BOMA HOTEL, NAIROBI, KENYA HIV SELF TESTING IN SA BOMA HOTEL, NAIROBI, KENYA DR THATO CHIDARIKIRE 27 March 2017

CURRENT SITUATION

Where is South Africa with 90 90 90?

National HIV Care and Treatment Cascade

Current approach to first 90 HTS Policy revised in 2016 – embraces full range of services Task sharing/shifting: Lay counselors trained to conduct HTS using RDT – 2010 (more efficient use of resources) Quality HTS and Delivery of Correct Results Validation of national algorithms HTS – full range of services: 5Cs and Consent, Confidentiality (not secrecy), Counselling: Pre-test information & appropriate post-test counselling, Correct diagnosis (QA), Connection: Linkage to prevention, treatment and care services. Task shifting_ Use of lay counsellors

Current approach to first 90 (cont) Ongoing training, mentoring and support for QA Introduced use of data to maximise “yield” – learn to re-prioritize testing Testing modalities: HTS Facility based (CICT; strategic use of PICT) Community based (Stand alone, mobile, work-place, higher institutions, home based)

HIVST – potential benefits Potential impact on 1st ‘90’ by increasing access and acceptability for under-tested & at-risk populations that need frequent or routine testing (SD couples, men, adolescents, FSW, MSM). Can reach untested and test-averse populations. Potential approach to scale-up HTS and accelerate case detection Contribute to closing testing gap in South Africa Particularly for men, young women, female sex workers, MSM

Target product profile High quality manufacturing standards Must be appropriate for an untrained, non-professional layperson Acceptable analytical performance in laboratory settings. High clinical sensitivity/specificity with untrained users Pictorial instructions for use with any text-based instruction translated into local languages

Target product profile Fewer test steps with simple sample transfer Simple to interpret test results Fast time to result Test results to remain stable for a longer period Product to include referrals for assistance with results and linkage to care

HIVST delivery models This will depend on the target population: PHC facilities, Hospitals and pharmacies Workplace programmes (mines, farms, construction, mostly to reach men) Special services (ANC, STI clinics, FP, VMMC, PrEP) (for both directly assisted and unassisted HIVST)

Current Policy Environment for HIVST

International: WHO Guidance

National Guidance for HIVST in SA SA HIV Self-Testing Policy Guideline consideration - DRAFT

National Guidance for HIVST in SA cont SA HTS Policy recommends HIVST as expansion to testing. HIVST as screening test and not diagnostic test Guidelines for implementation are still in draft form in collaboration with the SA Clinician Society

Addressing policy and regulatory barriers: registering RDTs, enabling non-health care workers to offer testing

Addressing regulatory need 2015: SA Pharmacy Council approved selling of HIV self testing kits by pharmacies: Recommends QA 2016: Published a notice regarding minimum standards for selling of the kits On-going demonstration projects to inform implementation: cover feasibility, acceptability, useability, targetting, distribution, waste disposal etc NDOH working with Wits RHI, WHO and the SA Clinician Society to finalise the implementation guidelines Working with NICD for quality recommendations in laboratoories Rollout in Public Sector will be informed by WHO Pre-qualification Different types of HIV Self test kits are already available in the market (private sector) and need to be regulated and guided.

Addressing regulatory need cont HIVST in South Africa has been presented by many as ethical, acceptable and potentially revolutionary if done properly, but… Engaging the South African Health Products Regulatory Authority (SAHPRA) is critical to regulating & enabling HIVST Regulation will allow for identification of quality-assured HIVST kits & requirements, e.g. importance of confirming a reactive self-test

Lack of regulation leads to…..

Evidence and Demonstration projects for HIVST

Questions which informed studies on HIVST in SA Who should have access? All populations or priority groups? Adolescents and young people? Age of consent? How & where will it be implemented & distributed? Distribution models Cost? Will it be free or subsidized to users?

Findings so far… High accuracy of community-based “assisted” HIVST using oral fluid RDT: High agreement w/ HTS by HWs (99.8% (Kappa 0.9925)) Very few invalid results High sensitivity (98.7%) & specificity (100%) Qualitative study found HIVST highly acceptable & might help people in informal settlements access HTS; esp men & youth

Findings so far cont… Ndlovu Health (Limpopo) HSTAR (Gauteng) High usability, concordance, Sens and Spec in rural population HSTAR (Gauteng) High usability in Oral Fluid and Finger stick products in Inner City Johannesburg iTEACH (Gauteng, Mpumalanga, KZN) High concordance, but low LTC in Truck Drivers UCT (Western Cape) High acceptability in MSM, and demonstrated utility of online platforms for sale and distribution Anova (North West) High acceptability in MSM

Wits RHI HSTAR Programme Programme is conducting usability and assessments to fast-track HIVST HIV Self-Testing RDT Evaluation Non Clinical studies Usability Assessment LEVEL 1 Trained User Assessment LEVEL 2 Intended Use Assessment LEVEL 3: Expected Use Assessment LEVEL 4 The HSTAR Programme, currently funded by the BMGF and AIDS Fonds, is evaluating HIV self-testing in the South African market, actively engaging with policy makers and communities, to pave the way for several well-tested products to enter the market, and facilitate the process towards World Health Organisation Pre-Qualification and National Guidance on ST. The programme address access, acceptability, product performance, implementation, assessment of social harms and linkage-to-care. The programme has a multi-phased approach for the performance evaluation of potential devices: Phase 1: Usability Assessments of prospective HIV Self-Testing devices including Instruction for Use comprehension and result interpretation. Phase 2: Evaluation of prospective HIVST devices in the hands of Trained Users. Phase 3: Evaluation of prospective HIVST devices in the hands of untrained users from the general population

HIVST & Young people Evaluating community-based “assisted” HIVST among young people in Cape Town Report high uptake among first time testers, high acceptability & preference for HIVST compared to standard HTS Source: Bekker et al AIDS 2016

Phase – II of PSI/UNITAID STAR Project Largest project on HIVST – 2 Phase – II of PSI/UNITAID STAR Project Largest project on HIVST – 2.4 million tests Project underway in Malawi, Zambia and Zimbabwe – South Africa to participate following Phase-I The project will be critical to identifying the most ethical, acceptable, effective and sustainable HIVST approaches for South Africa So what’s next –WHO and partners part of the UNITAID STAR project will be starting the largest study on HIV self-testing very soon. This project will be conducting implementation science that will fill in knowledge gaps, inform guideline development and policy change and shape the market so that low cost products can become widely available. But while I am highlighting this I also want to give a shout out the expert level meeting we had yesterday where we heard a lot of positive and promising results. All this work and collaborating together will be critical for WHO guidance and filling knowledge gaps. Source: WHO, 2015 http://www.who.int/hiv/mediacentre/news/unitaid_hiv-self-testing/en/

What’s next?

Way forward/Conclusion Facilitate finalisation of minimum standards to regulate currently available HIVS test kits Finalisation of the implementation Guidelines on HIVST Finalisation of the demo projects to provide critical data to guide implementation Awaiting WHO PQ Target implementation in specific geographic areas, populations and settings

Acknowledgements Thank you to everyone who was involved! WHO WITS RHI NDOH Contact: Thato.Chidarikire@health.gov.za Alt: matshabathato44@gmail.com