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HIVST and PrEP community consultation
- 1. WHO consultation onHIV self- testing and PrEP Dr Rachel Baggaley and Dr Busisiwe Msimanga-Radebe, WHO http://www.who.int/hiv/en/ www.hivst.org 10 August 2017 WHO Meeting – Pretoria, South Africa
- 2. HIV testing andcare continuum (2016) UNAIDS/WHO estimates The testing gap >30 % people unaware they are living with HIV Inequity continues - men, adolescents and key populations
- 3. Reactive results needconfirmation by trained tester using a validated national algorithm What is HIV Self-Testing? Collects Performs Interprets
- 4. WHO HIVST Strategy •self-testers with a reactive (positive) result need further testing from a trained provider • self-testers with a non-reactive (negative) test result should retest if they have been exposed to HIV in the preceding six weeks, or are at high ongoing HIV risk. • HIVST is not recommended for people taking anti-retroviral drugs, as this may cause a false non-reactive result. *Any person uncertain about how their self-test result, should be encouraged to access facility- or community-based HIV testing
- 5. Directly assisted HIVself-testing Trained peer or health worker could provide a brief demonstration on how to use the kit and how to interpret results • Provide face-to-face assistance during self-testing (optional) • Instruction-for-use &/or included in the kit: ‒ Pictorial/written ‒ Including a hotline number or a link to a video ‒ Multimedia instructions (tablet) ‒ Remote support via SMS, QR code or mobile messaging applicationsUnassisted HIV self-testing Instruction-for-use included in the kit: • Pictorial/written • Including a hotline number or a link to a video • Multimedia instructions (tablet) • Remote support via SMS, QR code or mobile messaging applications • Package inserts included in the kit
- 6. WHO Guidelines onHIVST- December 2016 5 RCTs (2012-2016) directly comparing HIVST to HIV testing by a provider as of July 2016 25 studies on HIV RDT for self-testing performance as of April 2016 • 125 studies on acceptability/feasibility (including user values preferences) as of July 2016 • 4 studies on cost/cost-effectiveness as of July 2016
- 7. 5% 1% 10% 16% 33% 36% 0% 20% 40% Multi-Region SEAR EUR WPR AMR AFR Region 3% 32% 32% 40% Youngpeople General Population Other (Mixed, HCW) Key Population 0% 20% 40% 60% Population Studies by Region, Population, Type of RDT 13% 7% 67% 13% Null & N/A Fingerstick Oral fluid Oral fluid & Fingerstick Type of RDT
- 8. Advantages of HIVST •Empowering • Highly acceptable – to a range of populations – inc men, partners, adolescents and young people, key populations • Feasible and accurate • Increases uptake and access to testing • Increased frequency of testing • Good linkage to care can be achieved • No identifiable increased risk of social harm & adverse events
- 9. New WHO recommendation HIVself-testing should be offered as an additional approach to HIV testing services (strong recommendation, moderate quality evidence)
- 10. Where we arenow • Availability • Experience • Policy • Future plans
- 11. HIV self testingis available “informally” everywhere and formally in some countries
- 12. HIVST products (ERP-D &WHO PQ) Oral fluid HIVST pre-qualified July 2017 Blood-based HIVST in the pipeline
- 13. As of June2017, 40 countries have a supportive policy for HIVST, and 48 countries are planning to introduce HIVST as part of their national strategic plans
- 14. Key messages forusers and implementers Community awareness of the benefits and cautions about HIVST • Use of approved HIVST kits • with appropriate, validated, clear and concise instructions for use – demonstrations and support tools may be particularly useful for rural populations and those with low levels of education and literacy • Clearly state positive results need further testing, provide information on what to do after positive result • Clearly state that HIVST should never be used when people are taking ARVs (problem of false negative results) • Make sure pre-test information and post-test counselling accessible and available – inc linkage to community groups and clinical services • Some people will find HIVST difficult (esp initially) - Clear information about what to do if someone can’t do a HIVST or get a invalid result
- 15. Key messages forusers and implementers Community awareness of the benefits and cautions about HIVST • Integrate HIVST into comprehensive sexual health service programmes and provide messages and information on tuberculosis, STIs, viral hepatitis • Realize demand creation role of HIVST for PrEP, ART and other services • HIVST (as for all testing) must be voluntary, coercion never warranted • Monitoring of any abuses of HIVST or adverse outcomes essential
- 16. Next steps Increasing communityawareness How to do this • Events • Media • Literature, leaflets…… other Which methods most appropriate in SA Which groups need special focus • Further information • http://www.who.int/hiv/en/ • www.hivst.org
- 17. WHO recommendation forPrEP Oral PrEP (containing TDF) should be offered as an additional prevention choice for people at substantial risk of HIV infection as part of combination prevention approaches • Enabling recommendation • Not population specific – For people at substantial HIV risk (provisionally defined as HIV incidence > 3 per 100 person–years in the absence of PrEP) • Offer as an additional prevention choice • Provide PrEP within combination prevention – Condoms and lube – Harm reduction – HIV testing and links to ART • Provide PrEP with comprehensive support – Adherence counselling – Legal and social support – Mental health and emotional support – Contraception and reproductive health services
