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Completed

NCT Number: NCT04413591

A Structural HIV Prevention Intervention Targeting High-risk Women

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).

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Key information

Conditions

Sex Work Behavior Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Behavior Sexually Transmitted Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community based combination HIV prevention package

Behavioral

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.

Primary outcomes

  1. Change in HIV/STI cumulative incidence over time

    Time frame: Baseline, 6 month, 12 month, 18 month, 24 month visits.

    Participants will be tested for HIV, chlamydia and gonorrhea at each study visit.

Secondary outcomes

  1. Sexual Risk Behaviors

    Time frame: Baseline, 6 month, 12 month, 18 month visits.

    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.

  2. Illicit Drug Use

    Time frame: Baseline, 6 month, 12 month, 18 month visits.

    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.

Other outcomes

  1. Implementation evaluation using SPARC Center client satisfaction surveys

    Time frame: 12-month, 18-month

    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.

  2. Implementation evaluation using in-depth interviews with SPARC staff and clients

    Time frame: 18 months

    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.

  3. Implementation evaluation using cross-sectional surveys

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: EMERALD

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2020
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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