Newly diagnosed HIV-positive men who have sex with men (MSM) living in South Africa, a high prevalence population characterized with poor linkage to and engagement in HIV care, face significant barriers to clinical care. Peer navigators could potentially improve the clinical outcomes for these men. This study aims to adapt a peer navigation intervention; to conduct pilot randomized trial of the intervention; to assess the acceptability and feasibility of the peer navigation intervention; and to incorporate the findings into a full-scale, multi-site efficacy trial.
HIV-positive men who have sex with men (MSM) in South Africa are not optimally engaged in HIV care. In MSM communities in rural Ehlanzeni district of Mpumalanga province, where prevalence is estimated at 23% and incidence at nearly 30 per 100 person-years, less than 10% of HIV-positive MSM are engaged in care or taking ART. Closing the substantial gap between treatment need and uptake among MSM is critical as South Africa implements 2015 guidelines recommending ART at CD4<500. Targeted intervention approaches to improve HIV-positive MSM's engagement in care are urgently needed, yet there are presently no interventions of proven efficacy that can be taken to scale. Patient navigation strategies, particularly peer navigation (PN), have been implemented in multiple contexts and tailored to multiple populations, and show promise in improving HIV continuum of care outcomes, including engagement, retention, ART adherence, and viral suppression. To address the urgent need for such an intervention for South African MSM, we propose research to adapt, manualize, and implement a PN intervention model for South African MSM (Aim 1), to assess the feasibility and acceptability of the PN intervention with 100 HIV-positive MSM in Ehlanzeni district (Aim 2), and to prepare for a future full-scale, multi-site efficacy trial of the PN intervention by comparing continuum of care outcomes of those 100 MSM to 50 HIV-positive MSM receiving standard referrals to clinical care (Aim 3). We will achieve these aims in two phases:
1) systematic, qualitative intervention adaptation research, and
2) a pilot randomized controlled trial of MSM randomly assigned to PN or standard-of-care conditions.
We will leverage findings and infrastructure developed during the NIAID-sponsored Mpumalanga Men's Study (R01AI089292, Lane), an NIMH-sponsored HIV Self-Testing Study (R21MH103038, Lippman), and a PEPFAR-sponsored trial of peer navigation among general population clients (Current Controlled Trials NCT02417233) to carry out the proposed research. We hypothesize that the PN intervention will be feasible and acceptable to HIV-positive MSM; that those randomized to PN will show greater improvements in engagement, retention, adherence, and viral suppression compared to those in the standard-of-care; and that a feasible and acceptable PN intervention may be combined with other prevention approaches that will ultimately show the community-level effects across the continuum-of-care indicators necessary to reduce incidence in this high-burden key population.