HIV Infections
Conditions
Keywords
HIV, HIV Prevention, Barbershop, Uganda, Kalangala District, Heterosexual Men, HIV Education, HIV Self-test Kits, Peer Support, HIV Testing, HIV Risk Reduction Counseling, STI Testing
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALGeneral, status-neutral HIV education
General, status-neutral HIV education
DIAGNOSTIC_TESTHIV self-test kits
HIV self-test kits
OTHERInformation about where to receive HIV prevention services
Information about where to receive HIV prevention services
BEHAVIORALBarber-led peer support group education
Barber-led peer support group education
BEHAVIORALFacility-based HIV risk reduction counseling
Facility-based HIV risk reduction counseling
DIAGNOSTIC_TESTFacility-based HIV testing
Facility-based HIV testing
OTHERInformation about facility distributed HIV self-test kits
Information about facility distributed HIV self-test kits
DIAGNOSTIC_TESTSTI testing
STI testing
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Prevention Trials Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative | Week 26 and Week 52 | Consistent with this primary study objective, the following endpoint will be assessed from participants in the intervention group: Participant responses from surveys at Week 26 and Week 52 about acceptability of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare completion of self-initiated HIV testing between intervention and control groups | Week 26 and Week 52 | Consistent with this secondary study objective, the following endpoint will be assessed: Self-report of HIV test conducted during the study follow-up |
| To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition | Week 26 and Week 52 | Consistent with this secondary study objective, the following endpoint will be assessed: Self-reported risk behaviors at Week 26 and Week 52, including condom use |
| To compare interest in or use of HIV prevention services between intervention and control groups | Week 26 and Week 52 | Consistent with this secondary study objective, the following endpoint will be assessed: Voluntary medical male circumcision (VMMC) during the study |
| To assess the preliminary interest in Long-Acting PrEP (LAPrEP) among all participants | Week 52 | Consistent with this secondary study objective, the following endpoints will be assessed: Self-reported interest in LAPrEP at Week 52 |
Countries
Uganda
Outcome results
None listed