Integrating secondary distribution of HIV self-testing and enhanced service linkage to promote PrEP uptake and persistence among high-risk men

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 high-risk groups; including women at high-risk of HIV and their partners. In Uganda, HIV prevalence among women at highest risk is about 35%. The male partners of such women are a high-risk group for HIV infection, yet are unware of their HIV status. Secondary distribution of HIV self-testing (HIVST) kits by women to their male partners has shown to be a promising strategy for increasing male testing including couple testing, and HIV disclosure status.

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 men. However, there is little evidence on how HIVST affects PrEP uptake, adherence and persistence, particularly among men. We propose to develop and pilot test an intervention which will involve secondary distribution of HIVST by women to their partners as an entry point to generate demand for PrEP, followed by an intervention to address ongoing structural, interpersonal, and individual-level barriers (convenience, confidentiality, flexibility) to promote PrEP initiation, adherence, and persistence among males in Kampala, Uganda. Our aims are to; i) Create the proposed intervention to promote PrEP initiation and persistence among male partners of women at high-risk for HIV through qualitative research informing adaptation and integration of components of local models and evidence-based care engagement interventions.

We will conduct qualitative research with key 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 (stage 1b). We will randomize geographic areas to the intervention or a control and enroll 140 males (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.

Grant Number: 1R34MH132479-01A1
NIH Institute/Center: NIH
Principal Investigator: ESTHER BUREGYEYA