Clinical trial NCT04413591: A Structural HIV Prevention Intervention Targeting High-risk Women
Official title: A Structural HIV Prevention Intervention Targeting High-risk Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sex Work
Keywords: Sex work
HIV
STI
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-06-04
Enrollment: 385
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HIV/STI cumulative incidence over time
timeFrame: Baseline, 6 month, 12 month, 18 month, 24 month visits.
Secondary outcomes:
measure: Sexual Risk Behaviors
timeFrame: Baseline, 6 month, 12 month, 18 month visits.
measure: Illicit Drug Use
timeFrame: Baseline, 6 month, 12 month, 18 month visits.
Other outcomes:
measure: Implementation evaluation using SPARC Center client satisfaction surveys
timeFrame: 12-month, 18-month
measure: Implementation evaluation using in-depth interviews with SPARC staff and clients
timeFrame: 18 months
measure: Implementation evaluation using cross-sectional surveys
timeFrame: 18 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Susan Sherman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silberzahn BE, Tomko CA, Clouse E, Haney K, Allen ST, Galai N, Footer KHA, Sherman SG. The EMERALD (Enabling Mobilization, Empowerment, Risk Reduction, and Lasting Dignity) Study: Protocol for the Design, Implementation, and Evaluation of a Community-Based Combination HIV Prevention Intervention for Female Sex Workers in Baltimore, Maryland. JMIR Res Protoc. 2021 Apr 16;10(4):e23412. doi: 10.2196/23412.