JMIR Publications

ABSTRACT

Background:

Men, especially heterosexual men, have continued to lag in the global HIV response, imperiling their health but also sustaining HIV transmission. In Africa, the HIV epidemic is largely transmitted through heterosexual and heterosexual men are significantly affected, as they are less likely than women to know their HIV status or engage in HIV prevention and care services. Uganda is one of the country’s most affected by HIV, with the epidemic being more prevalent in the fishing communities, which are predominantly inhabited by men. Studies have shown that men prefer community-based HIV services as opposed to facility-based services. Therefore, there is a need for evidence-based, community-tailored male interventions to enhance men’s engagement in HIV services, hence the conduct of the HPTN 111 (TRIM) study.

Objective:

The primary objective of this study is to evaluate feasibility, acceptability, and preliminary effectiveness of a barbershop-based HIV prevention initiative among heterosexual men with risk factors for HIV acquisition in a high-prevalence setting in Uganda.

Methods:

HPTN 111 (TRIM) is a cluster randomized study where 18 barbershops in the Kalangala district, Uganda, will be purposively selected and randomized 2:1 to a barbershop-based HIV prevention initiative (intervention) or standard-of-care (control). All barbershops will recruit their male customers in the study. Participants enrolled at the intervention barbershops will receive a multicomponent intervention including barber-led status neutral HIV education and referral to HIV prevention services, distribution of HIV self-test kits through barbershops, and barber-led peer group discussions. Participants enrolled from the control barbershops will receive standard-of-care HIV prevention services from local health facilities. All participants will be followed for 12 months to assess the feasibility and acceptability of the intervention and its preliminary effectiveness in improving uptake of HIV testing, reduction in behaviors associated with HIV acquisition, use of HIV prevention services, and reduction in the incidence of sexually transmitted infections.

Results:

As of 30th June 2025, the study was completed. Primary data analysis is ongoing and expected to be completed by 31 Dec 2025. Following completion of primary analysis, the initial manuscript will be submitted for publication by 30th Mar 2026.

Conclusions:

This study responds to the urgent need to develop HIV prevention interventions for heterosexual men using accessible, scalable, and affordable initiatives. Therefore, this study highlights the potential role of barbershop-based initiatives in advancing HIV prevention services. If found feasible and acceptable, the study will inform modifications and guide testing of this approach in a larger trial. Clinical Trial: ClinicalTrials.gov, NCT06148584, registered 11/28/2023 (V1.0), Study Details | Testing a Barbershop-based HIV Prevention Initiative Among Men | ClinicalTrials.gov