
to care with unsuppressed viral load or who have defaulted treatment must be switched to an effective therapy (second-line if
they previously took a first-line or third-line if they previously took second-line) immediately while the EAC is in process. DTG
based regimens are recommended in this situation.

When to stop ART

Patients may choose to postpone or stop therapy, and providers, on a case-by-case basis, may elect to defer or stop therapy on the
basis of clinical and/or psychosocial factors.

The following are indications for stopping ART:

• Patient’s inability to tolerate all available ARV medications

• Patient’s request to stop after appropriate counselling
• Non-adherence despite repeated counselling: treatment should be stopped to avoid continued toxicity, continued evolution
of drug resistance, and transmitting drug resistant HIV
• Unreliable caregiver
• For children, the caregiver is instrumental in ART adherence. Any factors that affect the capability for the caregiver to give
medications consistently may be an indication to stop ART in an HIV-infected child.
• Serious drug toxicity or interactions
• Intervening illness or surgery that precludes oral intake
• ARV non-availability

How to stop ART

• Stop ALL the drugs when discontinuing therapy

• Discontinue EFV or NVP; continue the NRTI components (backbone) for 1-2 additional weeks
• Preventive measures, such as condom use and safer sex practices, should be strongly emphasized for all patients, especially
those discontinuing treatment

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Treatment Failure with No Further Treatment Options
Continue the failing ART regimen unless there are intolerable toxicities or drug interactions. Even with treatment failure, the
regimen is likely to have some residual antiviral activity. Stopping therapy in the setting of virological failure can be associated
with rapid falls in CD4 counts and development of OIs.

When to Consult or Refer to the Next Level

The following criteria are indications to consult or refer to the next level:

• Suspected hepatotoxicity not responding to standard management (e.g. TB/HIV co-infection treatment, ALT/AST >5-fold of
upper limit of normal)
• Second-Line treatment failure or inability to tolerate Second-Line therapy
• Complications on PI-based regimen
• Severe or life-threatening adverse reactions
• Inability to tolerate therapy despite change in regimen
• HIV-HBV co-infection with renal insufficiency

T HIRD-L INE ART: S ECOND -L INE TREATMENT F AILURE

Treatment failure is defined by a persistently detectable viral load >1,000 copies/mL. For adolescents and adults, failure is two
consecutive viral load measurements within a three-month interval, with adherence support between measurements after at least six
months of using triple combination ARV drugs. For children, viral load may still be detectable at 6-9 months after initiation and does
not necessarily mean treatment failure. Viral blips or intermittent low-level viremia (20–1,000 copies/mL) can occur during effective
treatment, but have not been associated with an increased risk of treatment failure unless low-level viremia is sustained. A repeat
blip should be assessed further at the ATC. Additionally, clinical and epidemiological studies show that the risk of HIV transmission
and disease progression is very low when the viral load is lower than 1,000 copies/mL
Provision of third-line ART occurs in very rare circumstances and is beyond the scope of most ART providers. All patients being
considered for third-line ART should have:

• Confirmed Second-Line ART failure (defined by a persistently detectable viral load exceeding 1,000 copies/mL [i.e.,
two consecutive viral load measurements within a three-month interval with enhanced adherence support between
measurements] after at least six months of using Second-Line ART)
• Genotype (resistance) testing (Figure 17) to an HIV Specialist at an Advanced Treatment Centre (ATC) with a complete ART
treatment history (i.e., all previous ARV drugs that the patient has taken with duration of use)
• Before starting third line, establish the reason for treatment failure (e.g., poor adherence, suboptimal dosing, drug-drug
interactions) and conduct intensive adherence counselling sessions until there is agreement between the patient, provider,
and adherence counselor that the patient is ready to commence third-line ART
• Use of treatment supporters for such patients is STRONGLY recommended

• The most likely ARVs to be successful in patients who have followed National Guidelines are Dolutegravir or Raltegravir
(Integrase inhibitor) or Darunavir with ritonavir (Protease inhibitor) plus optimal nucleoside background (e.g. TDF+XTC or
AZT+3TC)

Other considerations with major constraints:

• Etravirine: especially if genotype is available at time of 1st line NNRTI failure, although in some patients NNRTI mutations
persist even after non-exposure to NNRTIs in Second-Line
• Maraviroc: needs special tropism test before initiation, which is currently not available in Zambia

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Before switching therapy in suspected treatment failure, HCWs need to rule out:

• Poor adherence: change therapy only after enhanced adherence counselling has been conducted
• Immune Reconstitution Inflammatory Syndrome (IRIS): treat underlying condition and continue ART if tolerated
• Untreated OIs: treat underlying condition and continue ART if tolerated
• Pharmacokinetics (e.g. Rifampicin reduces NVP or LPV-r blood levels): switch NVP to EFV or double the dose of LPV-r
or switch Rifampicin to Rifabutin
o Current infections causing transient decrease in CD4 count: treat infection, and if possible, repeat CD4 one
month after resolution of illness to confirm immunologic failure

F I G U R E 17: I N F O R M A T I O N P A T H W A Y S FOR P A T I E N T S N E E D I N G ATC S E R V I C E S

MOH

PMO

ATC

DMO

Referral

Sample transportation (VL)

Facility
Results delivery

• MOH- Ministry of Health Reports – Feedback system

• ATC - Advanced Treatment Center PMO -
Results
Action –delivery
Feedback system
Provincial Medical Office
A
• DCMO - District Community Medical Office ATC e–referral c
t
i
o
n
F
e
e
d
b
a
c
k

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A
T
Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection C
e
N UTRITIONAL C ARE
Nutrition in HIV-Infected Children
Routine assessment is essential to identify malnutrition and growth faltering early. The following should be done for HIV-infected
infants and children:
• Assess nutritional status, diet, and symptoms at every visit
• Laboratory monitoring includes: total cholesterol, triglycerides, glucose, and Hb
• Assess WHO clinical stage, ask about history of recent diseases such as persistent diarrhoea or OIs (associated with
increased nutritional need), determine energy needs, and provide additional energy
• Measure weight and height at each visit and plot against national growth curves
o Normal growth
o Underweight (weight-for-age <3rd %)

o Stunted (height-for-age <3rd %)

o Wasted (weight-for-height <3rd %)

• If normal child growth, inform on healthy eating and avoidance of obesity
• If poor child growth
o Full dietary assessment is needed
o Assessment of drug adherence if the child is on ART
o Mothers or caregivers should be asked about food availability and food types offered to the child, as well as
who feeds the child, how much, and how often children should be examined for signs of OIs or wasting
o Provide appropriate clinical interventions (e.g., food support programmes)
• If severe malnutrition

o Stabilize the acute phase of malnutrition, similar to HIV-uninfected children with severe malnutrition, and
initiate ART soon after
o Immediately initiate ART if unexplained malnutrition (e.g., not associated with untreated opportunistic infection [OI])
and does not respond to standard nutritional therapy
o If unknown HIV status, test for HIV and consider ART initiation as needed
• If on ART, reassess frequently to adjust dose as needed. Recurrence of growth failure and severe malnutrition may
indicate treatment failure, poor ART adherence, or OIs.
Nutrition supplementation
• Give high-dose Vitamin A supplementation every 6 months for children 6 to < 60 months old
• Give Zinc supplementation for acute diarrhoea
• Mothers should exclusively breastfeed HIV-infected infants and young children for 6 months minimum and may continue up
to 2 years old

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Infant and Young Child Feeding
As a public health approach, all mothers should be encouraged to practice exclusive breastfeeding (EBF) for 6 months (Table 20).
EBF is defined as giving a baby only breast milk and no other liquids or solids, not even water unless medically indicated.
Thereafter, mothers should introduce nutritionally adequate complementary feeding while continuing breastfeeding up to at least 24
months old. Replacement feeding should only be considered if acceptable, feasible, affordable, sustainable, and safe (AFASS).

T A B L E 20: I N F A N T AND YOUNG CHILD FEEDING OPTIONS

Maternal Infant HIV Recommended Timing of Recommended Timing of

HIV status status Feeding Complementary feeding Complete Cessation of
Breastfeeding*
Exclusive breastfeeding After 6 months At 12 months if food security assured
Positive on Negative or
ART unknown (EBF) for 6 months Up to 2 years if food security
Replacement feeding not assured

Positive Positive EBF for 6 months Up to 2 years

Negative or Up to 2 years
N/A EBF for 6 months
unknown

*HIV-infected women should stop breastfeeding (at any time) gradually within one month.

Nutrition in HIV Infected Adolescents, Breastfeeding Women and Adults

• Calculate the body mass index (BMI) = weight/height2 to determine if the individual is underweight (<18.5kg/m2),
normal (18.5 to 24.9kg/m2), overweight (25 to 29.9kg/m2), or obese (≥30kg/m2)

• If BMI <16kg/m2 or anaemia (Hb <10g/dL) or has TB, refer for nutrition support programmes. Observe closely for
treatment complications, such as re-feeding syndrome, undiagnosed OIs, and IRIS

• If BMI >25kg/m2, provide nutrition counselling, including dietary advice and need for physical exercise

• Table 21 lists some of the specific BMI-related ARV drug risks

T A B L E 21: S P E C I F I C BMI-R E L A T E D ARV D R U G R I S K S

BMI ARV drug Associated Risks Recommended Actions

Tubular renal dysfunction
<1kg/m2 TDF
Fanconi syndrome
Lactic acidosis
Severe hepatomegaly with Manage these patients
AZT steatosis with caution. Consult next
level if necessary
Lactic acidosis
Severe hepatomegaly with
>25kg/m2 d4T
steatosis
Acute pancreatitis

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IMMUNE R ECONSTITUTION I NFLAMMATORY S YNDROME AND HIV
Immune reconstitution inflammatory syndrome (IRIS) is an exaggerated inflammatory reaction from a re-invigorated immune system
presenting as unmasking of previously sub-clinical opportunistic infections OR clinical deterioration of pre-existing opportunistic
infections OR development of autoimmune disease.
• Onset: usually within 2-12 weeks after starting ART
• Frequency: 10% among all patients on ART, up to 25% when ART initiated with CD4 < 50 cells/µL
• Risk factors:
• Initiating ART close to diagnosis of an opportunistic infection
o Initiating ART when CD4 is less than 50 cells/µL
o Rapid initial fall in HIV-1 RNA level in response to ART in patients with low CD4 counts
o Commonly seen with TB, cryptococcal disease, Kaposi’s sarcoma, and Mycobacterium avium complex
infection
o Patients initiated on DTG and with low CD4 counts have a higher risk of having IRIS

Management of IRIS

• Have high index of suspicion with early complications

• ART should be continued
• If ART continuation is impossible, temporarily interrupt the ART and restart same regimen after OI or IRIS is
addressed
• Diagnose and treat OI or inflammatory condition
• Corticosteroid treatment in moderate to severe cases: Prednisolone 0.5-1.0mg/kg/day for 5-10 days

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ART A DHERENCE

Recommendations

Strengthening adherence support interventions at the

Community Level

Enhanced Adherence Counselling (EAC) for ALL patients

with unsuppressed Viral Loads

Adherence to ART is important to achieve the goals of ART including viral load suppression. Poor adherence to ART is the most
important cause of unsuppressed viral load and treatment failure. Adherence assessment and messages must be given to recipient
of care during treatment preparation and at all visit whether in the community or at the health facility. This is because the readiness
and willing of patient to adhere to treatment changes over time.

E N H A N C E D A D H E R E N C E C OU N S E L I N G (EAC)

Enhanced Adherence Counseling (EAC) is a structured counseling intervention conducted on high viral load or unsuppressed patients
(VL≥ 1000 copies/mL) with the aim of resuppression (VL<1000 copies/mL). EAC explores the patients’ possible barriers to adherence
and identifies together with the patient a way forward. In Patients Living with HIV (PLHIV), VL is a direct indicator of viral replication.
Higher VL lead to greater fall in CD4 cell count. This increases the risk of morbidity, mortality and transmission of HIV infection to
others. Suppressing VL in PLHIV to less than 1000 copies/mL of blood is critical for reducing morbidity, mortality and HIV
transmission. The HPTN052 clinical trial has shown that viral suppression due to ART can reduce HIV transmission by up to 96%.

Poor adherence to ART is the most common reason for unsuppressed VL. Several studies have shown that about 30-60% of patient
treatment failures are as a result of poor adherence and clients are able to attain VL suppression after undergoing EAC with a trained
provider (Jobanputra, 2015; Patten, 2013). Several studies have shown that EAC leads to viral suppression in over 70% of patients
with high initial VL. World Health Organization (WHO) recommends EAC to address this problem. Good adherence to ART is critical
to achieving and sustaining among PLHIV. Barriers to adherence are categorized as follows; cognitive, socio-economic, behavioral
and psychological
How to Conduct EAC Sessions
The provider will schedule EAC sessions, preferably every two weeks or monthly and spread over a determine period. The number
and frequency of EAC sessions will be determined based on provider’s assessment and should be discussed with the patients and/or
treatment supporters. By case to case, less or more sessions might be required before the re-test viral load is done. These sessions
should provide an opportunity to administer a client-centered approach to identification of barriers and strategies to overcome them.
It is encouraged to involve other key stakeholders during the EAC sessions such treatment supporter (or buddy), Adherence Support
Workers (ASW), pharmacist, etc. It is important to obtain informed consent from the patient who should identify or choose the
treatment supporter.

Before the Session

The provider(s) must ensure that the following are in place:

§ Viral load results

§ EAC or high viral load register
§ Index register
§ Appointment or ART Tracking Register (where available)
§ Patient File
§ Conducive environment

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During Subsequent Sessions

§ Build rapport with patient: Introduce yourself, ensure patient is comfortable and reassure the patient on confidentiality.
§ Show your appreciation to the patient for coming back to the facility.
§ Verify and confirm the contact details viral load results for the patient.
§ Help patient identify and decide who in their social network may be available to provide immediate support
§ Explain to the patient the meaning of “good adherence” and its’ benefits such as reduction of viral load to undetectable level
and sustained for a longer period, restoration of immune system, “reduction” or elimination of HIV transmission’s risk,
improvement of quality of life, reduction of risk of HIV related infection (also called Opportunistic Infections)
§ Always verify the following:
o Is your patient taking the correct drugs (ARVs)? And is he/she taking any other medication or herbal remedies? (drug-
drug interaction)
o Is your patient taking the correct dose?
o Is your patient taking ARVs in the correct frequency?
o Is your patient taking ARVs at same time through out?
o Is your patient skipping or maintaining appointment?
o Is your patient sharing drugs (ARVs) with anyone?
o Or does your patient have any specific challenges you need to know (e.g. alcohol abuse, disclosure, etc.)?
§ EAC sessions should be focused on any adherence barrier or gaps identified
§ Explain to the patient the meaning of undetected and/or suppressed viral load. Remember to discuss the concept of U=U
(Undetectable = Untransmissible)
§ Explain to the patient the meaning of high VL result and the negative impact of the above VL result
§ Help patient cope with emotions arising.
§ Encourage and provide time for the patient to ask questions and discuss their concerns.
§ Make an active referral to community structures (CBOs) for psychosocial support.
§ Provide additional referrals for prevention, counselling, support and other services as appropriate (e.g. mental health services,
family planning, ANC, nutritional and TB screening).

End of the Session

§ Discuss any further questions or concerns that the patient may have.
§ Schedule follow-up visit suitable for both patient and healthcare provider.
§ Write the date of the follow-up visit in patient’s appointment card.
§ Remind the patient that they shall be followed up through phone or home visit if they miss appointments and obtain consent for
patient to be followed.
§ Provide relevant IEC materials.
§ Provide hope and encouragement to the patient.

§ The re-test VL should be done within 3 months of good adherence which will be demonstrated by VL resuppression.

