A Structural HIV Prevention Intervention Targeting High-risk Women

Study Overview
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Brief Summary
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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
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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 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; 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.

Official Title
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A Structural HIV Prevention Intervention Targeting High-risk Women

Conditions
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Sex Work

Intervention / Treatment
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* Behavioral: Community based combination HIV prevention package


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Area<br>Participants are assigned to the intervention area or the control area based on the location they were recruited in. | Behavioral: Community based combination HIV prevention package<br>* The intervention compares the efficacy of a community-based comprehensive HIV/STI prevention package compared to standard of care (HIV testing, counseling, and referrals) among Female Sex Workers.<br>|
| No Intervention: Control Area<br>Participants are assigned to the intervention area or the control area based on the location they were recruited in. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HIV/STI cumulative incidence over time | Participants will be tested for HIV, chlamydia and gonorrhea at each study visit. | Baseline, 6 month, 12 month, 18 month, 24 month visits. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Risk Behaviors | Participants will be asked for detailed information about sexual partners in the last 6 months. For each listed partner, the investigators will ask: gender; age; drug use; incarceration history; type of partner (primary, casual, one-time); frequency of sexual activity and condom use; type of sex (oral, vaginal, anal); and if partner had other sexual partners during the time of their sexual involvement. This data collection method allows for calculation of the number of unprotected sexual acts. | Baseline, 6 month, 12 month, 18 month visits. | 
| Illicit Drug Use | The investigators will ascertain the initiation and frequency of all illicit drugs through the use of a modified NIDA Risk Assessment Battery that has been used and adapted over the past decade. | Baseline, 6 month, 12 month, 18 month visits. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Sex work, STI