<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04413591</url>
  </required_header>
  <id_info>
    <org_study_id>00007664</org_study_id>
    <secondary_id>1R01DA041243</secondary_id>
    <nct_id>NCT04413591</nct_id>
  </id_info>
  <brief_title>A Structural HIV Prevention Intervention Targeting High-risk Women</brief_title>
  <acronym>EMERALD</acronym>
  <official_title>A Structural HIV Prevention Intervention Targeting High-risk Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness of a community based combination HIV&#xD;
      prevention package, including biomedical, behavioral, and structural services for female sex&#xD;
      workers (FSW) in Baltimore, Maryland. This study is a prospective two-group trial comparing&#xD;
      the efficacy of a community-based comprehensive HIV/STI prevention package compared to&#xD;
      standard of care (HIV testing, counseling, and referrals) among FSWs. Outcomes will be&#xD;
      assessed through self-reported illicit drug use and sexual risk behaviors (behavioral) as&#xD;
      well as HIV/STI testing (biological).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims:&#xD;
&#xD;
        1. To examine the effect of exposure to community intervention components on HIV/STI risk&#xD;
           behaviors (e.g., drug use/unprotected sex), and HIV/STI cumulative incidence over time&#xD;
           in FSWs in the intervention (n=275) compared to those in the comparison group (N=175);&#xD;
&#xD;
           a. to explore the intervention's effects on the risk environment of exotic dance clubs&#xD;
           (N=15) over time&#xD;
&#xD;
        2. To examine how socio-structural (e.g., social cohesion, stigma) and structural&#xD;
           vulnerability (e.g., financial and housing stability) indicators change and are&#xD;
           associated with the biological and behavioral outcomes over time in FSWs in the&#xD;
           intervention (n=275) compared to those in the comparison (n=175) group&#xD;
&#xD;
           a. examine the role of these indicators as mediators of the intervention effect on study&#xD;
           outcomes;&#xD;
&#xD;
        3. To examine the intervention's implementation through qualitative (e.g., in-depth&#xD;
           interviews) and quantitative (e.g., assessment of program fit, reach, facilitators,&#xD;
           barriers, program costs) measures.&#xD;
&#xD;
      3.1 To examine participant knowledge of the COVID-19 crisis as well as the impact of the&#xD;
      crisis on their mental, and physical well-being.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Actual">September 22, 2020</completion_date>
  <primary_completion_date type="Actual">September 22, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HIV/STI cumulative incidence over time</measure>
    <time_frame>Baseline, 6 month, 12 month, 18 month, 24 month visits.</time_frame>
    <description>Participants will be tested for HIV, chlamydia and gonorrhea at each study visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sexual Risk Behaviors</measure>
    <time_frame>Baseline, 6 month, 12 month, 18 month visits.</time_frame>
    <description>Participants will be asked for detailed information about sexual partners in the last 6 months.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illicit Drug Use</measure>
    <time_frame>Baseline, 6 month, 12 month, 18 month visits.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Implementation evaluation using SPARC Center client satisfaction surveys</measure>
    <time_frame>12-month, 18-month</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Implementation evaluation using in-depth interviews with SPARC staff and clients</measure>
    <time_frame>18 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Implementation evaluation using cross-sectional surveys</measure>
    <time_frame>18 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">385</enrollment>
  <condition>Sex Work</condition>
  <arm_group>
    <arm_group_label>Intervention Area</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are assigned to the intervention area or the control area based on the location they were recruited in.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Area</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants are assigned to the intervention area or the control area based on the location they were recruited in.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community based combination HIV prevention package</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention Area</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older;&#xD;
&#xD;
          -  Assigned female at birth and identify with female gender&#xD;
&#xD;
          -  Have exchanged sex in Baltimore City at least 3 times in the past 3 months;&#xD;
&#xD;
          -  Willing to undergo testing for HIV, gonorrhea, and chlamydia&#xD;
&#xD;
          -  Willing to provide locator information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent in English;&#xD;
&#xD;
          -  Women who are determined as too high or drunk;&#xD;
&#xD;
          -  Women who are cognitively impaired.&#xD;
&#xD;
          -  Currently enrolled in the SAPPHIRE study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Assigned female at birth and identify with female gender</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Sherman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Bloomberg School of Public Health</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>October 4, 2022</last_update_submitted>
  <last_update_submitted_qc>October 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sex work</keyword>
  <keyword>HIV</keyword>
  <keyword>STI</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04413591
org study id: 00007664
secondary id: 1R01DA041243
nct id: NCT04413591
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in HIV/STI cumulative incidence over time
time frame: Baseline, 6 month, 12 month, 18 month, 24 month visits.
description: Participants will be tested for HIV, chlamydia and gonorrhea at each study visit.
measure: Sexual Risk Behaviors
time frame: Baseline, 6 month, 12 month, 18 month visits.
description: 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.
measure: Illicit Drug Use
time frame: Baseline, 6 month, 12 month, 18 month visits.
description: 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.
measure: Implementation evaluation using SPARC Center client satisfaction surveys
time frame: 12-month, 18-month
description: 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.
measure: Implementation evaluation using in-depth interviews with SPARC staff and clients
time frame: 18 months
description: 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.
measure: Implementation evaluation using cross-sectional surveys
time frame: 18 months
description: 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.
arm group label: Intervention Area
arm group type: Experimental
description: Participants are assigned to the intervention area or the control area based on the location they were recruited in.
arm group label: Control Area
arm group type: No Intervention
description: Participants are assigned to the intervention area or the control area based on the location they were recruited in.
intervention type: Behavioral
intervention name: Community based combination HIV prevention package
description: 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.
arm group label: Intervention Area
criteria: 
gender: Female
gender based: Yes
gender description: Assigned female at birth and identify with female gender
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan Sherman
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No