Undetectable=Untransmittable

§ Scientific evidence shows that an HIV positive individual who has an undetectable viral load is incapable of transmitting the HIV
virus. This evidence should be used as an incentive to encourage recipient of care on treatment to adhere to the treatment so
that they can reach the undetectable status.
§ In this regard, HIV discordant couples in need of conception could engage in condomless sex for the purposes of conception.
However, the message of U=U must be applied with all other HIV preventative methods such as PrEP, Condoms and Abstinance

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F I G U R E 18: B A R R I E R S TO ADHERENCE

Barrier Solutions Barriers Solutions

Knowledge • Providing IEC Life conditions Link to family,
materials. skills
Information Degree of social
• One on one and support strengthening and
Perception group counselling. social welfare
• Peer to peer Stigmatization programs
Motivation support Financial

Cognitive Socio-economic

Behavioral Emotional

Barriers Solutions
Barriers Solutions
Skills Education on HIV
Depression Screen for and
Routines Personalized treat mental
Anxiety
adherence plan illness
e.g alarms
Habits e.g Behavior change
Alcohol, drugs
and tobacco

EAC must still be done on all recipients of care with a Viral Load > 1000 copies/mL. A minimum of 3 sessions must be given and a
repeat Viral load must be done at the end with an appropriate intervention to the Viral Load test at the end.

F I G U R E 19: P R O C E S S OF E N H A N C E D A D H E R E N C E C O U N S E L L I N G (EAC)

Identify clients who need

Session One Session two Session three Repeat VL
EAC

Explain the importance of Explain the importance of Repeat VL after 3months

VL > 1000 cp/mL Introduction creat rapport
adherence adherence after the previous test
Assess understianding of Asess understanding of the switch the regimen if
Explain VL results the first session second session VL>1000 cp/mL
On tretatment >6 montha
Educate on treatment failure keep on same regimen if
Explore barriers educate on treatment failure
and 2nd/3rd line treatment VL<1000 cp/mL
Support to make support personalised
Find strategies aherence plans
personalised adherence plan
Creat adherence plan Explain way forward

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Summary of Key Points under ART Adherence

Provider-Related Strategies to Improve Adherence

• Establish trust and make sure the patient feels you are there to help manage and solve problems
o Involve the patient in developing a plan for taking the drugs that is simple and works with the patient’s daily
activities
o Educate about goals of therapy, side effects, what will happen if the patient does not take all the drugs
• Treat depression or substance abuse issues
• Treat and manage side-effects
• Monitor adherence at each visit
• Reinforce importance of adherence at each follow-up visit

Ensure patients identify treatment supporters with whom they are comfortable (e.g., family members, buddies) and encourage
treatment supporters to attend counselling sessions and clinic visits

Structured treatment preparation before ART initiation (Table 10 and Figure 10) should be conducted for all patients for
successful HIV treatment and care. Take note that ART can be initiated during any of these sessions (all patients should be fast-
tracked after looking at safety and also readiness):
• Session 1: Enrolment and Assessment, HIV education and ART initiation
• Session 2: ART support, preparation and ART initiation
• Session 3: ART education, preparation, and ART initiation

Adherence assessment should be done by all members of the healthcare team using:
• Clinical and laboratory parameters
• Patient reports
• Pill counts
• Pharmacy pick-ups
• Other tools of adherence

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R ETENTION TO C ARE

Recommendations

Lost to Follow-up at 30 days

Assignment of an appointment System Manager

Immediate acommencement of tracing of Missed appointment

patients

Screening for TB/OIs at Return to Care

Tracking and Keeping Patients in Care

Keeping patients in care is essential for achieving good outcomes and preventing resistance. Lost to follow up (LTFU), defaulting and
late drug pick-ups may lead to treatment failure, emergence of resistance, and the possibility of transmitting resistant virus. Health
facilities should aim to do the following to minimize LTFU:

• Have a structured plan to track patients and prevent LTFU

• Monitor all missed clinic and pharmacy visits
• Create linkages with home-based care workers and volunteers
• Dedicate health facility staff to ensure patients who miss visits are contacted

Attrition

Attrition in an HIV programme can occur as the following: late, LTFU, defaulter, death, transferred out to another facility, or unknown
status.

• Late: HIV-infected individual misses a scheduled pharmacy refill visit,

o Take immediate action (e.g., CHW follow up, text message or mobile health [mHealth] follow up) within 24 hours and
document findings. Every effort must be made to re-engage these women in care
• LTFU: HIV-infected individual is missing for ≥30 days after missed pharmacy refill visit after all active tracking interventions
(e.g., documented physical follow-up to home, phone calls to client and emergency contacts, text message recall, treatment
buddy) have been exhausted and HIV-infected individual cannot be traced
o For pregnant and breastfeeding women, LTFU is defined as missing for ≥30 days after last scheduled pharmacy refill visit
with inability to be traced after all active tracking mechanisms have been exhausted.
• Defaulter: HIV-infected individual has been located while late or LTFU, but chooses not to return to care.
• Unknown status: all active tracking interventions have not been exhaustively done to determine current status of HIV-infected
individual (for ≥30 days), see Figure 20 below.

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F I G U R E 20: A L G O R I T H M F O R A C T I V E I N T E R V E N T I O N S WHEN HIV-I N F E C T E D C L I E N T S ARE LATE AND
DETERMINING THEIR ATTRITION STATUS

Patient misses a pharmacy refill appointment

Designate patient as LATE

Health facility must document the following clearly:
• Method of reconciling late clinic and pharmacy appointments for clients by number of days
• Active tracking interventions employed
• Feedback from tracking interventions documented in chart

Active tracking interventions

• Text message to client

• Phone call to client
• Home visit to client
• Contact with community worker or home base care agency
• Text message or phone contact with treatment buddy or emergency contact
• Track patient as soon as he/she has missed a pharmacy refill appointment up to 30 days

UNKNOWN STATUS TRANSFERRED OUT DEFAULTER LOST TO FOLLOW UP

or DEAD • Tracking intervention
• No tracking • Tracking
intervention done • Tracking intervention intervention done done repeatedly
done • Results of tracking • Results of tracking
• Results of tracking intervention: client intervention: client not
intervention: client refuses or is unable found after 30 days
transferred to another to come back to
facility or is dead health facility

Structured Facility HIV Appointment System

A missed appointment is a first step of a patient fall-out of care. Therefore, all ART centres must have a dedicated individual to
manage the appointment system. Ideally, a list of scheduled appointments should be prepared a few days before the scheduled
appointments and patients must be reminded to come for their appointments. Those who miss appointments should be tracked should
as soon as possible.

Each day that elapses after missed appointment could be a day without ART, and increasing the likelihood of resistance development
and treatment failure. Scheduling patients for appointments and reviewing the list of patients expected on a given day is critical to
tracking patients’ missed appointments. All patients who are tracked must be documented in the community ART register or
equivalent, including the outcome of the tracking process.

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CO-MORBIDITIES

Recommendations

ART should be started in all TB patients living with HIV regardless

of CD4 count

Xpert MTB/RIF is the preferred diagnostic test for HIV associated

TB

Assessment and management of Cardiovascular Diseases (CVDs)

in all HIV patients

Oral-based DR-TB Treatment Regimen

T UBERCULOSIS A ND HIV
There is a high incidence of TB among HIV-infected persons. According to the WHO TB REPORT, 2017, about 10.4 million
people fell ill with TB in 2016 and 10% of these were co-infected with HIV. Therefore, with such high numbers, all
HIV-infected individuals should be screened for TB and placed on TB treatment if found with TB. HIV-infected individuals with TB
should begin anti-tuberculosis therapy (ATT) via directly observed therapy, short course (DOTS) as per National TB Guidelines.
Persons who screen negative for TB should be given TB INH Preventive Therapy (TB-IPT).

Screening for Active Tuberculosis

F I G U R E 21: TB S C R E E N I N G A L G O R I T H M

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Diagnostic Tools and Tests for TB

Tools and tests used for TB diagnosis provide either a definitive diagnosis (bacteriological confirmation of TB) or supportive
information to aid diagnosis of tuberculosis.

Key Messages
o Xpert MTB/RIF is recommended as the initial diagnostic test in all presumptive TB patients
o Smear microscopy may continue being the initial test in settings where Xpert MTB/RIF is not yet available
o Smear microscopy --- and NOT Xpert MTB/RIF --- should be used for treatment monitoring
o All TB retreatment patients tested RIF negative on Xpert MTB/RIF should have FL LPA, Culture and DST
o All DR-TB and RIF positive on Xpert MTB/RIF patients should be tested with SL LPA, Culture and DST
o A negative laboratory test (i.e. smear, Xpert MTB/RIF, LPA and/or culture) in the setting of a TB-compatible
clinical presentation does NOT definitively rule out TB. Such patients should be clinically evaluated for TB.
o Patients with strong clinical evidence of TB (especially PLHIV, Children, EPTB) should start TB treatment
even if bacteriological tests are negative or not available (clinically diagnosed TB)

Bacteriological Tests for TB Diagnoses

Xpert MTB/RIF

Xpert MTB/RIF test * is a fully automated real time PCR based (molecular) test, disposable, ARTridge-based nucleic acid
amplification test.

• Highly sensitive and specific, more sensitive than smear microscopy.

• Rapid and simultaneous detection of tuberculosis and Rifampicin resistance (a reliable proxy for MDR-TB).

• Results are available within 2 hours.

• Xpert MTB/RIF should not be used for follow up (use smear microscopy instead).

• Collect one spot specimen (3-5 mL).

• Submit the specimen as soon as possible for testing. Samples must be stored at 2-8°C for maximum of 5 days or at room
temperature for a maximum of 3 days if testing cannot be done on the same day.

• Xpert MTB/RIF is recommended as the first diagnostic test in all adults and children with signs and symptoms of TB where
available (Figure 21).

• If not available, the samples from Priority* patients should be referred to facilities with GeneXpert machines (PLHIV,
Children, EPTB, risk of DR-TB, HCW, miners, prisoners).

Limitations:

• Does not detect resistance to Isoniazid or other first- or Second-Line anti-tuberculosis medications.
• Cannot be used for treatment monitoring (may remain positive even after treatment kills the bacteria because it detects TB
DNA and not live bacteria).

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 X P E R T MTB RIF M A C H I N E Xpert MTB RIF ARTridge

Reporting Xpert MTB RIF Results

Reporting Xpert positive results must also include the results from Rifampicin resistance testing
o MTB detected, RR+ve (MTB detected with Rifampicin resistance detected)
o MTB Detected, RR-ve (MTB detected with no Rifampicin resistance detected)
o MTB detected, RRI (MTB detected Rifampicin resistance indeterminate)

Xpert Negative results must be reported:

o MTB not detected
In rare cases, where the only result that is available for Xpert MTB RIF is error, invalid or no result- this result
should be captured as below and a repeat sample collected for testing:
o Err, Inv, No result

*Operational problems associated with this test include: the shelf-life of the ARTridges is only 18 months, a very stable
electricity supply is required, the machine needs to be calibrated annually, and the temperature ceiling is critical
Smear Microscopy
Smear microscopy is the first diagnostic test in facilities where Xpert MTB/RIF is not available. Smear microscopy is recommended
to monitor treatment response (follow up). Results should be reported according to Tables 22-23.

Two spot specimens should be collected for smear microscopy at the time of request (at least 15 to 30 minutes apart).

Should be used for treatment monitoring.

LED microscopy has a sensitivity gain of 10% over ZN and should be used in place of ZN.

The results of positive sputum examination should be recorded in red ink in the register for easy identification.

Sputum results must be reported within 24 hours.

Limitations:

It is often negative in PLHIV, children and EPTB samples and cannot detect rifampin resistance.

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 Key Message

Sputum smear microscopy should only be used for diagnosis where Xpert MTB RIF is not accessible
and in such an instance, ensure sample is sent for Xpert at the nearest centre

LED M I C R O S C O P E ACID FAST BACILLI

The following WHO recommended method of reporting of smear microscopy results should be used.
T A B L E 22: R E P O R T I N G FOR F L U O R E S C E N C E M I C R O S C O P Y (FM) R E S U L T S

200x 400x Result Reported

No AFB in one length No AFB in one length No AFB Seen

1– 4 AFB in one length 1 – 2 AFB in one length Report actual number *

5 – 49 AFB in one length 3 – 24 AFB in one length Scanty Positive

3 – 24 in one field 1 – 6 AFB in one field 1+

25 – 250 AFB in one field 7 – 60 AFB in one field 2+

>250 AFB in one field >60 AFB in one field 3+

*Confirmation required by another technician or prepare another smear, stain and read. Report as positive (actual
number only if the result is confirmed by a second reader of a repeat smear)

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T A B L E 23: R E P O R T I N G OF Z I E H L –N E E L S E N (ZN) R E S U L T S

Number of bacilli seen in smear Results Result Reported

No AFB in 100 fields Negative No AFB Seen

1 – 9 AFB in 100 fields Positive Record exact number of bacilli

10 – 99 AFB in 100 fields Positive 1+

1 – 10 AFB per field, check 50 fields Positive 2+

>10 AFB per field, check 20 fields Positive 3+

Line Probe Assay (LPA)

LPA is based on polymerase chain reaction (PCR) and the DNA strip technology. LPA does not eliminate the need for
conventional culture and phenotypic drug susceptibility testing. LPA is available in Zambia at referral Mycobacterial culture
laboratories. Line Probe Assay can be performed directly using a processed sputum sample or indirectly using DNA isolated and
amplified from a culture of M. tuberculosis.

First-Line LPA is recommended for the rapid detection of resistance to rifampicin and isoniazid in sputum specimens and cultures
of Mycobacterium tuberculosis. It is recommended on DR –TB suspected patients with MTB detected and RIF negative on Xpert.

Second-Line drugs Line probe assay (SL LPA) is recommended for patients with confirmed Rifampicin resistance (RR-TB) or multi
drug resistant tuberculosis (MDR-TB);

T A B L E 24: I N T E R P R E T A T I O N OF RESULTS FOR LPA

Result Interpretation

MTB was isolated from the specimen therefore the patient has
MTB complex detected
bacteriologically confirmed TB

MTB complex not detected MTB was not isolated from the specimen

Rifampicin and Isoniazid susceptible Patient has drug susceptible TB

Rifampicin and Isoniazid resistant Patient has multi drug resistant TB (MDR-TB)

Rifampicin resistant and Isoniazid

Patient has Rifampicin resistance (RR-TB)
susceptible*

Rifampicin susceptible and Isoniazid

Patient has Isoniazid resistance
resistant

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Mycobacterial Culture
Culture is the gold standard for TB Diagnosis.

• Highly sensitive and specific method.

• There are two culture methods available, namely solid and liquid. If liquid culture is used, sensitivity gain is +10%
compared with Löwenstein-Jensen solid culture.
• Refrigerate culture specimens at 2-8°C until ready for transport to the laboratory.
• If a refrigerator is not available, specimens must be held in coolers with ice packs.
• Specimens must be delivered as soon as possible, but no later than 48 hours from time of collection.

Limitations:

• Long turnaround time of the results (Liquid 21 days, Solid 48 days to inform a negative result)
• Expensive

Positive Liquid Culture Positive LJ Culture Genotype Results

Culture is recommended for:

• All previously treated TB patients (loss to follow up, retreatment, failure)

• Smear-positive after 2 months of First-Line treatment
• Drug resistant TB contacts
• RR TB patients by Xpert MTB/RIF
• Patients who develop active PTB during or after IPT
• Healthcare worker, miners, prisoners
• Extra-pulmonary specimens
• Specimens from Children
• Diagnostic uncertainty

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T A B L E 25: I N T E R P R E T A T I O N OF RESULTS FOR CULTURE

Result Meaning

Mycobacterium tuberculosis isolated Positive

Mycobacterium tuberculosis not

Negative
isolated

Contaminated Specimen not properly handled (repeat specimen collection)

The test was not performed due to many reasons such leaked specimen,
Not Done mismatch information on the sample and request form and insufficient specimen
etc.

Mycobacteria’s other than

Non-Tuberculous Mycobacterium (NTM) which may or may not be clinically
Mycobacterium tuberculosis isolated
significant
(MOTT)

Notes: A practical description of all the procedures for sputum smear microscopy, culture and DST and Xpert
MTB/RIF are detailed in the relevant TB laboratory Manuals.

Phenotypic Drug Susceptibility Test (DST)

Phenotypic, culture methods are based on assessment of the ability of M. tuberculosis to grow in culture media (solid or liquid)
containing a critical concentration of specific anti-TB agents (which indicates resistance) or, conversely, its inability to grow in the
same media (which indicates susceptibility).

