TRIM: Testing a Barbershop-based HIV Prevention Initiative Among Men
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Barbershops Group Participants recruited from intervention barbershops will receive the barbershop-based HIV prevention initiative. The trained barber will provide the following services during regular haircut services: general, status-neutral HIV education, HIV self-test kits, and information about where to receive HIV prevention services. The barber will also lead peer support group education every two months for clients enrolled in the study. |
Behavioral: General, status-neutral HIV education
General, status-neutral HIV education
Diagnostic Test: HIV self-test kits
HIV self-test kits
Other: Information about where to receive HIV prevention services
Information about where to receive HIV prevention services
Behavioral: Barber-led peer support group education
Barber-led peer support group education
|
| Active Comparator: Control Barbershops Group Participants recruited from control barbershops will receive standard-of-care HIV prevention services which include facility-based HIV risk reduction counseling and testing and providing information about facility distributed HIV self-test kits. |
Behavioral: Facility-based HIV risk reduction counseling
Facility-based HIV risk reduction counseling
Diagnostic Test: Facility-based HIV testing
Facility-based HIV testing
Other: Information about facility distributed HIV self-test kits
Information about facility distributed HIV self-test kits
Diagnostic Test: STI testing
STI testing
|
Outcome Measures
Primary Outcome Measures
- 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
- To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative [Week 13, Week 26, Week 39, Week 52, Week 65]
Consistent with this primary study objective, the following endpoint will be assessed from participants in the intervention group: Barber responses from surveys about feasibility and acceptability of intervention
- 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: Recruitment rates during enrollment and retention in study and barbershop activities at Week 26 and Week 52
- To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative [Week 13, Week 26, Week 39, Week 52, Week 65]
Consistent with this primary study objective, the following endpoint will be assessed from participants in the intervention group: Frequency of barber-participant interactions
- To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative [Week 13, Week 26, Week 39, Week 52, Week 65]
Consistent with this primary study objective, the following endpoint will be assessed from participants in the intervention group: Proportion of barber-participant interactions that include delivery of the intervention
Secondary Outcome Measures
- 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 between enrollment and study visit at Week 26, and between the Week 26 and Week 52 study visits
- 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 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 number of total sexual partners
- 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 number of new sexual partners
- 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 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: Self-reported referral to PEP care or use of PEP
- 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: Self-reported referral to PrEP care or use of any PrEP method during the study
Eligibility Criteria
Criteria
Inclusion Criteria:
Persons who identify as a heterosexual male and meet all of the following criteria are eligible for inclusion in this study:
- Age ≥ 16 years
- 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
-
Able and willing to provide informed consent
-
Behaviorally vulnerable to HIV, based on self-report of at least one of the following in the last three months:
-
Had condomless sex with a person of unknown HIV status or a person living with HIV
-
Had more than one sexual partner
-
HIV negative per Ugandan Ministry of Health guidelines and the Study-specific Procedures (SSP) Manual
-
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:
-
Not planning to stay in the study catchment area in the next 12 months
-
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- HIV Prevention Trials Network
- Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
- Study Chair: Zubair Lukyamuzi, MBChB, MPH, Makerere University, Johns Hopkins University Collaboration (MU-JHU)
- Study Chair: Brenda Gati Mirembe, MBChB, MscEpi, Makerere University, Johns Hopkins University Collaboration (MU-JHU)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HPTN 111
- UM1AI068619-17