A Structural HIV Prevention Intervention Targeting High-risk Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sex Work
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Enrollment
- 385
- Locations
- 1
- Primary Endpoint
- Change in HIV/STI cumulative incidence over time
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in HIV/STI cumulative incidence over time
Time Frame: Baseline, 6 month, 12 month, 18 month, 24 month visits.
Participants will be tested for HIV, chlamydia and gonorrhea at each study visit.
Secondary Outcomes
- Sexual Risk Behaviors(Baseline, 6 month, 12 month, 18 month visits.)
- Illicit Drug Use(Baseline, 6 month, 12 month, 18 month visits.)