• Phenotypic DST for First-Line agents (Isoniazid, Rifampicin Ethambutol and

Streptomycin), and selected Second-Line anti-TB drugs (Kanamycin, Amikacin,
Ofloxacin, Levofloxacin) is generally reliable and reproducible.

• Other anti-TB agents such as the later generation fluoroquinolones (Moxifloxacin and
Gatifloxacin), Capreomycin, Thioamides, Cycloserine and Pyrazinamide are
becoming increasingly important in the treatment of DR-TB and there is a need for
their critical concentrations to be re-evaluated

• DST methods for new and repurposed drugs for the treatment of MDR-TB such as Bedaquiline, Delamanid, Linezolid,
Clofazimine need validation.

Lateral Flow Urine Lipoarabinomannan (LF-LAM)

• Tests based on the detection of LAM antigen in urine. LAM antigen is released from metabolically active or degenerating
bacteria.
• A positive result is diagnostic of active TB disease
• A negative result does not rule out TB
• Urine is easy to collect and the test can be performed at bed side, and lacks the infection control risks associated with
sputum collection.
• In in-patient settings, it is recommended to use LF-LAM to assist the diagnosis of active TB in HIV-positive adults,
adolescent and children with signs and symptoms of TB, or with advanced HIV or who are seriously ill or else irrespective
of signs and symptoms of TB and a CD4 count < 200 cells/mm3

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 • In out-patient settings. LF-LAM can be used to assist in the diagnosis of active TB in in HIV-positive adults, adolescents
and children: with signs and symptoms of TB or seriously ill; or else irrespective of signs and symptoms of TB and with a
CD4 count of < 100 cells/mm3
• In out-patient settings, LF-LAM should not be used to assist the diagnosis of active TB in HIV-positive adults, adolescnets
and children without assessing TB symptoms; or without symptoms and unknown CD4 count; or else without TB
symptoms and CD4 count ≥ 100 cells/mm3

Evaluating Patients for TB

F I G U R E 22: X P E R T MTB RIF A L G O R I T H M

1
All Presumptive TB

Collect 1 spot sample for Xpert MTB/RIF

(Sputum, CSF & Aspirates)

MTB detected, MTB detected, MTB detected, RR MTB not No results,

RR not RR detected indeterminate detected error or invalid
detected result

Treat with nd
Repeat
• Treat with 2 line • Treatment with
First-Line Xpert
2 regimen First-Line • Do CXR and broad 4
regimen regimen spectrum antibiotics MTB/RIF
• Send two
specimens for SL • Repeat Xpert for at least 7 days
3
LPA and MTB/RIF • If CXR is suggestive,
culture/DST treat for TB
• Adjust the • If CXR is not
treatment according suggestive, re-
to DST result when evaluate
available

1
For PLHIV who have CD4 counts ≤100 cells/μL or are seriously ill with one or more danger signs, a urine LF-LAM assay may also be used if
available.
2
Patients should be initiated on a First-Line regimen. A sample may be sent for First-Line LPA and culture/phenotypic DST if
there is a risk of DR-TB:
• Previously treated TB patients: loss to follow up, retreatment, failure
• DR-TB contacts
• Smear positive at month 2 of First-Line treatment
• Healthcare worker
• Miners
• Prisoners
If patient has high risk of DR TB as a contact of a DR TB patient and patient is failing First-Line treatment, start Second-Line treatment while
waiting DST results
3
Treat the patient according to result of the repeat test. If the second Xpert MTB/RIF is negative, continue the First-Line TB
treatment and send specimen for FL LPA, culture and phenotypic DST
Note that FL-LPA is recommended for use with smear-positive sputum samples only.
4
Treat the patient according to result of the repeat test.

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Error! Reference source not found. is an interim algorithm in facilities where Xpert MTB/RIF is not yet available for all presumptive T
B patients but is only available for priority populations, and smear microscopy is used for other patients.
HCW need to assess carefully the patients and ensure that all the priority patients (i.e. PLHIV, children, EPTB and patient with risk
of DR-TB) collect and send samples to a facility where Xpert MTB/RIF is available.

HCW should decide the treatment of the patients without waiting for Xpert MTB/RIF results (as it can be delayed). Consider the
possibility of clinically defined TB (i.e., no bacteriological confirmation). Use clinical judgement for treatment decisions. When the
Xpert MTB/RIF result is available, treatment can be adjusted accordingly.

F I G U R E 23: A L G O R I T H M OF SPUTUM SMEAR PLUS PRIORITY PATIENTS FOR X P E R T MTB/RIF T E S T I N G

(FOR FACILITIES WITHOUT X P E R T M T B /R I F A C C )

1
All Presumptive TB

Evaluate the patient for TB, HIV and

DR-TB risk factors

Priority patients for Xpert MTB/RIF testing: Other patient categories

• PLHIV
• Children (0-14 years)
• EPTB samples Collect 2 sputum samples
• Previously treated TB patients (loss to follow up, relapse, failure) • Perform 2 sputum smears
• DR-TB contacts
• Smear positive at month 2 of First-Line treatment
• Healthcare worker, miners, prisoners Both smear One or both
negative smear positive

Collect 3 samples:
Perform 2 smear microscopy on site
Treat with
Refer 1 specimen for Xpert MTB/RIF (don’t wait for the result) First-Line
regimen
• Re-evaluate the
Smear Smear patient clinically
Positive Negative • Conduct
additional testing
• Send specimen for
Treat with First-Line Re-evaluate the patient Xpert MTB/RIF
Regimen clinically • Use clinical
judgment to
If patient has very High • Conduct additional decide treatment
risk of DR TB as Contact testing (eg. CXR)
of DR-TB patients and • Use clinical judgment for
patients failing first line treatment decisions
treatment start Second-
Line treatment while
waiting DST Results

Review the treatment Review the clinical

based on Xpert MTB/RIF decisions based on Xpert
result MTB/RIF result

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T UBERCULOSIS T REATMENT AND M ANAGEMENT

Key Messages

• First Line treatment (previously Category I) remains the same: 2 RHEZ/4 RH

• TB meningitis and Osteoarticular/spine TB are treated for 12 months (2RHEZ/10 RH)
• Category II treatment (2SRHEZ/1RHEZ/5RHE) should no longer be prescribed
• All previously treated patients should have their samples sent for Xpert MTB/RIF, First-Line LPA, Culture
and phenotypic DST to guide the treatment. Start first line treatment while awaiting the results.
• All DR TB contacts with a diagnosis of TB should start Second-Line treatment while awaiting the DST
Results
• Patients failing first line treatment should start Second-Line treatment while awaiting the DST results
• Patients diagnosed with TB and are HIV infected should initiate ART within 2-3 weeks once TB treatment is
tolerated. In cases of TB Meningitis, TB therapy should be delayed until after 8 weeks on TB therapy

Aims and Principles of TB Treatment

Early case finding and adequate treatment of tuberculosis using DOTS is the cornerstone of TB control.
The aims of treatment are:
• To cure patients and restore their quality of life and productivity
• To prevent further transmission of TB in the community
• To prevent relapse
• To prevent death from active TB or its late effects and complications
• To prevent the development of drug resistance—including MDR-TB and XDR-TB

The Principles of TB Treatment are:

• TB treatment involves use of correct doses of multiple drugs to ensure effectiveness of therapy
• Never add a single drug to a failing regimen
• At no time should monotherapy (use of a single anti-TB drug) be employed as treatment for active TB
• TB drugs should be taken daily for a specified period depending on the severity of the disease

Essential Anti-TB Medicines

The recommended essential First-Line anti-TB medicines are Rifampicin (R), Isoniazid (H), Ethambutol (E) and Pyrazinamide (Z).
Fixed dose combination (FDC) is preferred over single drug formulation. The fixed dose combinations are 4FDC (RHZE) and 2FDC
(RH). Drug dosage is based on weight. Monitoring the patient’s weight is essential for proper dosing.

Key Message

• TB medicines are available free of charge

• It is essential that all facilities treating TB patients stock single formulation drugs for use when
necessary, especially in an event of side effects
•

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Properties of Anti-Tuberculous Drugs
T A B L E 26: P R O P E R T I E S O F F I R S T -L I N E TB D R U G S

Drug Drug Property Target Bacilli Site of Action

Bactericidal within 1 hour. High potency. All populations including Intracellular and
Rifampicin
Most effective sterilizing drug dormant bacilli extracellular

Bactericidal after 24 hours.

Rapid and intermediate Intracellular and
Isoniazid High potency: kills>90% bacilli in the first few days
growing bacilli extracellular
of treatment
Bacteriostatic. Low potency. Minimizes the Intracellular and
Ethambutol All bacterial populations
emergence of drug resistance extracellular
Bactericidal with a low potency. Achieves its Intracellular bacilli in
Pyrazinamide Slow growing bacilli
sterilizing action within 2-3 months macrophages

Standardized First-Line Treatment

A standardized treatment regimen has been adopted comprising the 4FDCs (RHZE) and 2FDC (RH) for a period of 6-12 months
depending on the severity and anatomical location of the disease

Intensive Phase Continuation Phase

• Designed for the rapid killing of actively growing and • Eliminates bacilli that are still multiplying and
semi-dormant bacilli. reduces the risk of failure and relapse.
• Achieves a shorter duration of infectiousness. • The duration is for at least four (4) months in most
• The duration of the phase is two (2) months in new cases and ten (10)* months if the patient has
and retreatment cases. meningitis, Osteoarticular or spinal TB.

*It is recommended to extend treatment to 12 months for TB meningitis because of serious risk of disability and mortality and
Osteoarticular /spinal TB because of difficulties of assessing response to treatment.
T A B L E 27: R E C O M M E N D E D R E G I M E N S

TB disease category Recommended Regimen

Treatment Phase Intensive Phase Continuation Phase

All forms of TB (non-severe) 2RHZE 4RH

TB Meningitis, Osteoarticular and Spinal TB
2RHZE 10RH
(severe forms)

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T A B L E 28: W E I G H T B A N D S FOR DOSING OF A N T I -TB D R U G S

Body Weight (Kg) Intensive Phase (RHZE 150/75/400/275) Continuation Phase (RH 150/75)

25-37 2 2

38-54 3 3
55-70 4 4
Above 71 5 5

Key Message
Dosing for all patients should be according to weight and adjusted according to close weight monitoring

TB Treatment of New and Previously Treated Patients

• Treat all new TB patients (bacteriologically confirmed, clinically diagnosed and extra-pulmonary TB) with First-Line TB
drugs with the exception of the new patients who are confirmed DR-TB patients
• For patients with a known DR-TB contact, a Second-Line regimen based on the DST of the presumed index case should
be started while awaiting DST results
• In previously treated patients, send samples for Xpert MTB/RIF, First-Line LPA, Culture and phenotypic DST. Start
First-Line treatment while waiting for the results
• For patients failing First-Line regimen, send samples for Xpert MTB/RIF, First-Line LPA and culture. Start Second-Line
regimen while waiting for the results. Adjust the therapy once DST results are available

Standard Indications of Steroids in the Treatment of Tuberculosis

• TB meningitis • Massive Pleural effusion

• Constrictive TB pericarditis with suspected • Massive lymphadenopathy with pressure effects
constrictive physiology • Severe hypersensitivity reactions to anti-TB drugs
• TB IRIS
Other Possible Indications for Steroids in the Treatment of Tuberculosis:

• Hypoadrenalism
• Renal tract TB (to prevent ureteric scarring)
• TB laryngitis with life threatening airway obstruction

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Recommended Doses of Adjuvant Steroid Therapy

T A B L E 29: R E C O M M E N D E D D O S E S OF A D J U V A N T S T E R O I D T H E R A P Y (D R U G OF CHOICE IS
PREDNISOLONE)

Indication Prednisolone (Dosage)

TB Meningitis 1-2mg/kg (max 60mg) for 2 weeks then taper off by 10 mg in the daily dose
each week over about 6 weeks

1-2mg (max 60mg for 4 weeks then half for 4 weeks (max 30mg/day) then 15
TB Pericarditis
mg/day x 2 weeks, then 5 mg/kg x 1 week, then off

TB Pleural effusion (severe) /or

0.5 to 1mg (max 30mg) for 1-2 weeks then taper off over several weeks
IRIS

Note: Steroids doses must not be stopped abruptly, but must be tapered. If prednisolone is unavailable,
equivalent doses of dexamethasone may be used as a substitute.

Key Message

Steroids are immunosuppressant and may theoretically increase the risk of developing opportunistic infections in
TB/HIV patients. However, used as indicated above, the overall benefit of steroid use outweighs the potential risk.

TB Patients Monitoring and Follow-Up

• All TB patients must be seen at least once monthly by a healthcare provider for clinical review, assessment of side
effects and dose adjustment according to weight.
• All patients should have 1 sputum specimen (morning) taken for AFB smear at 2, 5 and 6 months. If sputum smear is
positive at 2 months, proceed to continuation phase and send sputum specimens for Xpert MTB/RIF, First line LPA,
culture and phenotypic DST.
• Repeat smear microscopy at month 3. If sputum smear is still positive at month 3, send samples for Xpert MTB/RIF,
First-Line LPA, culture and phenotypic DST (continue or adjust the treatment according to the results). Results should
be available at these visits and must be recorded on the patient treatment card and registers.

Key Messages

1. If a patient is found to have a drug resistant strain of TB at any time during the therapy, treatment is
declared as failed and patient referred for DR-TB treatment and re-register as such

2. For previously treated TB patients, specimens for Xpert MTB/RIF, LPA, culture and phenotypic DST
should be sent before starting treatment (DST should be performed for at least Rifampicin and
Isoniazid, WHO 2017)

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T A B L E 30: S U M M A R Y OF SPUTUM MONITORING BY SMEAR IN F I R S T -L I N E T R E A T M E N T

Treatment Months of
Sputum Smear Exam
Phase Treatment

1
Intensive Phase

2 If smear positive, send sample for LPA, culture and DST

If smear was positive at month 2, repeat smear at month 3. Send samples for
3 culture, LPA and DST if still positive; ensure samples are received at the
laboratory.

4
Continuation
Phase
If smear positive, obtain samples for LPA, Culture and DST. If there is concern
5
for MDR-TB, send sample for Xpert MTB/RIF to assess for rifampin resistance.

If smear negative, assign appropriate treatment outcome.

6
If positive, obtain samples for LPA, Culture and DST.

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T A B L E 31: HIV-TB C O - I N F E C T I O N C A S E S C E N A R I O S AND RECOMMENDED MANAGEMENT FOR
S U S C E P T I B L E TB

Scenario TB management Recommended ART

Continue EFV-based ART

Pregnant, on ART
Start ATT immediately Evaluate for failure and consider switching to 2nd line ART in
and develops TB
consultation with next level
Pregnant, on ATT,
Start ART immediately TDF + XTC + EFV-400mg If
and diagnosed Continue ATT
renal insufficiency, ABC + 3TC + EFV
with HIV
Children 3 months
Start ATT (RHEZ)
to <3 years old with ABC + 3TC + EFV
immediately
TB-HIV co-infection
Start ART as soon as ATT is tolerated (usually within 2-3 weeks)
Newly diagnosed regardless of CD4 count or WHO Clinical Staging
TB and HIV co- Start ATT TDF + XTC + EFV-400mg. If it cannot be tolerated, give:
infection immediately TDF + XTC + DTG* (DTG 50mg twice daily if single DTG tablet is
TB retreatment available). If not available or cannot be tolerated, give:
case and HIV TDF + XTC + LPV-r (Increase LPV-r from 2 tabs BD to 3 tabs BD for 2
co-infection weeks and then to 4 tabs BD for the remainder of TB treatment)
If renal insufficiency, ABC + 3TC + DTG 50mg twice daily
If NVP-based regimen, switch NVP to EFV-400mg. If cannot be
tolerated switch to DTG* 50mg twice daily and continue ART
On ART and Start ATT If on ATV-r, switch to LPV-r and double the dose
develops TB immediately If on LPV-r, double dose of LPV-r
Evaluate for failure and consider switching to 2nd line ART in
consultation with next level
Start ART as soon as ATT is tolerated (usually within 2-3 weeks*),
regardless of CD4 count or WHO clinical staging

TDF + XTC + EFV-400mg

On ATT and
diagnosed with Continue ATT TDF + XTC + DTG (DTG 50mg twice daily if single DTG tablet is
HIV available). If not available, give:

TDF + XTC + LPV-r (Increase LPV-r from 2 tabs BD to 3 tabs BD for 2

weeks and then to 4 tabs BD for the remainder of TB treatment)
If renal insufficiency, ABC + 3TC + EFV

On 2nd line ART Start ATT per Increase LPV-r from 2 tabs BD to 3 tabs BD for 2 weeks and then to 4
with LPV-r and guidelines tabs BD for the remainder of TB treatment. If Rifabutin available (in
develops TB immediately place of Rifampicin), start at 150mg Monday/Wednesday/Friday

• Patients on TB treatment should be initiated on TDF + XTC + DTG. Take note that DTG in this case should be given as 50mg
twice daily.
• For treatment experienced patients on DTG who develops TB and DTG single tablet is not available: Switch to
TDF+XTC+EFV-400mg if viral load <20 copies/mL, and TDF+XTC+LPV-r if viral load > 20 copies/mL
• REMEMBER to switch back to DTG 50mg once daily and LPV-r 2 tabs twice daily after TB treatment!
• Patients on ART on TAF who develop TB, should be switched to TDF
• HIV-positive TB patients with profound immunosuppression (e.g., CD4 counts less than 50 cells/µL) should receive ART
within the first two weeks of initiating TB treatment.
• TB meningitis patients with a new HIV diagnosis should have ART initiation delayed until after the first 8 weeks of ATT are
completed, regardless of CD4 count.

