Acceptability, Feasibility, and Safety of the Shauriana Intervention for Young Kenyan Gay, Bisexual, and Other Men who Have Sex with Men, and Exploration of Potential Impact on Sexual Health Outcomes.

In rights-constrained settings with pervasive stigma, a holistic approach to HIV prevention is needed to ensure knowledge and use of different HIV prevention tools and promote both sexual and mental health. In close collaboration with GBMSM community leaders in Kisumu, we developed a theory-based, culturally-tailored HIV prevention intervention that integrates sexual health and mental health support for young Kenyan GBMSM. We conducted a randomized trial with 6 months of follow-up to assess acceptability, feasibility, and safety of the intervention and explore its potential impact on secondary outcomes, compared to standard care. Among 60 participants, median age was 25 years (inter-quartile range 22-28). Retention at month 6 was 93.1% (27 of 29) in the intervention arm and 87.1% (27 of 31) in standard care. Acceptability was high, with most participants rating each session's value and relevance at 1 ("strongly agree"). Intervention delivery was feasible and attendance was excellent, with 29 (100%) intervention participants completing all five sessions and 18 (62.1%) attending an optional session to consolidate learning. No social harms occurred. Exploratory analyses suggest improved PrEP knowledge and improved knowledge about healthy relationships and communication, as well as higher condom use at last sex. The intervention was found to be acceptable, feasible and safe in this small study. Future work is warranted to evaluate this intervention in a larger trial, given the need for person-centered, holistic interventions supporting sexual health, mental well-being, and the full range of HIV prevention tools available.Clinical trial registration: NCT04550221, registered on 9/8/2020.