HOME Study: Evaluation of a Combination Support Package to Increase Uptake of Pre-exposure Prophylaxis and HIV/STI Testing Among Young Black and Latino MSM in the San Francisco Bay Area.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Efficacy of the HOME package to support linkage to PrEP or HIV care
研究概览
简要总结
Home HIV self-testing has been FDA approved and allows users to read their own HIV test results at home, while home sexually transmitted infection (STI) test self-collection allows men to use a swab at home and mail it in for testing. The purpose of this study is to learn how Men who have Sex with Men (MSM) use these new testing options, a set of online support tools, and the option to test with someone to support them (a testing "buddy").
We will also evaluate whether the online tools help these men to connect with HIV prevention services such as Pre-Exposure Prophylaxis (PrEP) if they test HIV negative, and to HIV care services if they test HIV positive.
详细描述
Participants will be randomized 2:1 after enrollment to the intervention and control condition. Data obtained from this study will be used to inform the further tailoring and distribution of an intervention for young Black and Latino MSM to increase utilization of home HIV self-testing and linkage to HIV treatment and Pre-Exposure Prophylaxis (PrEP).
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
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Self-identify as Black or Latino.
- •Report anal sex with at least one male sex partner in the prior 12 months.
- •HIV negative by self-report.
- •Currently own a cell phone.
- •Willing and able to provide written informed consent.
排除标准
- •Inadequate contact information for follow-up.
- •In a mutually monogamous sexual relationship for the past 12 months.
- •Currently taking PrEP.
- •Does not have reliable access to the Internet.
- •Does not live, work, or play in the San Francisco Bay Area.
- •Planning to move out of the Bay Area during the 9 month study period.
- •Previously participated in the HOME Pilot study.
- •Any medical, psychiatric, or social condition, or occupational, or other responsibility that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
结局指标
主要结局
Efficacy of the HOME package to support linkage to PrEP or HIV care
时间窗: 9 months
Between-arm differences in initiation of PrEP; qualitative evaluation of linkage to HIV care.
Efficacy of the HOME package to increase HIV and STI testing frequency.
时间窗: 9 months
The proportion of participants reporting HIV and STI testing rates between visits.
次要结局
- Feasibility of the individual components of the study intervention.(9 months)
- Acceptability of the HOME package to support linkage to HIV care or PrEP.(9 months)
研究者
Susan Buchbinder
Director, Bridge HIV
Public Health Foundation Enterprises, Inc.