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VARG Statement on PrEP in HIV Prevention Trials, Nov 2017

As of November 2017, seven HIV prevention efficacy trials are underway or imminent across the globe – enrolling nearly 25,000 individuals at risk of HIV. South and Southern Africa are leading the way, and will enroll nearly 13,000 sexually active women and men in five of these trials. Meanwhile, the HIV prevention field continues to expand, most notably as daily oral PrEP is approved and national programs roll out, including in many of these trial countries across Southern Africa.

Over the week of 30 October in Cape Town, advocates weighed in on discussions led by the South African Medical Research Council (SA MRC) about the standard of care provided to clinical trial participants. The SA MRC convened a regional summit on 2-3 Nov, bringing together researchers, regulatory authorities, policy makers, ethicists and advocates with the aim of building consensus on the standard of care – and how to provide it to participants – in trials across Southern Africa, with a focus particularly on the provision of oral PrEP in HIV prevention trials.

The summit was preceded by a two-day advocates’ “Imbizo” – a South African term typically used to describe a gathering led by a traditional leader to discuss policy issues. Jointly convened by the SA MRC and the Vaccine Advocacy Resource Group (VARG), over these two days, advocates from Kenya, Malawi, Nigeria, South Africa, Uganda and Zimbabwe discussed, debated, and formed their input to the summit.

It may seem simple: trial participants have the right to the highest standard of HIV prevention and care – as outlined in both the WHO and UNAIDS ethics guidance and the UNAIDS and AVAC Good Participatory Practice Guidelines. But the ethics and the detailed mechanisms of how prevention interventions are provided – especially oral PrEP in this stage – are complex. Opinions differ and politics abound. As both these guidelines highlights, advocates and civil society should have a voice in these decisions, and it is good to see this happening in Cape Town this week. It will also be essential to ensure this engagement in ongoing and meaningful in operationalizing how to act in real time on these issues.

While the meeting is just concluding and a formal summary will only be out in the weeks to come, Maureen Luba, Joint Advocacy Project Coordinator at CEDEP/MANET+, member of the VARG and past AVAC Advocacy Fellow, was on the agenda of the summit to present an advocates’ statement on the standard of care in trials. Stay tuned for more updates and next steps.

(Also, by way of background, on 26 October, AVAC hosted a webinar with colleagues from the Treatment Action Group (TAG), along with advocates, researchers and GPP practitioners, to discuss these issues and the recommendations from the TAG's recently released white paper, HIV Research in the Era of PrEP: The Implications of TDF/FTC for Biomedical Prevention Trials. Slides, webinar recording and links are here.)