- 18. 18 Why more focuson prevention options needed Global HIV transmission persists Treatment scale-up has ‘masked stagnation in the estimated annual number of new HIV infections’ . Beyond the 90-90-90: refocusing HIV prevention as part of the global HIV response Baggaley R, Dalal S, Johnson C, Macdonald V, Mameletzis I, Rodolph M, Figueroa C, Samuelson J, Verster A, Doherty M, Hirnschall G. J Int AIDS Soc. 2016 Dec Prevention Gap Report (UNAIDS), 2016: http://www.unaids.org/sites/default/files/media_asset/2016-prevention-gap- report_en.pdf
- 19. Behavioral Interventions WHO rec 2012 Partner/Couplestesting WHO rec 2011 ?testing Coates T, Lancet 2000 Sweat M, Lancet 2011 WHO rec 1995 Male and female Condoms & lubricants STI Treatment Grosskurth H, Lancet 2000 WHO rec 2007 VMMC (Male circumcision) Auvert B, PloS Med 2005 Gray R, Lancet 2007 Bailey R, Lancet 2007 WHO rec 2012 "Treatment as prevention" U=U Cohen M, NEJM, 2011 Donnell D, Lancet 2010 Tanser, Science 2013 Grant R, NEJM 2010 (MSM) Choopanya K, Lancet 2013 (IDU) WHO rec 2012,14, 15 Oral PrEP WHO rec 2007,14 Post Exposure prophylaxis (PEP) Scheckter M, 2002 HIV PREVENTION ?Mobile Technologies WHO rec 2004 NSP for PWIDs WHO rec 2000, 09 OST for PWIDs Kaplan, JAIDS, 1994 Allen S BMJ, 1992 HIV prevention
- 20. HIV testing New positives Negatives 'highrisk' 'Not interested' Negatives 'low risk' Negative Negatives 'high risk' interested in PrEP PrEP Engagement with services Condoms and lube, STI, HBV, HCV screening, re-testing , partner testing, vaccination, family planning, GBV issues tackle HIV stigma, educate about TasP PrEP services Re-engage positives Who dropped out of care A catalyst for much broader benefits beyond PrEP New ART initiation
- 21. PrEP not forall; not for ever Total population of people at substantial risk Seeks services 'meets criteria ' for offer of PrEP Accept PrEP Eligible for PrEP Starts PrEP Continue on PrEP Re-starts PrEP “Not using PrEP”: other HIV prevention option needed “Not using PrEP”: other HIV prevention option needed
- 22. WHO PrEP guidance PreventingHIV during pregnancy and breastfeeding in the context of PrEP Technical brief http://www.who.int/hiv/pub/toolkits/pr ep-preventing-hiv-during-pregnancy/en/ Who Implementation Tool for Pre-exposure Prophylaxis of HIV Infection Résumé des modules en Française
- 23. WHO PrEP ImplementationTool • Modular • Different audiences • Different setting • Different pops • Suggestions not recommendations • Much uncertainly • Learn as implement • Frequent updating anticipated
- 24. Concerns about PrEP Cost Equity Safety Drugresistance Behavioral disinhibition Pregnancy and hormonal contraception Evidence to support PrEP use…. Can be cost-effective (esp. if generic drugs used) and "PrEP candidate" appropriate. People at substantial HIV risk are often medically underserved and have few other effective HIV prevention options. No differences in any adverse events or grade 3 or 4 adverse events when comparing PrEP to placebo, but will need to monitor creatinine before and during PrEP use. Low levels <1 case in 1000 PY PrEP use. PrEP is expected to reduce HIV incidence, including primary and secondary drug resistance, thereby decreasing drug resistance overall. No evidence of changes in condom use or number of sexual partners as a result of PrEP use. No drug-drug interactions with hormonal contraception. No increased adverse pregnancy-related events. Key issues as we move from recommendation → implementation
- 25. • PrEP works,when taken (adherence is a critical predictor) • Demand is growing, although uptake varies according to setting • PrEP brings people at high HIV risk into services with benefits beyond PrEP – HIV testing uptake – Opportunity to screen for STIs, FP, vaccinate for HepB • Not all people want PrEP and not all the time. Other prevention must be available • To support effective and equitable PrEP use, services need to address structural factors and behavioural issues • PrEP is not just a biomedical intervention, but also a bio-behavioural one It is important to adopt a public health, human rights and people-centred approach when offering PrEP to those at substantial risk of HIV. Key messages for PrEP users and implementers Community awareness of the benefits and cautions about PrEP
- 26. Put the powerin the people, put the pill in theirs palms Sheena McCormack, July 24, 2017 26
Editor's Notes
- #4 HIV self-testing a process in which a person collects his or her own specimen (oral fluid or blood) and then performs a test and interprets the result, often in a private setting, either alone or with someone he or she trusts. HIV self-testing does not provide a definitive diagnosis. All reactive test results need further testing by health provider according to a national validated algorithm.
- #8 Evidence Map As of 25 October – 185 studies catalogued and counting….updated routinely.
- #11 but some concern about potential lack of counselling and support, accuracy of test results, and related costs Individuals surveyed about HIVST had concerns about possible harm, but most had not self-tested, and concerns were not founded in evidence –despite concern most still found HIVST acceptable
- #19 1. We know that the treat-all approach is where we should be going: ART access will prevent mortality, morbidity and HIV transmission 2. Continuing expansion of treatment is critical for all countries 3. But, treatment scale-up has ‘masked stagnation in the estimated annual number of new HIV infections’
- #20 What needs to be done to make PrEP as successful as possible?
- #25 Ref: 2014 UNAIDS GAP Report. Also note that harm reduction approaches for PWID impact parenteral risk, not sexual risk.