Secondary distribution of HIV self-testing by FSW, pre-exposure prophylaxis (PrEP) starter packs and brief counseling to promote PrEP initiation and persistence among high-risk men in Uganda

PROJECT SUMMARY/ABSTRACT Current estimates project that roughly one in six new HIV infections in East and Southern Africa, where the majority of all incident HIV infections occur, are among key populations; including sex workers and their partners among others. In Uganda, HIV prevalence among female sex workers (FSWs) is about 35%. Male clients of

FSWs are a high-risk group for HIV infection, yet are unware of their HIV status and are a hidden population. Secondary distribution of HIV self-testing (HIVST) kits by women (including FSW) to their male partners has shown to be a promising strategy for increasing male testing including couple testing, HIV disclosure status and

safer sexual behaviors. In addition, WHO recently recognized HIVST as an “important tool” to generate demand for PrEP for populations with low access to health facilities such as male clients of FSW. However, there is little evidence on how HIVST affects PrEP uptake, adherence and persistence, particularly among male clients of

FSWs We propose to develop and pilot test an intervention (Kayungirizi) which will involve secondary distribution of HIVST by FSW to their male clients as an entry point to generate demand for PrEP, followed by an FSW-led intervention to address ongoing structural, interpersonal, and individual-level barriers (convenience,

confidentiality/stigma, flexibility) to promote PrEP initiation, adherence, and persistence among male clients of FSWs in Kampala, Uganda. Our aims are to; i) Create the proposed Kayungirizi (“to connect”) intervention to promote PrEP initiation and persistence among male clients of FSW through qualitative research informing

adaptation and integration of components of local models and evidence-based care engagement interventions. We will conduct qualitative research with male clients, FSW, and other stakeholders to elicit their feedback on the intervention and understand their perceptions of the barriers and facilitators for PrEP initiation and

persistence, and preferences and barriers regarding oral vs long-acting injectable PrEP. ii) Conduct an initial (stage 1a) small pilot of the intervention and refine it in preparation for the stage 1b pilot trial. iii) Determine acceptability, feasibility, and safety of the intervention and preliminary estimates of the potential for the

intervention, compared to the control, to promote PrEP initiation, adherence, and persistence among male clients of FSW (stage 1b). We will randomize geographic areas to the intervention or a control consisting of vouchers for free HIVST pick-up from a clinic and referrals for PrEP and enroll 140 male clients (70 per arm) across

clusters. We will assess outcomes at baseline, 3-, and 6-month follow-up. Study findings will be used to guide a subsequent R01 proposal to test the intervention in a larger clinical trial.