A Structural HIV Prevention Intervention Targeting High-risk Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 2
- 主要终点
- Change in HIV/STI cumulative incidence over time
研究概览
简要总结
The purpose of this study is to assess the effectiveness of a community based combination HIV prevention package, including biomedical, behavioral, and structural services for female sex workers (FSW) in Baltimore, Maryland. This study is a prospective two-group trial comparing the efficacy of a community-based comprehensive HIV/STI prevention package compared to standard of care (HIV testing, counseling, and referrals) among FSWs. Outcomes will be assessed through self-reported illicit drug use and sexual risk behaviors (behavioral) as well as HIV/STI testing (biological).
详细描述
This study aims:
- To examine the effect of exposure to community intervention components on HIV/STI risk behaviors (e.g., drug use/unprotected sex), and HIV/STI cumulative incidence over time in FSWs in the intervention (n=275) compared to those in the comparison group (N=175);
a. to explore the intervention's effects on the risk environment of exotic dance clubs (N=15) over time 2. To examine how socio-structural (e.g., social cohesion, stigma) and structural vulnerability (e.g., financial and housing stability) indicators change and are associated with the biological and behavioral outcomes over time in FSWs in the intervention (n=275) compared to those in the comparison (n=175) group
a. examine the role of these indicators as mediators of the intervention effect on study outcomes; 3. To examine the intervention's implementation through qualitative (e.g., in-depth interviews) and quantitative (e.g., assessment of program fit, reach, facilitators, barriers, program costs) measures.
3.1 To examine participant knowledge of the COVID-19 crisis as well as the impact of the crisis on their mental, and physical well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older;
- •Assigned female at birth and identify with female gender
- •Have exchanged sex in Baltimore City at least 3 times in the past 3 months;
- •Willing to undergo testing for HIV, gonorrhea, and chlamydia
- •Willing to provide locator information.
排除标准
- •Inability to provide informed consent in English;
- •Women who are determined as too high or drunk;
- •Women who are cognitively impaired.
- •Currently enrolled in the SAPPHIRE study
结局指标
主要结局
Change in HIV/STI cumulative incidence over time
时间窗: Baseline, 6 month, 12 month, 18 month, 24 month visits.
Participants will be tested for HIV, chlamydia and gonorrhea at each study visit.
次要结局
- Sexual Risk Behaviors(Baseline, 6 month, 12 month, 18 month visits.)
- Illicit Drug Use(Baseline, 6 month, 12 month, 18 month visits.)