A Structural HIV Prevention Intervention Targeting High-risk Women

Sex Work Clinical Trial

— EMERALD  

Official title:

A Structural HIV Prevention Intervention Targeting High-risk Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413591
• Other study ID #: 00007664
• Secondary ID: 1R01DA041243
• Status: Completed
• Phase: N/A
• Start date: September 14, 2017
• Est. completion date: September 22, 2020

Study information

• Verified date: October 2022
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: September 22, 2020
• Est. primary completion date: September 22, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sex Work

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implementation evaluation using SPARC Center client satisfaction surveys	SPARC Center client satisfaction surveys will be used to determine the fit, facilitators and barriers, quality, and general experience of women who have used the SPARC Center.	12-month, 18-month
Other	Implementation evaluation using in-depth interviews with SPARC staff and clients	An in-depth interview guide will be developed by experienced study staff and used to interview SPARC guests and staff with the goal of examining program reach, fit, facilitators and barriers, and program costs.	18 months
Other	Implementation evaluation using cross-sectional surveys	A cross-sectional survey will be developed by study staff and used to determine the reach of the implementation within the FSW community of southwest Baltimore.	18 months
Primary	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	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.
Secondary	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.