Feasibility and Acceptability of Barbershop-Based HIV Prevention Among Heterosexual Men in Kalangala Islands, Uganda: Protocol for a Cluster Randomized Trial (HPTN 111)

BACKGROUND: Globally, successful strategies to engage high-risk heterosexual men in HIV prevention are scarce, resulting in limited access and uptake. Barbershops offer a potential venue for HIV prevention. OBJECTIVE: The primary objective was to evaluate the feasibility and acceptability of a barbershop-based HIV prevention initiative. The secondary objectives were to compare completion of self-initiated HIV testing between intervention and control groups, evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition, compare interest in or use of HIV prevention services between intervention and control groups, and assess interest in long-acting preexposure prophylaxis among all participants and by study arm. The exploratory objective was to evaluate the preliminary effectiveness of the intervention on incident sexually transmitted infections. METHODS: HIV Prevention Trials Network 111 (HPTN 111; Testing a Barbershop-based HIV Prevention Initiative Among Men [TRIM]) is a cluster randomized trial conducted in Kalangala district, Uganda, among barbershop-going men. Approximately 250 men were assigned to either an intervention barbershop (n=12) or a control barbershop to receive the standard of care (n=6). Participants assigned to intervention barbershops received an intervention package that included HIV-status neutral education, distribution of HIV self-test kits, and barber-led peer group sessions. Feasibility and acceptability of the intervention were assessed from participants in the intervention group at week 26 and week 52. The study will also assess the effectiveness of the intervention on changes in HIV testing and use of prevention services. Self-reported sexual behaviors associated with HIV incidence and sexually transmitted infection incidence rates will also be compared to the standard of care. RESULTS: Data collection began in March 2024 and concluded in June 2025. Participants were followed for 12 months. Data analysis has been completed. The primary manuscript is expected to be submitted for publication by March 30, 2026. CONCLUSIONS: The results of this study will provide crucial information about the feasibility and acceptability of novel interventions, such as barbershops, to impact behavior change, as well as about the engagement of heterosexual men in high HIV transmission settings in HIV prevention and treatment trials in the future. TRIAL REGISTRATION: ClinicalTrials.gov NCT06148584; https://clinicaltrials.gov/study/NCT06148584. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/87612.