Testing a Barbershop-based HIV Prevention Initiative Among Men

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: General, status-neutral HIV education
* Diagnostic Test: HIV self-test kits
* Other: Information about where to receive HIV prevention services
* Behavioral: Barber-led peer support group education
* Behavioral: Facility-based HIV risk reduction counseling
* Diagnostic Test: Facility-based HIV testing
* Other: Information about facility distributed HIV self-test kits
* Diagnostic Test: STI testing


Participation Criteria
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Eligibility Criteria
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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 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 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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Barbershops Group<br>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<br>* General, status-neutral HIV education<br>Diagnostic Test: HIV self-test kits<br>* HIV self-test kits<br>Other: Information about where to receive HIV prevention services<br>* Information about where to receive HIV prevention services<br>Behavioral: Barber-led peer support group education<br>* Barber-led peer support group education<br>|
| Active Comparator: Control Barbershops Group<br>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<br>* Facility-based HIV risk reduction counseling<br>Diagnostic Test: Facility-based HIV testing<br>* Facility-based HIV testing<br>Other: Information about facility distributed HIV self-test kits<br>* Information about facility distributed HIV self-test kits<br>Diagnostic Test: STI testing<br>* STI testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative | 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 | Week 26 and Week 52 | 
| To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative | 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 | Week 13, Week 26, Week 39, Week 52, Week 65 | 
| To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative | 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 | Week 26 and Week 52 | 
| To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative | Consistent with this primary study objective, the following endpoint will be assessed from participants in the intervention group: Frequency of barber-participant interactions | Week 13, Week 26, Week 39, Week 52, Week 65 | 
| To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative | 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 | Week 13, Week 26, Week 39, Week 52, Week 65 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare completion of self-initiated HIV testing between intervention and control groups | 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 | Week 26 and Week 52 | 
| To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition | 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 | Week 26 and Week 52 | 
| To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition | 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 | Week 26 and Week 52 | 
| To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition | 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 | Week 26 and Week 52 | 
| To compare interest in or use of HIV prevention services between intervention and control groups | Consistent with this secondary study objective, the following endpoint will be assessed: Voluntary medical male circumcision (VMMC) during the study | Week 26 and Week 52 | 
| To compare interest in or use of HIV prevention services between intervention and control groups | Consistent with this secondary study objective, the following endpoint will be assessed: Self-reported referral to PEP care or use of PEP | Week 26 and Week 52 | 
| To compare interest in or use of HIV prevention services between intervention and control groups | 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 | Week 26 and Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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