Testing a Barbershop-based HIV Prevention Initiative Among Men

Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative Among Heterosexual Men in Kalangala Islands, Uganda: A Cluster Randomized Trial

To test community-based approaches to engage heterosexual men at risk for HIV and specifically to assess the feasibility and acceptability of a barbershop based HIV prevention program.

HPTN 111/TRIM is a cluster randomized study to assess the feasibility and acceptability of a barbershop-based HIV prevention program. Eighteen barbershops in Kalangala District, Uganda will be purposively selected to participate in the study and randomized 2:1 to provide the barbershop-based HIV prevention initiative (intervention) or the standard-of-care (control). Individual participants will be enrolled from the barbershops and receive intervention or control services based on their barbershop. The barbershop-based HIV prevention initiative will include barber provided status-neutral HIV education, HIV self-test kits, and information about where to receive HIV prevention services.

Inclusion Criteria:

Persons who identify as a heterosexual male and meet all of the following criteria are eligible for inclusion in this study:

1. Age ≥ 16 years

   a. Any participants 16-17 years old will be enrolled following the Uganda National Council for Science and Technology (UNCST) guidelines for mature and emancipated minors

2. Able and willing to provide informed consent

3. Behaviorally vulnerable to HIV, based on self-report of at least one of the following in the last three months:

   1. Had condomless sex with a person of unknown HIV status or a person living with HIV
   2. Had more than one sexual partner

4. HIV negative per Ugandan Ministry of Health guidelines and the Study-specific Procedures (SSP) Manual

5. Is a regular customer at a participating barbershop as defined in the SSP Manual

Exclusion Criteria:

Persons who meet any of the following criteria will be excluded from this study:

1. Not planning to stay in the study catchment area in the next 12 months
2. Any other condition that in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Participants who report sex with other men will not be excluded from this study so long as they meet the inclusion and exclusion criteria listed above.