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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
250
General, status-neutral HIV education
HIV self-test kits
Information about where to receive HIV prevention services
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
Kampala, Uganda
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 13, Week 26, Week 39, Week 52, Week 65
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Barber-led peer support group education
Facility-based HIV risk reduction counseling
Facility-based HIV testing
Information about facility distributed HIV self-test kits
STI testing
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 52