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| ID | Type | Description | Link |
|---|---|---|---|
| UM1AI068619-17 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Barbershops Group | Experimental | 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. |
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| Control Barbershops Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General, status-neutral HIV education | Behavioral | General, status-neutral HIV education |
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| 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 |
| 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 during the study follow-up | Week 26 and Week 52 |
| To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition |
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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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MU-JHU Research Collaboration (MUJHU CARE LTD) CRS | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41996694 | Derived | Scoville C, Gati Mirembe B, Voldal E, Maena J, Etima J, Harris-Wisecarver J, Rukundo I, Ssemere H, Kemigisha D, Nakyanzi T, Nakalega R, Conserve DF, Albano M, Dyer M, Piwowar-Manning E, Spiegel H, Nakabiito C, Mujugira A, Donnell D, Lukyamuzi Z. Feasibility and Acceptability of Barbershop-Based HIV Prevention Among Heterosexual Men in Kalangala Islands, Uganda: Protocol for a Cluster Randomized Trial (HPTN 111). JMIR Res Protoc. 2026 Apr 17;15:e87612. doi: 10.2196/87612. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 13, 2020 |
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| HIV self-test kits | Diagnostic Test | HIV self-test kits |
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| Information about where to receive HIV prevention services | Other | Information about where to receive HIV prevention services |
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| Barber-led peer support group education | Behavioral | Barber-led peer support group education |
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| Facility-based HIV risk reduction counseling | Behavioral | Facility-based HIV risk reduction counseling |
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| Facility-based HIV testing | Diagnostic Test | Facility-based HIV testing |
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| Information about facility distributed HIV self-test kits | Other | Information about facility distributed HIV self-test kits |
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| STI testing | Diagnostic Test | STI testing |
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| Week 13, Week 26, Week 39, Week 52, Week 65 |
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 access 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 access to PrEP care or use of any PrEP method during the study | Week 26 and Week 52 |
| To assess the preliminary interest in Long-Acting PrEP (LAPrEP) among all participants | Consistent with this secondary study objective, the following endpoints will be assessed: Self-reported interest in LAPrEP at Week 52 | Week 52 |
| Jul 8, 2025 |
| Prot_SAP_ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 24, 2026 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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