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D RUG R ESISTANT TB
Drug Resistant TB Patient Detection
The diagnosis and treatment of persons with drug resistant TB (DR-TB) starts with identification of a presumptive DR-TB patient.

Sputum samples from all presumptive TB patients should be sent for Xpert MTB/RIF rapid diagnostic testing, and a chest
x-ray should be obtained for patients when the diagnosis of TB is uncertain.

Every effort should be undertaken to confirm the diagnosis of RR-TB/MDR-TB with Xpert MTB/RIF, especially for patients in the
following risk categories:

• A close contact of a person diagnosed with DR-TB, especially if the person is not on treatment, is failing treatment, or has
recently died from DR-TB disease;
• Someone who has a history of TB treatment failure (either DS-TB or DR-TB), lost to follow up from DS-TB or DR-TB
treatment, or could be considered to have early relapse from a previously treated case of DS-TB or DR-TB (successfully
treated less than two years previously);
• HIV co-infected patients with severe immunosuppression: bacteriologic confirmation may be difficult so a history of contacts
and risk factors is important;
• Persons recently from facilities with high rates of DR-TB: the risk of nosocomial infection is high for healthcare workers,
miners, prisoners, and patients admitted for prolonged periods, especially in the absence of appropriate infection control
measures;
• DS-TB patients who remain smear positive ≥ 2 months on first line drug treatment, as this may indicate the presence of drug
resistance.
Diagnosis of Drug Resistant Tuberculosis

a) Clinical Presentation
• The clinical features of DR-TB are not different from those of drug susceptible TB (both pulmonary and extra-pulmonary
TB)

• DR-TB is by definition a bacteriological diagnosis. However, in patients where bacteriological confirmation is difficult, such
as children, HIV positive patients, or those with extra-pulmonary TB, and who are also close contacts of known DR-TB
patients, a clinical diagnosis of DR-TB can be made. Such cases should be discussed with the Clinical Expert Committee
(CEC)

b) Bacteriologic Confirmation
Xpert MTB/RIF has been recommended as the primary diagnostic test in all adults and children with signs and symptoms of
TB where available

• The diagnosis of DR-TB is done by Xpert MTB/RIF, line probe assay (first and Second-Line LPA), culture and phenotypic
drug susceptibility testing (pDST)

• In facilities where Xpert MTB/RIF is not yet available, samples should be referred to the nearest facility where the test is
available, especially for individuals with risk factors of DR-TB

• Only as a last resort should patients be started on empiric DS-TB treatment based on clinical history and positive smear
microscopy results alone (e.g. severely ill patients in whom treatment initiation should not be delayed pending Xpert
MTB/RIF, LPA, or culture/DST results

• Patients who require TB re-treatment based on history should NOT get the category II regimen (the standard DS-TB
regimen plus streptomycin). Instead, patients should get drug susceptibility testing with rapid molecular testing (Xpert
MTB/RIF, FL and SL LPA) to inform the choice of treatment. WHO no longer recommends the use of the category II
regimen

• For all patients with Rifampicin resistance detected on Xpert MTB/RIF, samples should be sent for SL LPA, culture and
phenotypic DST; for those eligible, the shorter DR-TB treatment regimen should be started while awaiting results from LPA
and/or culture/DST
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 • The turnaround time (specimen collection until receipt of results) for LPA and culture/DST results varies on when the test
becomes positive and the type of media used (e.g. liquid or solid media for culture):

o Line probe assay results should take between 3-14 days (turnaround time of LPA within the processing lab should be
48 hours);
o Liquid culture (MGIT): positive results at 4-14 days, negative result by 42 days;
o Solid culture (LJ): positive results at 28-56 days, negative result by 60 days;
o Phenotypic DST results (from the date culture was positive): MGIT 14 days, LJ 30 days;

• Phenotypic DST (pDST) is reliable and reproducible for Rifampicin, Isoniazid, Kanamycin, Amikacin, Ofloxacin,
Levofloxacin

o Moxifloxacin: there is a need for critical concentrations to be re-evaluated;

o Ethambutol, Streptomycin, Capreomycin, Ethionamide/Protionamide, Cycloserine, Pyrazinamide, para – Amino
Salicylic Acid: pDST is not reliable;
o New and repurposed drugs Bedaquiline, Delaminid, Clofazimine, Linezolid: pDST needs validation and is not
widely available outside of research settings
Causes of DR-TB
• Transmission from a patient with drug resistant TB

• Poor adherence to treatment by patients

• Use of anti-TB drugs of unproven quality (sale of such medications over the counter and on the black-market).

• Incorrect management of individual cases by clinicians

• Sub-optimal dosage

• Poor drug absorption

• Prolonged shortages of anti-TB drugs

Groups at Risk of DR-TB

• Contacts of DR- TB patients

• Patients previously treated for TB (Treatment failures, relapses, treatment after loss to follow up)

• Patients who are smear positive after 2 months of first line TB treatment

• TB patients who are close contacts of DR-TB cases.

• Healthcare workers

• Prisoners from facilities with high rates of DR-TB

Management of Presumptive DR-TB Patients
If a patient is presumed to have DR-TB, the following should be done:
• Collect sputum specimens for Xpert MTB RIF, LPA, culture and phenotypic DST
• Do not admit patient to a general ward (especially in high HIV settings as HIV positive individuals can easily get infected).

If hospital admission is necessary, the patient should be admitted to a special ward, which has good ventilation. At home advise
patient to sleep in a well-ventilated room that is separate from others (if possible). If DR-TB is confirmed by the laboratory the
patient should be referred for treatment at a designated treatment facility under strict supervision.

Detection of DR-TB patients

Case detection for DR-TB is similar to that of TB in general. The basis for identification of DR-TB
patient is bacteriological examination, which includes Xpert MTB/RIF, LPA, Culture and Phenotypic
Drug Susceptibility Testing (DST) as well as previous history of treatment.

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NEW DRUG RESISTANT TUBRECULOSIS (DR-TB) TREATMENT REGIMEN
The National TB and Leprosy Program (NTLP) has updated the 2018 MDR-RR/TB guidelines based on the most recent available
evidence from observational studies, individual patient data (IPD) metanalysis and clinical trials. Significant change is that
injectable agents are no longer among the priority medicines when designing longer mdr-tb regimens, with kanamycin
and capreomycin not recommended any more. Fully oral longer regimen lasting 18-20 months should thus become the
preferred option for most MDR-RR/TB patients.

The revised treatment regimen will be as follows;

Standardized Longer Treatment Regimen (Fully All Oral Options)

1. 6 Bedaquiline, Levofloxacin, linezolid, Clofazimine / 12 Levofloxacin, Linezolid, Clofazimine

(6Bdq-Levo-Lzd-Cfz/12Levo-Lzd-Cfz)*

2. 6 Bedaquiline, Levofloxacin/Moxifloxacin, Clofazimine. Cycloserine / 12

Levofloxacin/Moxifloxacin, Clofazimine, Cycloserine

3. 6 Bedaquiline, Linezolid, Clofazimine, Cycloserine / 12 Linezolid, Clofazimine, Cycloserine

*Preferred option for most patients

Shorter Treatment Regimen

4-6 Amikacin, Moxifloxacin, Clofazimine, Ethionamide, Pyrazinamide, Ethambutol, High Dose Isoniazid/ 5 Moxifloxacin,
Clofazimine, Pyrazinamide, Ethambutol (4–6 Am-Mfx-Cfz-Eto-Z-E- HHD / 5 Mfx-Cfz-E-Z)
The standardized, shorter MDR-TB regimen may be offered to eligible patients who agree to a briefer treatment (9-12 months) that
may be less effective than standardized fully oral longer regimen and that requires a daily injectable agent for at least four months.
Monitoring MDR- TB regimens with monthly culture rather than sputum microscopy alone offers the best option to detect a failing
regimen in time for corrective action
Note: Decisions to start newly diagnosed patients on the standardized shorter MDR-TB regimen should be made after
discussing with patient and based on clinical judgement.

Modified Shorter Treatment Regimen Under Operation Research Conditions

4-6 Bedaquiline, Moxifloxacin, Clofazimine, Ethionamide, Pyrazinamide, Ethambutol, High Dose Isoniazid/ 5
Moxifloxacin, Clofazimine, Pyrazinamide, Ethambutol (4–6 Bdq-Mfx-Cfz-Eto-Z-E- HHD / 5 Mfx-Cfz-E-Z)

Individualized Treatment Regimen

For patients who are not eligible for the Standardized Longer treatment regimen (all oral) or Shorter regimen, an individualized
treatment regimen should be designed. The patients include pre-XDR-TB and XDR-TB patients.
Note: Individualized regimen should usually be designed to include at least five medicines considered to be effective.
IMPORTANT MASSAGES

• Every DR-TB patient should be followed very closely by each individual treatment centre and all records should be well
documented in both paper and electronic registers

• Ensure a complete baseline assessment is done at the time of starting the patient on second line drugs

• Follow up monthly smears, cultures and biochemistry tests is a must. When Amikacin is used audiometry tests at baseline
and during treatment should be done

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 • Active monitoring and reporting of any adverse effects are the corner stone of good patient care practice

• The Provincial Clinical Expert Committee (CEC) should evaluate every DR-TB patient at treatment initiation and on
monthly basis. Any change of the drug regimen should also be discussed

• Complicated cases should be brought to the attention of the National MDR-RR/TB Clinical Expert Committee

• Interim and final outcomes should be reported the National TB and Leprosy Program

• All DR-TB patients must be followed for at least 2 years post treatment
F I G U R E 24: RR/DR TB P A T I E N T T R I A G E F L O W C H A R T

#
RR-TB patient

SEND SAMPLE FOR SL LPA AND CULTURE/DST

EVALUATE PATIENT USING THE FOLLOWING ELIGIBILITY

CRITERIA FOR SHORTER DR-TB TREATMENT REGIMEN

1. No evidence of FQ and/or SLI

2. No contact with patient that has resistance to FQ/SLI
3. No exposure to SLD for ≥ 1 month
4. No known intolerance to drugs in the shorter
regimen
5. Not pregnant
6. No EPTB*
7. No other risk of unfavourable outcome**

Eligible Ineligible
Initial treatment
regimen Shorter DR-TB Individualized DR-TB
Treatment Regimen Treatment Regimen

Regimen adjustment based NO Resistance/intoler Resistance/intolera NO

on: resistance/intoler ance to SLI and/or nce to SLI and/or resistance/intoleran
• SL DST results ance to SLI and/or FQ FQ ce to SLI and/or FQ
• Treatment tolerance FQ

Continue shorter Change to Continue Continue treatment

DR-TB Treatment individualized DR- individualized whilst consulting experts
TB Treatment DR-TB on potential regimen
regimen Treatment adjustment based on DST
regimen results and clinical status
# Includes patients with high risk of Rifampicin resistance as contacts of RR-/MDR-TB patients
* Non-severe forms of EPTB that can be eligible for the shorter treatment regimen include TB pleural effusion (adults and children)
and TB lymph node (children)
** Risk of unfavorable outcome includes extensive or advanced TB disease (multiple

Abbreviations: RR-TB = Rifampicin resistant TB; SL DST = Second-Line drug susceptibility test; DR-TB = Drug-resistant TB; FQ =
Flouroquinolone; SLI = Second-Line drugs; EPTB = Extra-pulmonary TB

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Dosage and administration
T A B L E 32: W E I G H T - B A S E D DR-TB D R U G S IN A D U L T S ≥30 KG

Drugs Daily dose 30–35 kg 36–45kg 46–55 kg 56–70kg >70 kg

10 mg/kg Maximum 600

Isoniazid- High dose (Hh) 300 mg 400 mg 500 mg 600 mg 600 mg
mg/day

Pyrazinamide (Z) 20–30mg/kg once daily 800 mg 1000 mg 1200 mg 1600 mg 2000 mg

Ethambutol (E) 15–25 mg/kg once daily 600 mg 800 mg 1000 mg 1200 mg 1200 mg

Kanamycin/Capreomycin/
15–20 mg/kg once daily 500 mg 625 mg 750 mg 825 mg 1000 mg
Amikacin (Km/Cm/Am)

Levofloxacin (Lfx) 750–1000mg once daily 750 mg 750 mg 1000 mg 1000 mg 1000 mg

<50kg=600mg
Moxifloxacin (Mfx) 400 mg once daily 400 mg 600 mg 800 mg 800 mg
>50kg=800mg

Prothionamide (Pto)/ 500–750 mg/day in 2

500 mg 500 mg 750 mg 750 mg 1000 mg
Ethionamide (Eto) divided doses

Cycloserine (Cs)/ 500–750 mg/day in 2

500 mg 500 mg 500 mg 750 mg 750 mg
Terizidone (Trd) divided doses

p-aminosalicylic acid 8 g/day in 2 divided

8g 8g 8g 8g 8–12 g
(PAS) doses

Bedaquiline (Bdq) 400 mg once daily for 2 weeks then 200 mg 3 times per week

Delamanid* (Dlm) 100 mg twice daily (total daily dose = 200 mg)

Clofazimine (Cfz) 100 mg twice daily for 2 first months, then reduce to 100 mg daily

Linezolid (Lzd) 600 mg once daily 600 mg 600 mg 600 mg 600 mg 600 mg

Amoxicillin/clavulanate 80 mg/kg/day in 2 divided

2600 mg 2600 mg 2600 mg 2600 mg 2600 mg
(Amx/clv) 7/1 doses

Amoxicillin/clavulanate 80 mg/kg/day in 2 divided

3000 mg 3000 mg 3000 mg 3000 mg 3000 mg
(Amx-clv) 8/1 doses

Imipenem/Cilastatin
1000mg Imipenem/1000 mg Cilastatin twice daily
(Imp/cln)

Meropenem (Mpm) 1000mg three times daily (alternative dosing is 2000 mg twice daily)

* Use of Delamanid in the shorter MDR-TB regimen under programmatic conditions is not recommended given the lack of data.
However, it can be used when other options are not available and should be under Clinical Experts' guidance

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Treatment Monitoring for MDR-TB/RR-TB Patients on Therapy

Adverse effects may occur with MDR-TB drugs and are dose dependent. However adverse effects can occur at normal dose.
Patients should be monitored for adverse effects at each contact with a healthcare provider

• Patients should be monitored closely for signs of • Weight should be monitored monthly and drug
treatment failure and adverse drug reactions dosages should be adjusted accordingly.
(compare baseline and follow up examinations).

