Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative Among Heterosexual Men in Kalangala Islands, Uganda: A Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative
时间窗: 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
次要结局
- To compare completion of self-initiated HIV testing between intervention and control groups(Week 26 and Week 52)
- To assess the preliminary interest in Long-Acting PrEP (LAPrEP) among all participants(Week 52)
- To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition(Week 26 and Week 52)
- To compare interest in or use of HIV prevention services between intervention and control groups(Week 26 and Week 52)