A targeted HIV self-test secondary distribution intervention to engage high-risk men in Kenya: study protocol for the Pamoja cluster-randomized controlled trial (Preprint)

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Abstract
UNSTRUCTURED Background: In the study setting of western Kenya, as well as in sub-Saharan Africa more broadly, men are less likely to be engaged at each step of the HIV care cascade. Transactional sex constitutes a leading driver of HIV transmission between transactional and non-paying sexual partners, and men who purchase sex (MPS) represent a particularly high-risk and under-prioritized population. Data from South Africa estimates that sex between MPS and their non‐transactional female partners contributed 42% of all new HIV infections. Among women who sell sex (WSS) in Kisumu and Siaya Counties HIV prevalence is ~30%, and 65% of men report ever purchasing sex. This study seeks to identify and engage MPS in HIV services. Methods: This is a randomized stepped-wedge trial to evaluate whether the provision of multiple oral fluid-based HIV self-test kits to WSS to secondarily distribute to their male partners who purchase sex can promote HIV service uptake by male partners. The study will recruit 5,000 WSS in 25 clusters. Clusters will be randomized to the order in which they receive the intervention. Self-test kits will contain validated instructions for use and tailored information on clinics within the cluster, and empirically tested messaging on the benefits of ART for those who test positive and PrEP for those who test negative. The primary outcome will be the proportion of MPS who link to confirmatory testing in health facilities within study clusters during the intervention versus control periods. Secondary outcomes include the proportion of HIV case diagnoses, and ART or PrEP initiation among men. We will also analyze the cost-effectiveness of the intervention and conduct a process evaluation to assess mechanisms impacting intervention effectiveness, pathways for linkage among MPS, and support for men’s linkage to HIV services under a secondary distribution model. Discussion: Data generated from the study will provide evidence of the effectiveness of this HIVST secondary distribution intervention in identifying and engaging MPS in HIV testing, prevention and treatment services. If effective, this strategy can help in reaching men at elevated risk of HIV. Clinical trial registration: NCT05882916 (Reaching the Last 20% (the Pamoja Kwa Afya Study) | ClinicalTrials.gov). Date of registration: 26 May 2023.