• Treatment can be monitored through clinical • For patient under individualized regimen,
history; physical examination; psychosocial additional monitoring is required: ECG (Dlm, Bdq),
assessment; chest radiography; audiometry, Serum Albumin (Dlm), and for Linezolid: vision test
bacteriological test (smear and culture); laboratory chards, Serum Amylase/Lipase and monthly
monitoring (hematology-FBC, Creatinine, hematology-FBC.
Potassium, LFT, TSH); Pregnancy test, hepatitis
B, C and HIV test (if positive CD4 and VL
every 6 months) should be included when doing
the baseline investigations.

For details on adverse effects monitoring and management, refer to the DR-TB manual

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 T A B L E 33: DR-TB TREATMENT MONITORING SCHEDULE FOR CONVENTIONAL DR-TB REGIMEN

Parameters Month of Treatment

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Clinical evaluation X X X X X X X X X X X X X X X X X X X X X

Sputum-smear X X X X X X X X X X X X X X X X X X X X X

Sputum-culture X X X X X X X X X X X X X X X X X X X X X

DST X P P P P P P P P P P P P P P P P P

FBC/DC X X X X X

LFTs X X X X X X X X

Na2+ , K2+, u , Creatinine X X X X X X X X I I I I I I I I I I I

TSH/free T-4 X X X X X X X X

Pregnancy test X

HIV test X X X X X X X

Audiometry X X X X X X X X X X X X X X X X X X X X

CXR X O O O

KEY: X=Required, O=Optional, P=If culture is positive, I=If indicated

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H EPATITIS B AND HIV
Screening and Management of Hepatitis B Virus (HBV) and HIV Co-Infection
• Patients with HIV-HBV co-infection experience twice the risk of mortality during ART compared to HIV-infected individuals
who do not have HBV
• Both 3TC and TDF are active against HBV; however, using 3TC as the only HBV-active antiretroviral drug will lead to HBV
drug resistance and is not recommended. ART regimens that contain TDF as the only HBV-active antiretroviral are okay
because HBV resistance with TDF alone is very very rare
• Hepatitis B surface antigen (HBsAg) should be done at baseline and in patients with unknown HBV status
• For children who have been fully vaccinated (i.e., 3 doses), do not screen for HBV unless there is strong clinical suspicion
• Start TDF-containing ART regardless of CD4 count in HIV/HBV co-infected patients
• Patients failing 1st-line TDF + XTC treatment should continue the TDF in their 2nd-line therapy (i.e. TDF+AZT+3TC+LPV-r
or ATV-r) to control their HBV infection
• For HBsAg positive patients with renal insufficiency (CrCl <50mL/min), consult or refer to next level
• For HBV-HIV co-infection in child <10 years old, consult or refer to the next level

H EPATITIS B M ONO -I NFECTION

Screening and Management of Hepatitis B Virus (HBV)

• Hepatitis B surface antigen (HBsAg) should be used for screening and diagnosis of active HBV infection; a negative HIV
test is required to classify a person as having HBV mono-infection.
• The ZAMPHIA study reported that 5.6% of adults were hepatitis B surface antigen positive; of these most were HIV-negative.
• Other hepatitis B tests (like surface antibody or core antibody, core antibody, HBVe antigen and HBV DNA viral load) can
be used to know if the person has active infection
• Many cases of active HBV infection will not require immediate antiviral therapy but instead can be observed and followed
up every 6-12 months
• APRI (AST-to-platelet ratio index) is the preferred non-invasive test (NIT) to assess for the presence of cirrhosis and can be
calculated as follows:

[AST Level / AST (Upper Limit of Normal)]

APRI = _____________________________________________ × 100

Platelet Count (109/L)

APRI Score Interpretation

AST aminotransferase to Platelet Ratio Index

• APRI score >2.0 in adults is highly suggestive of cirrhosis

• APRI score <1.0 can rule out the presence of cirrhosis
• APRI score 1.0-2.0 is a gray area

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Eligibility Criteria for Antiviral Treatment

• The presence of cirrhosis is a treatment indication in all adults, adolescents, and children with chronic HBV infection
regardless of ALT levels, HBeAg status, or HBV DNA levels
• Diagnosis of cirrhosis is based on APRI score >2.0 in adults
• Clinical signs of decompensated cirrhosis may include portal hypertension (ascites, variceal haemorrhage, and hepatic
encephalopathy), coagulopathy, or liver insufficiency (jaundice). Other clinical features of advanced liver disease/cirrhosis
may include hepatomegaly, splenomegaly, pruritis, fatigue, arthralgia, palmar erythema, and edema
• Treatment is recommended for adults who do not have clinical evidence of cirrhosis (or based on APRI score >2 in adults)
but do have one of the following:
o Persistently elevated ALT levels and evidence of high-level HBV replication (HBV DNA >20 000 IU/mL), regardless
of HBeAg status
o When HBV DNA testing (and/or HBeAg testing) is not available, treat when ALT is persistently elevated. Persistent
means at least two elevated ALT levels over 6-12 months and newer HBV guidelines now define ‘ALT elevation’
as ALT >19 U/L for women and ALT>30 U/L for men
o In HBV/HIV co-infected individuals, TDF based ART should be initiated regardless of CD4 count
• Remember in Zambia other common causes of ALT elevation are medications (such as ATT), liver infections (such as TB),
and heavy alcohol consumption
• In treatment-eligible patients, measurement of creatinine is recommended

Non-Eligible Patients

Antiviral therapy is not recommended or deferred in the following situations:

• No clinical evidence of cirrhosis

• APRI score ≤2.0 in adults
• Persistently normal ALT levels (i.e., ALT ≤20 in women and ≤30 in men)
• Low levels of HBV DNA replication (HBV DNA <2000 IU/mL), regardless of HBeAg status

Continue monitoring in all persons with chronic HBV infection especially those who do not meet the above eligibility and non-eligibility
criteria to determine if antiviral therapy may be indicated in the future to prevent progressive liver disease. Monitoring could be done
every 3-6 months in those with ALT elevation and every 6-12 months in those with normal ALT.

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First-Line Regimen
• In all adults, adolescents and children aged 10 years or older the preferred drug is TDF + 3TC
• In children aged 2 to <10 years, Entecavir is the preferred drug over Tenofovir
• The dosing should be as follows:
o Tenofovir 300mg once daily
o Tenofovir 300mg plus Lamivudine 300mg
o Entecavir 0.5mg once daily (adult with compensated liver disease and lamivudine naive)
o Entecavir 1mg once daily (adult with decompensated liver disease)
• Patients with CrCl <50 mL/min should be referred to a higher level for further management
• Counselling patients that HBV treatment is potentially lifelong is important to set their expectations

Monitoring of Therapy in HBV

• There are several goals of HBV antiviral therapy, as follows:
o Suppression of HBV viral load (i.e., HBV DNA below assay detection)
o Normalization of the ALT
o Conversion from HBeAg-positive to negative
o Conversion from HBsAg-positive to HBsAg-negative
• Repeat ALT every 6 months is recommended during treatment
• Every 1-2 years HBsAg can be repeated; however, conversion to HBsAg-negative occurs at a rate of <5% per year during
chronic infection
• Repeat creatinine every 12 months is also recommended as TDF carries a small risk of renal toxicity
• Repeat an HIV antibody test every 12 months; if patient becomes HIV-positive during HBV treatment (i.e., HIV-HBV co-
infection), ART should be initiated

When to Discontinue Therapy

• Discontinuation of HBV-active therapy can be associated with a fatal flare-up of hepatitis; therefore, counsel patients that
after stopping they should return if they develop fever and jaundice or other signs of liver disease
• When there is evidence of conversion from HBeAg-positive to HBeAg-negative and after completion of at least one additional
year of treatment AND the ALT is persistently normal
• When there is conversion to HBsAg loss and completion of at least one additional year of treatment and the ALT is
persistently normal
• If HBV DNA testing is available, persistently undetectable HBV DNA in addition to the above criteria should also guide when
to discontinue
• IMPORTANT NOTE: Relapse may occur after stopping therapy, especially in patients who were HBeAg-negative at the start
of antiviral therapy. Therefore, after discontinuation, ongoing monitoring of ALT (every 6-12 months) is recommended.
Restart therapy if there are signs of reactivation such as HBsAg or HBeAg become positive, ALT levels increase significantly,
or HBV DNA becomes detectable again

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General Measures to Reduce HBV Transmission
• HBsAg-positive persons should adopt correct and consistent condom use during sexual intercourse; not share razors,
toothbrushes, or other personal care items; not donate blood, organs, or sperm; and follow standard universal precautions
with open cuts or bleeding
• HBV vaccination of household and sexual contacts to HBsAg-positive individuals. Household members and sexual partners
of persons with Chronic Hepatitis B should be vaccinated if they are negative for HBsAg
• Alcohol reduction to reduce disease progression
• Infants should receive all vaccines recommended through the Extended Program on Immunizations
• Infants born to HBsAg-positive mothers should have an HBV vaccine as soon as possible after birth if possible, which
provides protection against mother to baby transmission

Measures to Reduce HBV Transmission in Hospital Settings

• Healthcare workers should be tested for HBsAg and vaccinated if they are negative for HBsAg
• Hand hygiene: including surgical hand preparation, hand washing, and use of gloves
• Safe handling and disposal of sharps and waste
• Safe cleaning of equipment
• Testing of donated blood
• Improved access to safe blood
• Training of health personnel

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C RYPTOCOCCAL D ISEASE AND HIV I NFECTION

Diagnosis of Cryptococcal Disease

• Prompt lumbar puncture with measurement of Cerebrospinal fluid (CSF) opening pressure and rapid CSF Cryptococcal
antigen (CrAg) assay or rapid serum CrAg (either LA or LFA) is the preferred diagnostic approach

Prevention of Cryptococcal Disease

• The routine use of antifungal primary prophylaxis for Cryptococcal disease in HIV-infected adults, adolescents, and children
with a CD4 count less than 100 cells/µL and who are CrAg negative or where CrAg status is unknown is not recommended
before ART initiation, unless a prolonged delay in ART initiation is likely

Treatment Options
• Induction phase of treatment in HIV-infected adults, adolescents, and children with cryptococcal disease (meningeal and
disseminated non-meningeal)
• The following two-week antifungal regimens are recommended in order of preference.
o Amphotericin B + Fluconazole
o Amphotericin B + Flucytosine

• For the consolidation phase treatment of HIV-infected adults, adolescents, and children with cryptococcal meningitis or
disseminated non-meningeal disease, the following eight-week antifungal regimen is recommended:
o Fluconazole 400–800mg/day after a two-week induction with Amphotericin B regimen (6–12mg/kg/day up to
400–800mg/day, if below 19 years)
o Fluconazole 800mg/day after induction treatment with short-course Amphotericin B or Fluconazole-based induction
regimen (Fluconazole 12mg/kg/day up to 800mg/day, if below 19 years)

• For maintenance treatment of cryptococcal disease in HIV-infected adults, adolescents, and children, oral Fluconazole
200mg daily (6mg/kg/day up to 200mg/day, if below 19 years) is recommended

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M ENTAL H EALTH AND HIV I NFECTION
All HIV patients should be assessed and managed for neuropsychiatric conditions (e.g., depression, anxiety, mania, alcohol and
substance use, HIV-associated neurocognitive disorder, and delirium disorders) may have a substantial impact on HIV disease
progression and ART adherence. For individuals with mental illness, refer to a mental health provider. If an individual with mental
illness appears to worsen after EFV-400mg initiation, consider switching EFV-400mg to ATV-r or LPV-r (avoid ATV-r if HIV-2).
Non–Communicable Diseases and HIV

Cardiovascular Disease (CVD) assessment and Management of Non-Communicable Diseases (NCDs)

HIV-infected persons are at increased risk of cardiovascular disease and other non-communicable diseases, including cancers. This
is in part because of the chronic immune activation that persists even in HIV infection, even if on treatment. Assessment and
management of cardiovascular risk should be provided for all individuals living with HIV according to standard protocols
recommended for the general population using risk factors:
• Older than 40 years, obesity, diabetes mellitus, known hypertension, waist circumference of >90cm (women) and 110cm
(men), family history of premature CVDs
Up to two thirds of premature deaths from the major NCDs are linked to four shared modifiable risk factors:
• Tobacco use, harmful use of alcohol, unhealthy diet, and physical inactivity.
These risk factors result in a series of metabolic and physiological changes that eventually lead to NCDs. Broader social, economic,
and environmental determinants of health and inequities associated with globalization and urbanization, alongside population ageing,
are the underlying drivers of the behavioural risk factors, and thus the NCD epidemic.

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F I G U R E 25: C A U S A L L I N K S B E T W E E N U N D E R L Y I N G D R I V E R S FOR NCD S , B E H A V I O R A L R I S K F A C T O R S ,
M E T A B O L I C /P H Y S I O L O G I C R I S K F A C T O R S A N D NCD S

Raised Blood Pressure,

Overweight/Obesity,
Raised Blood Glucose,
Raised Lipids

Social Determinants of
Health/Globalization, Urbanization,
Population Ageing

Tobacco Use, Unhealthy Diet, Physical Inactivity,

Harmful Use of Alcohol

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T A B L E 34: L I F E S T Y L E M O D I F I C A T I O N S TO PREVENT AND M A N A G E CVD S A M O N G HIV-I N F E C T E D
INDIVIDUALS

Smoking Cessation

• Smoking cessation has multiple short-term and long-term benefits, including:

ü Skin does not age/wrinkle as quickly
ü Improved fitness and quicker recovery from common infections
ü Reduced risk of respiratory infections and chronic lung disease
ü Reduced risk of high blood pressure, diabetes, kidney disease, heart disease, and stroke
ü Improved infant outcomes (for pregnant women who smoke)
ü Reduced risk of cancers: lung, bladder, breast, mouth, throat, esophagus
ü Evidence of better response to ART (better viral suppression)

Dietary Changes and Weight Loss

ü Weight loss to maintain a healthy BMI (nutritionists to be engaged in patient care)

ü Reduce/abstain from alcohol
ü Cut down sugar intake
ü Cut down red meat intake
ü Cut down consumption of fatty foods, fat for flavouring, and fried foods
ü Increase intake of whole grains, vegetables, fruit, and beans (eating at least five servings of fruit and vegetables a day)
ü Increase intake of fish
ü Cut down salt intake to less than one teaspoon a day
Physical Activity
• Active lifestyle with moderate-intensity physical activity

• 30 minutes of aerobic activity such as brisk walking, at least 5 days per week
T A B L E 35: D Y S L I P I D A E M I A S C R E E N I N G , D I A G N O S I S , AND INITIAL MANAGEMENT FOR HIV-I N F E C T E D
INDIVIDUALS

Screening

• Fasting lipid profile should be evaluated at baseline for all PLHIV, then annually if baseline screening is normal

Diagnosis

• Dyslipidaemia is defined as high fasting total cholesterol (>5.2mmol/L), LDL (>3.4mmol/L) or triglycerides (>2.2mmol/L)

Management

• Lifestyle modifications for 3-6 months

• If the patient is on an ARV known to cause or exacerbate dyslipidaemia (primarily LPV-r) then consider a single-drug
substitution to a more lipid-friendly drug (such as from LPV-r to ATV-r) as the treatment of choice before adding a lipid-
lowering drug.
• If does not meet treatment target with lifestyle modifications, then add drugs:
ü Atorvastatin: starting dose of 10mg OD (maximum dose 20mg if patient is on a PI/r and a maximum dose of 80mg once
daily if not on a PI/r)
ü Allow at least 3 months before repeating fasting lipids and titrating dose
• Once targets achieved can monitor lipids every 6-12 months

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T A B L E 36: H Y P E R T E N S I O N S C R E E N I N G , D I A G N O S I S , AND INITIAL MANAGEMENT FOR HIV-I N F E C T E D
INDIVIDUALS

Screening
• BP should be measured and recorded at every visit

Diagnosis
• Hypertension requiring intervention is defined as BP ≥140/90mmHg on at least two different occasions
ü It can also be diagnosed at the same visit if the BP is 180/110 or any BP associated with target organ damage

Management
If baseline BP is 140-159/90-99:

• Lifestyle modifications for at least 6 months, along with monthly BP monitoring

