Community Administered PrEP for Young Men in Rural South Africa

Eradicating HIV by 2030 will be impossible without successfully engaging young men in HIV prevention and treatment. Young men, an important HIV reservoir, are challenging to engage in HIV services and suffer from worse outcomes at every step of the HIV cascade, including HIV prevention. In South Africa, PrEP is being rolled out through primary care clinics, where men feel unwelcome and stigmatized, supporting the need for differentiated service delivery models to facilitate PrEP implementation among men. Evidence for community-based delivery models, well-established for HIV testing and antiretroviral therapy, are now needed for PrEP.  The investigators have demonstrated the feasibility and acceptability of a Community-Administered PrEP (CAP) delivery model tailored to rural resource-limited settings. Community recruitment of young men for HIV services has been successful at shebeens, venues for alcohol consumption, which are primary settings for social mixing, identification of sexual partners, and high HIV risk behaviours, but may also serve as opportunities to target young men for HIV prevention. To provide evidence-based models of differentiated care targeting young men, the investigators propose a cluster randomized trial to evaluate the effectiveness of Community Administered PrEP compared to an enhanced standard of care, defined as PrEP initiation through existing clinic-based pathways. Young men will be recruited from community shebeens. A WHO-endorsed, locally validated alcohol intervention is incorporated using a factorial design. The primary outcome will be retention on PrEP at 12 months, and secondary outcomes include PrEP uptake and adherence (Aim 1). We will (Aim 2) perform a convergent mixed methods study to ascertain the impact of alcohol misuse and the alcohol intervention on PrEP outcomes. Moderation analyses will be performed to assess whether the alcohol intervention influences the effectiveness of Community Administered PrEP. Independent of whether CAP is found to be favorable, we will conduct mathematical modelling (Aim 3) to identify thresholds for population level impact and cost-effectiveness of CAP and other community-based models for engaging men in PrEP services.  This outstanding multidisciplinary US and South African team has the capacity and experience to successfully conduct this proposal. The findings from this trial will inform PrEP implementation throughout sub-Saharan Africa and globally.