A Structural HIV Prevention Intervention Targeting High-risk Women (EMERALD)

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Sex Work

Treatments: Behavioral: Community based combination HIV prevention package

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04413591

00007664

1R01DA041243 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 385 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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385 participants in 2 patient groups

Intervention Area

Experimental group

Description:

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

Treatment:

Behavioral: Community based combination HIV prevention package

Control Area

No Intervention group

Description:

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