• If does not meet treatment target with lifestyle modifications, then add drugs:
ü Introduce 1 drug at a time, and allow 2-3 weeks to achieve maximal effect before titrating up dosage; titrate to
maximum dosage before adding an additional drug
ü In PLHIV without kidney disease or diabetes, First-Line antihypertensive therapy is a thiazide diuretic such as
Hydrochlorothiazide starting at 12.5mg OD (maximum dose 25mg OD) OR a calcium channel antagonist such as
Amlodipine starting at 2.5mg OD (maximum 10mg OD)
ü In PLHIV with kidney disease or diabetes the first antihypertensive should be an ACE-I or ARB such as Enalapril
2.5-10mg OD (maximum dose is 20mg BD); Losartan 50mg OD (maximum dose is 100mg OD)
ü If inadequate response once dose has been titrated, an additional agent may be required (e.g., Hydrochlorothiazide
starting at 12.5mg OD [maximum dose 25mg OD])
ü If inadequate response to two agents, consider consultation with or referral to a clinician experienced in the
management of refractory hypertension. Note: Calcium-channel blockers have known drug interactions with PIs and
NNRTIs and should be used with caution
• If baseline BP ≥160/100mmHg: initiate lifestyle modifications and introduce anti-hypertensive medications concurrently
• Target BP measurements
ü Diabetic patients: <140/90
ü None Diabetic & Chronic Kidney Disease (CKD) patients: 140/90
ü None Diabetics & None CKD patients: <140/90 (<60 years); 150/90 (>60 years old)

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T A B L E 37: T Y P E 2 D I A B E T E S M E L L I T U S S C R E E N I N G , D I A G N O S I S , AND INITIAL MANAGEMENT FOR HIV-
INFECTED INDIVIDUALS

Screening

• Blood glucose (fasting or random) should be evaluated at baseline for all PLHIV, then annually if baseline screening is
normal; urine dipstick for protein and glucose can be used if blood glucose testing is not available

Diagnosis

• Diabetes Mellitus is defined as fasting blood sugar ≥7.0mmol/L, or random blood sugar ≥11.1mmol/L, or HbA1C >6.5%
• Abnormal results should be repeated to confirm the diagnosis

Management (treatment target is HbA1C ≤7.0% or FBS 4-7mmol/L)

• Monitor HbA1c (or FBS if HbA1c not available) every 3 months for patients with confirmed diagnosis of diabetes mellitus
• Lifestyle modifications (weight loss, nutritional support to manage portion sizes and calculate glycaemic index of various
foods to help with control of blood sugar) for 3-6 months
• If does not meet treatment target with lifestyle modifications, then add drugs:
ü Metformin
ü Obtain baseline Creatinine; do NOT use Metformin if creatinine clearance <45mL/min
ü Start with low dose (500mg OD or BD) and titrate up every 1-2 weeks until reaches 1g BD (or maximum tolerated dose
if less than 1g BD)
ü If does not meet treatment targets with Metformin for 3-6 months at maximum tolerated dose, then consider adding oral
drugs from another class (such as glyburide) and/or specialist consultation. Some patients may require Insulin
• At every visit: A thorough history (to elicit features of hypoglycaemia, other cardiovascular disease risk factors, neuropathy,
diabetic foot ulcers) and a physical exam (for BP, neuropathy, foot ulcers)
• Additional routine screening for patients with diabetes:
ü Annual ophthalmology examination for diabetic retinopathy
ü Annual urinalysis: start on an ACE-I/ARB if proteinuria develops (even if BP normal)

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T A B L E 38: C H R O N I C K I D N E Y D I S E A S E S C R E E N I N G , D I A G N O S I S , AND INITIAL MANAGEMENT FOR HIV-
INFECTED INDIVIDUALS

Screening

• Urinalysis (for protein) and serum creatinine should be evaluated at baseline for all PLHIV

Diagnosis

• Impaired renal function is defined as creatinine clearance < 50mL/min, or dipstick proteinuria ≥ 1
• Abnormal results should be repeated to confirm diagnosis

Management

• Management depends on the cause of the renal impairment; additional investigations and/or specialist consultation may be
required
• Treat dehydration promptly and aggressively
• If on TDF-containing regimen, substitute with another ARV, with the exception of patients with HBV/HIV co-infection who
need TDF to be maintained on adjusted doses or switch to Entecavir (see section on Hepatitis B/HIV co-infected)
• Avoid nephrotoxic drugs
• Evaluate for and treat hypertension
• All NRTIs except ABC require dose adjustments for renal impairment, depending on the severity. NNRTIs, PIs, and
Integrase Strand Transfer Inhibitors (INSTIs) do not require dose adjustments for impaired renal function

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CERVICAL CANCER AND HIV
Cervical cancer is preventable and is curable if diagnosed and treated early. All women regardless of age should be assessed for
cervical cancer; women living with HIV have a higher risk of pre-cancer and invasive cancer (women with HIV are 4-5 times more
likely to develop cervical cancer). Cervical cancer screening leads to early detection with HPV test or visual inspection with acetic
acid (VIA).

F I G U R E 26: C E R V I C A L C A N C E R S C R E E N I N G A L G O R I T H M WITH VIA

VIA

Positive Suspicious for

Negative
Cancer

Eligible for Not eligible for Refer for diagnosis

Rescreen: 2 years
Cryotherapy Cryotherapy & treatment

Cryotherapy LEEP

Review 1-year post Review 1-year post

treatment treatment

VIA = Visual Inspection with Acetic Acid; LEEP = Loop Electrosurgical Excision Procedure

F I G U R E 27: C E R V I C A L C A N C E R S C R E E N I N G A L G O R I T H M WITH HPV T E S T I N G

HPV TEST
VIA to determine
• Perform VIA eligibility for
• Rescreen within 2 years* Cryotherapy

Eligible Not eligible Suspicious for

Do Cryotherapy Do LEEP Cancer

Follow-up, 1-year Follow-up, 1-year Refer

HPV = Human Papiloma Virus; VIA = Visual Inspection with Acetic Acid; LEEP = Loop Electrosurgical Excision Procedure

* In HIV Negative women, rescrenn minimum 5 years

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Terminal Illness/Cancer and HIV

• Palliative care aims to relieve suffering in all stages of disease and is not limited to end-of-life care. The goals of palliative
care include:
o To improve the quality of life
o To increase comfort
o To promote open communication for effective decision making
o To promote dignity
o To provide a support system to the person who is ill and those close to them

In HIV-infected individuals, palliative care focuses on symptom management and end-of-life care. Throughout all stages of HIV
disease, including when on ART, individuals may experience various forms of pain and other discomfort. HCWs should identify and
treat the underlying cause when possible, while controlling the pain. Effective management of side effects and possible overlapping
ART-associated toxicities is important to support adherence

The care of the terminally ill child is a particular challenge in Zambia because there are few replicable models of planned terminal
care, both institutional and community-based. At the end of life, there are typically more symptoms that must be addressed, and the
child may need to take multiple drugs to control and treat a variety of symptoms and conditions.

Terminal care preparation for children and their families is a long-term process and requires continuity of care through providers and
services. Families must be involved in decisions about the best place for care and the preferred place of death in the child with end-
stage HIV disease

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T A B L E 39: R E C O M M E N D E D T E S T S FOR HIV S C R E E N I N G AND MONITORING FOR CO-INFECTIONS AND
NCD S

Phase of HIV Management Recommended Desirable (*if feasible)

• HIV testing (serology for adults and • HBV or HCV serology
HIV Diagnosis
children 18 months or older: NAT or • Screening for STIs
children younger than 18 months • Hb or FBC
• Screen for TB • Pregnancy test (woman of
• CD4 cell count (assess CTX) reproductive age)
• HPV test or visual inspection with
acetic acid (VIA) in sexually active
adolescent or woman)
• Syphilis test (adolescent or adult)
• NCDs risk factors: cholesterol,
glucose, and triglycerides

ART Initiation • Hb
• Pregnancy test (woman of
reproductive age)
• BP measurement
• Serum creatinine (for starting TDF)
• Baseline CD4
• Viral load (at 6 months, 12 months after • Pregnancy test, especially for
Receiving ART
initiating ART and every 12 months women of childbearing age not
thereafter) receiving family planning or on
treatment with TDF+XTC+EFV-
400mg
• Serum creatinine for TDF

Suspected Treatment Failure • Serum creatinine for TDF • HBV (HBsAg) serology (for HIV/HBV
• Pregnancy test, especially for co-infected already using TDF and
women of childbearing age not develop ART failure, TDF should be
receiving family planning or on maintained regardless of selected
treatment with TDF+XTC+EFV- 400mg Second-Line regimen)
• And review CTX adherence
• Initiate ART if eligible
• Adherence counselling and positive
health dignity and prevention
(PHDP) messages

*Reference 2016 WHO Guidelines

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P ROPHYLAXIS
T UBERCULOSIS I SONIAZID P REVENTIVE T HERAPY (TB-IPT)
These guidelines focus on key interventions branded as the THREE I's (Intensive case finding, Isoniazid prophylaxis therapy,
Infection control for TB) for HIV-TB activities that reduce TB-related morbidity and mortality in HIV-infected individuals. Another key
intervention is the provision of ART.

Daily TB-IPT can prevent TB in people who are at a high risk for developing TB, including HIV-infected individuals.

• Screen all patients for TB at any opportunity that presents (see )

• Screen all pregnant and breastfeeding women, regardless of HIV status, for TB at every contact as it is part of Focused
ANC
• Screen all children for TB at every contact

• Give TB-IPT for 6 months to the following:

o HIV-infected children <12 months old with TB contact and after ruling out active TB
o Newly HIV-infected pregnant and breastfeeding women, children ≥12 months old, adolescents, and adults after
ruling out active TB
o After completing a full course of ATT, HIV-infected children should be given an additional IPT x 6 months
• Do not give IPT to a patient who has any signs suggestive of active TB. This patient needs full investigation for TB and
combination TB treatment if confirmed to avoid TB drug resistance.

• Standard TB screening questions include:

o Current cough: any duration, productive or non-productive
o Unexplained weight loss (adults)
o Failure to thrive and/or malnutrition (children)
o Fever or night sweats

• Contraindications and/or when to Stop IPT:

o Suspected or confirmed active TB (start ATT)
o Jaundice and/or icterus (yellow eyes) or active hepatitis
o Known or suspected hypersensitivity to INH or severe skin rash
o Confusion/convulsions
o Dizziness
o Peripheral neuropathy i.e. Severe numbness/burning pain and muscular weakness of legs and/or arms
o Concomitant medication: Phenytoin, Carbamazepine, Warfarin, Theophylline, Selective Serotonine Re-uptake
Inhibitor antidepressants (e.g. Fluoxetine, Paroxetine) oral Ketoconazole or Itraconazole

• How to give IPT

o Give IPT during pre-ART period and to HIV-infected children <12 months old with TB contact and after ruling out
active TB
o Review and assess for side effects at months 1, 3, and 6 after starting IPT
o IPT initiation: Give INH and Pyridoxine for 1 month
o Month 1: Give INH and Pyridoxine for 2 months
o Month 3: Give INH and Pyridoxine for 3 months
o Give concomitant Pyridoxine (vitamin B6) 1 tablet 25mg once daily to prevent side effects of Isoniazid in pregnant
and breastfeeding women, adolescents, and adults.

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T A B L E 40: D O S A G E F O R I S O N I A Z I D P R E V E N T A T I V E T H E R A P Y , C O - T R I M O X A Z O L E P R O P H Y L A X I S , AND
C O M B I N A T I O N INH/CTX/V I T B6 D R U G S

Drug Child tablet or Number of scoops or tablets by weight band Adult tablet
oral suspension
3 to < 6kg 6 to < 10kg 10 to < 14kg 14 to < 20kg 20 to < 25kg ≥ 25kg

Isoniazid 100mg 0.5 1 1.5 2 2.5 300mg

(INH) (1 tablet)

Co-trimoxazole Suspension 2.5 mL 5 mL 5 mL 10 mL 10 mL ─

(CTX) 200/40mg per mL

Tablet 1 2 2 4 4 ─

100/80mg
Tablet NA* 1# 1# 1 1 400/80mg
2 2
400/80mg (2 tablets)

Tablet NA NA NA 1# 1# 800/160mg
2 2
800/160mg (1 tablet)

Pyridoxine Tablet NA NA NA 1# 1# 25mg

2 2
(Vitamin B6 25mg (1 tablet)

INH/CTX/Vit B6 Tablet NA NA NA 1# 1# 300/960/25mg

2 2
300/960/25mg (1 tablet)

*NA = Not Applicable

C O - TRIMOXAZOLE P REVENTIVE T HERAPY (CPT)

CPT prevents Pneumocystis Jirovecii Pneumonia (PCP), toxoplasmosis, isosporiasis, malaria, and other HIV- and non-HIV related
diseases and prolongs survival. CPT can be safely taken with ART and/or ATT and in pregnancy (Table 15 and 16). HIV-infected
pregnant women on CPT should not be given Sulfadoxine-Pyrimethamine (SP; malaria prophylaxis in pregnancy)

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T A B L E 41: C R I T E R I A FOR INITIATING, DISCONTINUING AND MONITORING CO-TRIMOXAZOLE PREVENTIVE
THERAPY

Specific
populations Whom to Start When to Start When to Stop*

Start as early as possible. Do

Pregnant women not give SP. If SP taken, start Continue throughout pregnancy
Pregnant & CTX after 14 days
Breastfeeding
Women
CD4 count ≥350 cells/µL for two
Continue if CD4 count <350
Breastfeeding women consecutive values at least 6
cells/µL or WCS II, II or IV
months apart while on ART

HIV-exposed Confirmed HIV-uninfected after full

At 6 weeks old or first contact
(e.g. breastfed) child cessation of breastfeeding

HIV-infected child ≤24 Start regardless of WCS or

months old CD4%
At 5 years old and CD4 ≥25% and
Children (0 to <5 Stage I
HIV-infected child ≥24 WCS II, III and IV or CD4 level
years old) months to <5 years old <25%

Presumptive HIV Stop if confirmed HIV negative; if

Start (or continue) regardless of
diagnosis <24 months infected, stop at 5 years old and
WCS or CD4%
old CD4 level ≥25% and Stage I

At 5 years old and CD4 level ≥25%

and Stage I
Child with a history of Start regardless of CD4 count or
PCP CD4% If 5 to <10 years old, stop based
Children (5 to <10
on adult criteria
years old)

HIV-infected children ≥5 CD4 count ≥350 cells/µL for two

Adolescents CD4 count <350 cells/µL or
years old, adolescents, consecutive values at least 6
WCS II, III or IV
and adults months apart while on ART
Adults

Stop CTX if the person has Stevens-Johnson syndrome, severe liver disease, severe anaemia, severe pancytopaenia, or HIV negative
status.

CPT contraindications: severe allergy to sulfa drugs; severe liver disease, severe renal disease, and glucose-6-phosphate
dehydrogenase (G6PD) deficiency and in these conditions DO NOT re-challenge

SP = Sulfadoxine/Pyrimethamine WCS = WHO Clinical Staging

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MANAGING THE HIV PROGRAM
SERVICE DELIVERY

Recommendations

Diversify interventions to ensure timely linkage to HIV Services

Patient-centeredness to allow for delivery of care based on people’s

needs, preferences, clinical characteristics, and context

Special considerations for Priority and Key Populations

Task-shifting and investment in staff training and development

Service delivery should be across the HIV continuum of care

Establish effective systems for monitoring patients in care

The Ministry of Health recommends Comprehensive HIV care which involves services that are integrated into the overall delivery of
Health Services in Health facilities. This integrated model works closely with the recipients of care resulting in services that are
efficient and responsive to the needs of the community. These services should be accessible at all levels of care starting from the
community. This is within the Ministry of Health Primary Health care framework.

