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

Johns Hopkins Bloomberg School of Public Health logo

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)

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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