A Structural HIV Prevention Intervention Targeting High-risk Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-14

Study Completion Date

2020-09-22

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).

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Detailed Description

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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.

Conditions

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Sex Work

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Area

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Group Type EXPERIMENTAL

Community based combination HIV prevention package

Intervention Type BEHAVIORAL

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.

Control Area

Participants are assigned to the intervention area or the control area based on the location they were recruited in.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Community based combination HIV prevention package

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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No