These services are delivered by trained cadres across the whole spectrum from community to the Health facility. The ideal team
consists the following as shown in Figure 28 below:

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F I G U R E 28: H U M A N R E S O U R C E M A N A G E M E N T IN THE ART C L I N I C

Health Facility In-Charge

HTS In-charge Lab In-charge ART In-charge Pharmacy In-charge MCH In-charge Information Officer TB In-charge

Psychosocial Lab Clinicians: Pharmacists, Data Associates Clinicians:

MCH Nurses
Counsellors Technologists MOs, COs, Pharmacy MOs, COs,
and Midwives
MLs, HNPs Technologists MLs
Lay Data Entry
Counsellors Staff VL Champion EID Champion Treatment
Supporters
Linkage
Appointment
escorts
Officer

Adherence
Support/Lay
Counsellors/
Volunteers/
Peers

COs = Clinical Officers; EID = Early Infant Diagnosis; HNPs = Health Nurse Practitioners; MCH = Maternal and Child Health; MLs = Medical Licentiates; MOs = Medical Officers

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Following diagnosis and throughout the spectrum of care, HIV services should be tailored to respond to specific challenges or
barriers faced by patients and aim to offer high quality care, client satisfaction and improved health outcomes. In order to ensure
timely linkage to care and follow up for all people living with HIV, a package of differentiated interventions should be offered to
clients.

F I G U R E 29: HIV I M P L E M E N T A T I O N C A S C A D E FOR THE CONTINUUM OF CARE

HIV

Virological
Testing Diagnosis HIV Care Treatment
Suppression

Linkage Engagement/Retention

The Ministry of Health (MoH) of the Republic of Zambia is committed to achieving the 90-90-90 targets and is aware that innovative
strategies are needed in order to end the HIV epidemic. Critical to this is to ensure the provision of HIV treatment to all. Continuing
to provide services in the same way for all clients will not allow for the achievement of reaching 90-90-90 targets. MOH is aware that
the conventional human resources and physical infrastructure currently are not adequate to accommodate national scale up of ART.

Differentiated service delivery (DSD) is a client-centered approach that simplifies and adapts HIV services across the cascade in
order to reflect the preference and expectations of various groups of PLHIV while also reducing unnecessary burdens on the health
system.

The MOH supports the promotion and provision of various differentiated service delivery models in order to lessen the burden of care
for both patients and providers and to allow the health system to refocus resources on those patients in most need

PRINCIPLES OF DIFFERENTIATED CARE

The principles of DSD are aimed at supporting the achievement of 90-90-90 targets while also improving the quality of care clients
receive.

Implementation of DSD models should be guided by the following principles;

• Adequate and consistent supply of ARVs and health commodities
• Trained healthcare workers (HCWs) and community volunteers
• Monitoring and Evaluation (M&E) systems
• Informed consent
• Human rights and dignity
• Quality of care and good clinical practice
• Integration
• Client-Centered
• Controlled Flexibility
• Community engagement

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BUILDING BLOCKS OF ART DIFFERENTIATED SERVICE DELIVERY
MODELS
The building blocks are key components of a service delivery model and address the ‘when, where, who, and what’ of HIV services
and should be used for whichever characteristic(s) (clinical, specific, populations, context) are being considered. At each step in the
treatment cascade, DSD models should be designed and implemented as a direct response to specific challenges or barriers
identified for clients and health care workers.

Patient Classification for Differentiated Services Delivery

DSD should be provided to all PLHIV across the HIV cascade and extended to other diseases. A growing number of people receiving
ART are virally suppressed (stable) and do not require frequent visits to the Health Facility. Offering DSD models of care reduces the
burden of frequent visits to the facility for stable clients and allows for resources to be redistributed to patients most in need.

Stable client is defined as follows;

• On ART for at least 6 months

• No adverse drug reactions
• No current illnesses or pregnancy
• Proven record of good adherence and evidence of treatment success
• Viral suppression < 1000 copies/mL within the last 12 months

Unstable client is defined as follows;

• On ART for < 6 months
• On ART for ≥ 6 months but presenting with advanced HIV disease
• CD4 < 200 cells/µL
• WHO stage 3 or 4 event
• All children younger than five years old with HIV are considered as having advanced HIV disease

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 • Not virally suppressed
• Advanced immunosuppression
• Adverse drug reactions
• Active opportunistic infection
• Non-adherent to ART
• Substance use
• Mental illness
• Any other uncontrolled chronic condition/comorbidity like NCDs

Categories of DSD

DSD models can be categorized into four models: (www.differentiatedcare.org)

1. Healthcare worker managed Group:

• Clients receive their cART refills in a group and either a professional or a lay health care worker manages this
group (e.g., Urban Adherence Groups/Clubs) Health care worker-managed groups meet within and/or outside of
health care facilities.

2. Client Managed Groups

• Clients receive their cART refills in a group but this group is managed and run by clients themselves (e.g.
Community Adherence Groups (CAGs). Generally, client- managed groups meet outside of health care facilities.

3. Out of Facility Managed Individuals

• cART refills and are provided to individuals outside of health care facilities (e.g., of Health Post Dispensation, Home
delivery and Community based drug pick-ups)

4. In-Facility Managed Models

• cART refill visits are separated from clinical consultations. When clients have a cART refill visit, they bypass any
clinical staff or adherence support and proceed directly to receive their medication (e.g., appointment spacing and
“fast-track”)

RECOMMENDATIONS FOR IMPLEMENTATION FOR DSDS

These guidelines recommend that all stable patients should be on MMD (Multi-Month Dispensation) defined as dispensing of ARV’s
for 6 months

1. Clinical reviews for stable patients should be every 6 months with rational appointment systems

TB PROPHYLACTIC THERAPY IN THE SETTING OF DSD’S IN STABLE CLIENTS

2. The HIV care DSD Schedule should not be interrupted when stable clients are being commenced on TB prophylactic therapy,
(TPT). However, these clients should receive the TPT separately from the ART schedule as per the National TPT guidelines.
The TPT visits should be synchronized with pharmacy pickups and clinical follow ups to avoid patients having multiple visits

DSD for Unstable Clients

There is limited evidence on the building blocks and models for unstable clients however, these clients may also benefit from DSD
model access in supporting viral suppression and improving retention. Therefore, DSD building blocks and models should be adapted
to accommodate all PLHIV

Principles of DSD for Specific Populations (children, adolescents, pregnant and breastfeeding women)
1. Family based Approach

Important when considering care for children and their parents. Service provision models for children and their
parents/caregivers should be aligned as this can improve the entire family cascade.

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2. Integration of Services

Integration of HIV care with other services is a WHO recommendation to strengthen the continuum of treatment care. Integration
has been highlighted as key to providing benefits to mothers and their infants, and combining adolescent HIV services with
comprehensive services.

3. Leveraging and encouraging psychosocial support

The importance of psychosocial support for all PLHIV, including support from communities and peers, is of particular significance
to these special populations

Approach of DSD model to be offered at any given facility should consider:

• Clinical Characteristics of the client (stability, unstable, co-morbid/co infections)

• Client preference
• Model available at the facility

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T A B L E 42: C A T E G O R I Z A T I O N OF SERVICES OFFERED AT DELIVERY POINTS

HIV/AIDS Management

• At facility level are “high risk,” i.e., Pregnant and breastfeeding women, HEI, discordant couples, newly
diagnosed/initiated patients
• Community services to focus on “stable” patients

Community structures such as: Community Facility: Health Centre, Level 1, Level 2, Level 3, and Level 4
Adherence Groups (CAGs), Treatment Clubs, Private
sector, Faith based groups, Health shops, etc.

Decentralization of Services Diagnostic and Clinical Services

Retention in Care: Health Centre:

• PMTCT sites should have functional community • HIV testing at birth, 6 weeks, 6 months, 9 months, 12 months, 18
months, 24 months and across all populations (see Table 1)
structure/groups affiliated with timely support and
• Triple prophylaxis depending on risk assessment
connection between health facility and • Co-trimoxazole (CTX)
community • Growth monitoring
• Immunization as per EPI schedule
• Interventions of mother-baby follow up through • Clinical review and follow up
reminders for appointments, adherence support • Infant feeding counselling
• Ongoing HIV/AIDS counselling and screening.
• Community workers and message on identifying
• Uptake of newly diagnosed cases and commence ARVs
sick infants and sending to facilities • Treatment of OIs as per Standard Treatment Guidelines
• Use of current interventions to follow up patients • Palliative care (pain relief and management of common illnesses)
and infants (e.g., nutritional assessment and
DBS sample collection)
Task Shifting and Sharing: Level 1:

• Less frequent clinical visits (3-6 months) being All of the above and:
recommended for people stable on ART. • Clinical review/examination
• FBC, CXR, HIV +/-CD4 count, U+E, Creatinine, urinalysis,
• The use of Community ART models for pick- up
treatment, and follow up management of OIs
of ART, while initiation and monitoring at
• Infant feeding counselling If referred for further management
peripheral health facilities with maintenance at
• Acceptance of referral back and joint management
community level
• Trained and supervised community health Level 2:
workers can dispense ART between regular
All of the above and:
clinical vests
• Management of severe symptoms and investigations
• Urine protein creatinine ratio
• LFTs

Level 3:
• VL and genotype for treatment failures
• Metabolic complications management
• Research 3rd line management
• Triple prophylaxis depending on risk assessment
• Highly specialized research
• CTX prophylaxis
• Complicated cases:
§ HIV plus co-morbidities

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MONITORING AND EVALUATION

Recommendations

Use of data for decision making

Use of a single System for Monitoring and Evaluation (M & E)

Use of Electronic Health System

In order to efficiently and effectively monitor the provision of HIV Care and Treatment, there is need to ensure that patient information
is documented based on the services that may have been provided. This information is crucial for planning and decision making.
Ministry of Health has a number of HIV data collection tools developed and in use across the country. Data is collected either through
paper or electronic health record system (EHR) depending on which system is available at the facility level or service delivery point.
Health Facilities are urged to use only one system (Paper Based or EHR/SmartCare) and not both at the same time.

Monitoring and Evaluation Data Collection Tools

There are many data management tools to assist facilities in recording comprehensive, family-centred HIV Care and Treatment.
Some of the standard HIV data collection and patient care tools include:-

• HIV Testing Services (HTS) Register

• Antenatal Care Register
• Labour and Delivery Register
• Postnatal Care Register
• EID Register
• Intergrated MCH Register (0-23 months)
• Intergrated MCH Register (24-59 months)
• HIV Care and Treatment Activity Register
• HIV Care and Treatment Monthly Register
• Daily Activity Register (DAR for Phamacy)
• PrEP_PEP Register
• IPD Register
• OPD Register
• VMMC Register
• STI Regsiter
• HIV Self Testing Distribution register
• Facility/Lab Viral Load Register
• Family Planning Register

All these tools have corresponding collation froms (activity and tally sheets). Wherever feasible, data regarding the continuum of HIV
care and treatment should be entered into an EHR system (SmartCare). In addition, all facilities should record birth defects using the
forms obtainable from the Zambia Medicines Regulatory Authority (ZAMRA,) to feed into the National Birth Defects Registry.

Use of standard tools is required by all health facilities to ensure a functioning supply chain system to avoid stock outs.

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The recommended standard tools include:

• Report and Requisition (R&R) form

• Daily Activity Register
• Interval Monthly Summary Report
• Stock Control Cards
• Laboratory Usage report
• Report for Essential Medicines and Medical Supplies.

HIV Diagnosis

The HIV testing services have been integrated into the general routine health care services. Registers have been revised to allow
the recording of the HIV testing at every designated service delivery point with all the HIV testing results recorded in the registers for
the testing service provided. For instance, clients tested during OPD should be recorded in the OPD registers (with results entered).

HIV Care and Treatment

When providing HIV Care and Treatment, the first data collection tools to be used are the ART Forms. These forms will form the
Recipient of care/ Client / Patient File. The following are some of the forms to be filled include; Patient Locator, Initial History and
Physical, Clinical Follow Up, Short Visit, Patient Status Form, Stable on Care, Missed Visits, Referral Form, HIV Summary Sheet and
Pharmacy. The forms are in both electronic and paper forms.

After filling of the ART forms, the various registers supporting Care and Treatment will be updated together with Tally Sheets, Activity
Sheets and Summary Forms deepening on the system facility is using. For Paper based, the forms are used to update the registers
while for electronic Systems, the registers are auto created and updated in the EHR system.

Paper-Based System

Under this system, recipient of care/client/patient information is generated manually using paper documents that is forms, registers
and Health Information Aggregation form 2/3.

Upon provision of a service (on a daily basis), a facility is expected to fill in the ART forms. In return, the ART forms should be used
to create and update the various registers mentioned above. At the end of each month, a facility is expected to compile the Health
Aggregation Form (HIA2/3) on HIV Testing, Care and Treatment from the registers and send the HIA forms the District Health Office
for entry in the District Health Information System (DHIS2). In some instances, data entry is done at facility level and are only expected
to send HIA 2/3 to the DHO for verification supposes.

Electronic Health Record (EHR) System

Under this system, recipient of care/client/patient information is entered in an electronic system (SmartCare). SmartCare is a fully
integrated electronic health record system tracking the provision of continuity of care; it is a clinical management information system
at the facility and district (management/administration) level and it’s a key component in 'one National M&E system'.

In relation to data entry, SmartCare uses different modes of implementation such which are; E-Last, E-Fast and E-First. E-last involves
entering data after seeing all clients (transfer from Paper records to electronic) E-fast involves entering data just after seeing client
while E-first involves real -time data entry by provider(s). The EHR system is intergrated to other systems such as the Case Based
Surveillance system to track the HIV epidemic.

At the end of each month, the facility should ensure that all the information of the clients is entered and no backlog. Thereafter,
various reports can be generated in SmartCare which may include the Health Aggregation Forms (HIA2/3), PEPFAR MER Reports,
Daily Activity Register, ART Monthly Register among others. Thereafter, Transport Data Base must be sent to the District for merging
with other data from other facilities and for further Submission to the province and national level for merging.

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Below is the Data flow guideline from Community to National level:

F I G U R E 30: H E A L T H M A N A G E M E N T I N F O R M A T I O N S Y S T E M D A T A F L O W G U I D E L I N E

Aggregate
From District to MoH
(7th to 21st of the 2nd
Action Triple “A”
month)
MoH HQ
Analysis
Analysis

Aggregate

Action Triple “A”

Province
From District to Analysis
th st
Province (7 to 21 of Analysis
the 2nd month)
Aggregate

Triple “A”
District Action
Analysis

Analysis
From Health Facility to
District (2nd to 7th of
Aggregate
the 2nd month)
Triple “A”
Facility Action
Analysis

Analysis
From Community to
Aggregate
Health Facility (2nd to
7th of the 2nd month) Triple “A”
Community Action
Analysis

Analysis

Quality Improvement
Quality Improvement (QI) is a process that aims to strengthen the quality of services provided at health facilities. The QI Technical
Working Group (TWG) at MOH has identified five key QI indicators that will be tracked by all levels in the health sector. Of the five
indicators, two are HIV-related:

• Percentage of exposed infants tested for HIV at 9 months old

• Percentage of all HIV positive clients retained on HIV care and treatment the last 12 months
o Number of HIV testing sites scoring ≥80% in proficiency testing
o Number of EID testing labs scoring ≥80% in proficiency testing
o Number of viral load testing labs scoring ≥80% in proficiency testing
o Number of labs enrolled in the CD4 External Quality Assurance (EQA) program scoring ≥80% in proficiency testing

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Lifelong ART in pregnant and breastfeeding women also enhances maternal and child survival. For this reason, the following two QI
indicators are also pertinent:

• Number of maternal deaths at the facility recorded in the last 1 month, 3 months (quarter), and 12 months
• Number of under-five children who died in the last 1 month, 3 months (quarter), and 12 months. (If possible, differentiate between
early neonatal death, neonatal death, infant death, and under-five death)

Through structures that have been formed at all levels, the QI committees review these indicators regularly to identify performance
gaps and root causes using the Performance Improvement Approach (PIA). This should be followed by implementation of appropriate
interventions coupled with regular monitoring and evaluation to track progress.

These indicators will be reported through the Health Management Information System (HMIS), as well as tracked through the QI
reporting structures from the health facility to the national level QI TWG. QI committees at any level should not be restricted to
implement QI projects only related to the key indicators. Other areas of underperformance in health service delivery should be covered
at the local level as identified with stakeholders, including clients and the community.

Mentoring and Supervision

Mentorship is a QI strategy that provides motivation to HCWs while building their knowledge and skills base.

