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

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).

Study Overview

• Status: Completed
• Conditions: Sex Work
• Intervention / Treatment: Behavioral: Community based combination HIV prevention package

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.

• Study Type: Interventional
• Enrollment (Actual): 385
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Bloomberg School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Area; Participants are assigned to the intervention area or the control area based on the location they were recruited in.	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.
No Intervention: Control Area; Participants are assigned to the intervention area or the control area based on the location they were recruited in.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Susan Sherman, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Actual): September 22, 2020
• Study Completion (Actual): September 22, 2020

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: HIV; STI; Sex work
• Other Study ID Numbers: 00007664; 1R01DA041243 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No