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临床试验/NCT04413591
NCT04413591
已完成
不适用

A Structural HIV Prevention Intervention Targeting High-risk Women

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 385 人2017年9月14日
适应症Sex Work

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Sex Work
发起方
Johns Hopkins Bloomberg School of Public Health
入组人数
385
试验地点
1
主要终点
Change in HIV/STI cumulative incidence over time
状态
已完成
最后更新
3年前

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: 1. 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.

注册库
clinicaltrials.gov
开始日期
2017年9月14日
结束日期
2020年9月22日
最后更新
3年前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

入排标准

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.)

研究点 (1)

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