In collaboration with cooperating partners, MoH developed national guidelines and a mentorship training package. The multi-
disciplinary Clinical Care Teams (CCT) at national, provincial, and district level spearhead mentorship and supervision of health
facility staff. CCTs comprise clinicians, nurses, nutritionists, pharmacy staff, and laboratory staff and hold regular meetings to review
HMIS reports, performance assessment reports, and any other source of information to identify performance gaps in health service
delivery, including HIV care and treatment and PMTCT. Appropriate mentors are assigned from the CCT to conduct targeted, needs-
based mentorship for QI. Request for specialized mentorship from higher level CCTs is encouraged. The multi-disciplinary approach
achieves the following:

• Comprehensive coverage of clinical and support systems, including logistical and health information management
• Coordination, continuity, and availability of a pool of highly experienced mentors in the relevant fields
• Strengthened institutionalized, decentralized system of mentorship

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APPENDIX 1: D OSAGES OF A NTIRETROVIRALS FOR
A DULTS AND A DOLESCENTS
a) D O S A G E S OF ANTIRETROVIRALS FOR ADULTS AND ADOLESCENTS

Drug Normal Dose Renal Dose

Adult: 300mg BD PO
Abacavir (ABC) No adjustment
Paediatrics: 8mg/kg BD PO

Adult: 300/100mg OD PO
Atazanavir─r Paediatrics: paediatric dosing by weight bands. No adjustment
No data for children <6 years old.

Adult: 600/100mg BD PO
Darunavir─r No adjustment
Paediatrics: see paediatric dosing by weight bands.
Do not use in children <3 years old.

Adult: 50mg OD PO
Dolutegravir (DTG) No sufficient data for use in adolesents younger than No adjustment
10 years old

Efavirenz (EFV) Pregnant and/or breastfeeding: 400mg OD PO No adjustment

600mg OD PO

Adult: 200mg OD PO Adult:

CrCl 30-49: 200mg every 48 hours
Pediatrics: CrCl 15-29: 200mg every 72 hours CrCl <15:
0-3 months old: 3 mg/kg/day (solution) 200mg every 96 hours
Emtricitabine 3 months-15years old (>33kg): 6mg/kg/day (give after hemodialysis if on dialysis)
(FTC) (solution; max 240mg daily) or capsule: 200mg
OD (capsule) Paediatrics: reduce dose or increase dosing
interval following adult recommendations in
consultation with experienced clinician in renal
dosing

Adult: 200mg BD PO

Paediatrics: see paediatric dosing by weight bands.

Not approved for children <6 years old (approval
under way for 2 months to 6 years old). No adjustment
Etravirine (ETR) • 16kg-<20kg: 100mg twice daily
• 20kg-<25kg: 125mg twice daily
• 25kg-<30kg: 150mg twice daily

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 Drug Normal Dose Renal Dose

Adults:
CrCl 30-49: 150mg OD PO
CrCl 15-29: 150mg x1 then 100mg OD PO
CrCl 5-14: 150mg x 1 then 50mg OD PO CrCl
Adult: 150mg BD or 300mg OD PO <5: 50mg x1 then 25mg OD (50- 75mg OD still
acceptable)
Lamivudine (3TC)
Paediatrics: 2-4mg/kg BD PO
Paediatrics: reduce dose or increase dosing
interval following adult recommendations in
consultation with experienced clinician in
renal dosing

Adult: 400/100 BD PO
No dose adjustment, but use with caution in
Lopinavir─r patients with CrCl <50
Paediatrics: 10-13mg/kg BD PO for Lopinavir
component

Adult: 200mg OD PO x 14 days then 200mg BD PO

Nevirapine (NVP) No dose adjustment, but give dose after dialysis
Paediatrics: 4-7mg/kg BD PO

Adult: 25mg OD PO
Tenofovir
alafenamide (TAF) Paediatrics: not approved for adolescents less than 10 No adjustment
years old

Same for adult & paediatrics:

NOTE: Generally, avoid when CrCl <50 Only

adjust dose when sure that the CKD is
independent of the drug in consultation with
experienced clinician in renal dosing.

CrCl 30-49: 300mg (8mg/kg) every 48

hours
Tenofovir (TDF) Adult: 300mg OD PO Paediatrics: 8mg/kg OD PO
CrCl 10-29: 300mg (8mg/kg) twice weekly

CrCl <10: consider 300mg (8mg/kg) OD

PO (inadequate data) Hemodialysis:
300mg (8mg/kg) once weekly. To be given
after dialysis.

CAPD: no data

Adult: 400mg BD PO (with Rifampicin 800mg BD PO)

Raltegravir (RAL) No dose adjustment
Paediatrics: see paediatric dosing by weight bands.

CrCl 30-49: 300 BD PO

Zidovudine (AZT) Adult: 300mg BD PO CrCl 10-29: 300 BD PO
Paediatrics: see paediatric dosing by weight bands. CrCl <10: 300mg OD PO in consultation with
experienced clinician in renal dosing

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 b) P A E D I A T R I C ARV D O S A G E S BY WEIGHT BAND

Strength of
≥35kg
3-5.9kg 6-9.9kg 10-13.9kg 14-19.9kg 20-24.9kg Adult tablet 25-34.9kg
Adult dosing
(mg)
AZT/3TC
1 tab BD 1.5 tabs BD 2 tabs BD 2.5 tabs BD 3 tabs BD 300mg/150mg 1 tab BD 1 tab BD
Dual drug Fixed 60mg/30mg
dose Combination ABC/3TC
1 tab BD 1.5 tabs BD 2 tabs BD 2.5 tabs BD 3 tabs BD 300mg/150mg 1 tab BD 1 tab BD
60mg/30mg
1 tab
morning
AZT 300mg nr nr nr 0.5 tab BD 300mg 1 tab BD 1 tab BD
0.5 tab
evening
5 - 7.5kg
3.5 - 5kg 7.5 - 13.9kg
EFV 200mg 0.75 tab 1.5 tabs daily 1.5 tabs daily 200mg 2 tabs daily 2 tabs daily
0.5 tab daily 1 tab daily
daily
1 tab
morning
ABC 300mg nr nr nr 0.5 tab BD 300mg 1 tab BD 1 tab BD
0.5 tab
evening
1 tab
morning
3TC 150mg nr nr nr 0.5 tab BD 150mg 1 tab BD 1 tab BD
0.5 tab
evening
1 tab 1 tab
morning morning
NVP 200mg nr nr 0.5 tab BD 0.5 tab 0.5 tab 200mg 1 tab BD 1 tab BD
evening evening

LPV-r oral
Solution 1 mL BD 1.5 mL BD 2 mL BD 2.5 mL BD 3 mL BD -- -- --
80mg/20mg/mL

LPV-r*capsules 2 capsules 3 capsules 4 capsules 5 capsules 6 capsules -- -- --

40mg/10mg BD BD BD BD BD
2 tabs 2 tabs
LPV-r morning 1 morning 1
nr nr nr 1 tab BD 200mg/50mg 2 tabs BD
200mg/50mg 1 tab 1 tab
evening evening
ATV-r
nr nr nr nr nr 300mg/100mg nr 1 tab daily
300mg/100mg

RAL*
400mg
Chewable nr nr nr 1 tab BD 1.5 tabs BD 1 tab BD 1 tab BD
coated tablet
100mg tablet

DTG 50mg 50mg nr 1 tab daily

tablet

TAF 25mg 25mg nr 1 tab daily

tablet

nr = Not recommended
Refer to adult doses for all children 35 kg and above
Using LPV-r oral liquid should be avoided in premature and term babies until 14 days after their due date
*Raltegravir suspension will not be available
*LPV-r capsules 40mg/10mg for paediatric use only (3-24.9 kg). For children < 3 kg refer for expert management
*Capsules = The LPV-r capsules have pellets inside
Use of TAF in pregnancy not yet conclusive
In TB co-infection, LPV-r and RAL is double dosed, DTG is given twice daily, while TAF use is still not conclusive

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APPENDIX 2: K EY D RUG -D RUG I NTERACTION FOR
ARV S
ABC TDF AZT 3TC FTC d4T ATV LPV RTV EFV NVP DTG RAL

Antibiotics (incl. TB drugs)

Rifampicin
Rifabutin
Bedaquiline
Antimalarial drugs

Amodiaquine
Artemisinin
Halofantrine
Lumefantrine
Antifungal
Itraconazole
Ketoconazole
Antiretrovirals
Efavirenz
Etravirine
Nevirapine
Emtricitabine
Zidovudine
Lamivudine
Stavudine
Atazanavir
Darunavir
Lopinavir
Abacavir
Ritonavir
Dolutegravir
Gastrointestinal Agents
Omeprazole
Esomeprazole
Lansoprazole
Cardiovascular drugs
Quinidine
Simvastatin
Amlodipine
Enalapril
Hydrochlorothiazide
Anticonvulsants
Carbamazepine
Phenytoin

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COLOUR CODES FOR THE KEY DRUG–DRUG INTERACTIONS FOR ANTIRETROVIRAL DRUGS

No clinically significant interaction or interaction unlikely based on knowledge of drug metabolism.

Potential interaction that may require close monitoring, alteration of drug dosage or timing of administration.

Interaction likely: do not use or use with caution.

No clear data, actual or theoretical, indicate whether an interaction will occur.

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APPENDIX 3: WHO T OXICITY E STIMATES
Grade (Severity) Characteristics Management

1 - Mild Transient or mild discomfort, no limitation in Does not require change in therapy
activity, no medical intervention needed Symptomatic treatment may be given

2 - Moderate Limitation in activity, some assistance may be Consult

needed, no or minimal medical intervention or
Continue ART if possible
therapy required
If no improvement, consider substitution with a
drug in the same ARV class, but with a different
toxicity profile

3 - Severe Marked limitation in activity, some assistance Refer or consult

usually required, medical intervention required,
Substitute the offending drug without stopping
possible hospitalization
therapy
4 - Life-threatening Extreme limitation in activity, significant Discontinue all ARV drugs, manage the medical
assistance required, significant medical event until patient is stable and toxicity has
intervention or therapy required, hospitalization resolved
or hospice care

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

APPENDIX 4: C O -T RIMOXAZOLE D ESENSITIZATION
P ROTOCOL F OR A DOLESCENTS A ND A DULTS
Time Point Dose for desensitization
Day 1 80mg SMX/16mg TMP (2mL of oral suspension)

Day 2 160mg SMX/32mg TMP (4mL of oral suspension)

Day 3 240mg SMX/48mg TMP (6mL of oral suspension)

Day 4 320mg SMX/64mg TMP (8mL of oral suspension)
Day 5 1 single-strength SMX/TMP tablet (400mg SMX/80mg TMP)
Day 6 onward 2 single-strength SMX/TMP tablets or one double strength tablet (800mg SMX + 160mg TMP)

Oral suspension is 40mg TMP/200mg SMX per 5mL of syrup

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APPENDIX 5: P OSITIVE H EALTH D IGNITY &
P REVENTION (PHDP)
To have a significant effect on slowing the spread of the epidemic, prevention efforts must also be directed towards HIV-infected
individuals who can transmit the virus.

Deliver consistent, targeted prevention messages and strategies during routine visits

At every visit, assess for and counsel regarding:

• High risk sexual activity

• Partner’s and children’s HIV status
• Disclosure to partner/guardian/treatment supporter
• Signs and symptoms of STIs and cervical cancer
• Pregnancy status
• Adherence to ART and other medications
• Abuse of alcohol and other substances
• Positive living (nutrition, alcohol and smoking cessation)

Six (6) key steps for PHDP:

• Step 1: Give risk reduction messages to every patient at every visit

• Step 2: Assess adherence to ARVs
• Step 3: TB and STI screening and management
• Step 4: Family planning services and safer pregnancy counselling
• Step 5: Give patient condoms at every visit
• Step 6: Partner HIV testing

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APPENDIX 6: R ENAL INSUFFICIENCY SCREENING
ALGORITHM ( IN THE ABSENCE OF C REATININE TEST )

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Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection

APPENDIX 7: F ORMULAE FOR CALCULATING
C REATININE C LEARANCE IN DIFFERENT PATIENT
POPULATIONS

IN CHILDREN (10-18 YEARS) GLOMERULAR ADULTS (≥19 YEARS)

FILTRATION (SCHWARTZ)
• For Men:
Clinical Use: A simple estimate of Glomerular Filtration Rate
in children derived from body length and serum Creatinine. [(1234.)')(5'()&* (/ #))]
CrCl = 78 9 :'-;< ,-'.*(/(/' (<)/>?)

Formula: OR
[(1234.)')(5'()&* (/ #))]
(# × &'()&*) CrCl = 3.A1B 9 :'-;< ,-'.*(/(/' (C<DE/?)
Creatinine Clearance =
,-'.*(/(/'

• For Women
[(1234.)')(5'()&* (/ #))(3.AB)]
CrCl =
78 9 :'-;< ,-'.*(/(/' (<)/>?)

OR

[(1234.)')(5'()&* (/ #))(3.AB)]
CrCl = 3.A1B 9 :'-;< ,-'.*(/(/' (C<DE/?)

Units:

• Creatinine: [mg/dL] mg/dL=88.4µmol/L

• Height: [cm]
• Constant as follows: 0.55 for adolescent girls and 0.7 for adolescent boys
• For pregnant women use serum Creatinine (should be less than 125µmol/L to use TDF

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GLOSSARY
Antiretroviral Therapy (ART): Use of antiretroviral regimens consisting of a combination of at least three or more drugs from at
least 2 classes

Body Mass Index (BMI): A measure of body fat based on one’s weight in relation to height

Co-trimoxazole Preventive Therapy (CPT): Use of Co-trimoxazole to prevent opportunistic infections in susceptible Persons
Living With HIV/AIDS (PLWHA)

Creatinine Clearance (CrCl): An estimation of milliliters of blood filtered by the kidneys per minute

Directly Observed Therapy short course (DOTs): refers to the WHO-recommended strategy for TB control and involves direct
observation of patients taking TB medications. This is done to ensure that the patient takes the right medicines, in the right doses,
at the right intervals.

Focused Antenatal Care (FANC): A standard package of basic ANC services that all pregnant women should receive. FANC
emphasizes the importance of developing a plan of care that meets each woman’s individual needs.

HIV Testing Services (HTS): Refers to the full range of services provided with HIV testing, including counselling; linkage to
appropriate HIV prevention, treatment, and care, and other clinical services; and coordination with laboratory services to ensure
delivery of accurate results

Isoniazid Preventive Therapy (IPT): Use of Isoniazid for prophylaxis to susceptible patients to offer protection against
Mycobacterium TB

Immune Reconstitution Inflammatory Syndrome (IRIS): An exaggerated inflammatory reaction from a re-invigorated immune
system

National Unique Patient Number (NUPN): A unique client identification number used in SmartCare patient records system

Nucleic Acid Test (NAT): Virological testing technology used for early infant HIV diagnosis developed and validated for use at the
point of care. This test detects both viral RNA and DNA

Polymerase Chain Reaction (PCR): A test done to detect HIV specific genetic material that indicates presence of HIV. In Zambia,
through the use of Dry Blood Spot (DBS) specimen, this test diagnoses HIV infection in children below 18 months of age.

Positive Health Dignity and Prevention (PHDP): An HIV prevention strategy among PLWHA that focuses on: risk reduction, ART
adherence, correct condom use, family planning, STI screening, and partner HIV testing

Pre-exposure Prophylaxis (PrEP): An HIV prevention strategy where those at high risk of acquiring HIV are covered on
prophylactic ARVs before exposure to the HIV virus

Post-exposure Prophylaxis (PEP): Short term antiretroviral treatment to reduce the likelihood of HIV infection after potential
exposure to the virus

Severe Liver Disease: Progressive destruction of the liver parenchyma over a period greater than 6 months leading to fibrosis and
cirrhosis

Treatment as Prevention (TasP): Refers to use of antiretroviral therapy in PLWHA to decrease the risk of HIV transmission to
others

Treat All: WHO recommendation that all clients testing HIV positive should be initiated on ART irrespective of their WHO Clinical
staging, CD4 or Viral load levels

Visual Inspection with Acetic acid (VIA): A cervical cancer screening method done using Acetic acid

127 | Glossary

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Zambia Consolidated Guidelines
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