Clinical trial NCT06148584: Testing a Barbershop-based HIV Prevention Initiative Among Men
Official title: Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative Among Heterosexual Men in Kalangala Islands, Uganda: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
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
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-11-28
Enrollment: 250
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative
timeFrame: Week 26 and Week 52
measure: To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative
timeFrame: Week 13, Week 26, Week 39, Week 52, Week 65
measure: To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative
timeFrame: Week 26 and Week 52
measure: To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative
timeFrame: Week 13, Week 26, Week 39, Week 52, Week 65
measure: To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative
timeFrame: Week 13, Week 26, Week 39, Week 52, Week 65
Secondary outcomes:
measure: To compare completion of self-initiated HIV testing between intervention and control groups
timeFrame: Week 26 and Week 52
measure: To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition
timeFrame: Week 26 and Week 52
measure: To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition
timeFrame: Week 26 and Week 52
measure: To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition
timeFrame: Week 26 and Week 52
measure: To compare interest in or use of HIV prevention services between intervention and control groups
timeFrame: Week 26 and Week 52
measure: To compare interest in or use of HIV prevention services between intervention and control groups
timeFrame: Week 26 and Week 52
measure: To compare interest in or use of HIV prevention services between intervention and control groups
timeFrame: Week 26 and Week 52
measure: To assess the preliminary interest in Long-Acting PrEP (LAPrEP) among all participants
timeFrame: Week 52
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
Study officials:
affiliation: Makerere University, Johns Hopkins University Collaboration (MU-JHU)
name: Zubair Lukyamuzi, MBChB, MPH
role: STUDY_CHAIR
affiliation: Makerere University, Johns Hopkins University Collaboration (MU-JHU)
name: Brenda Gati Mirembe, MBChB, MscEpi
role: STUDY_CHAIR
References: