<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/NCT02974998</url>
  </required_header>
  <id_info>
    <org_study_id>R01DA041227</org_study_id>
    <nct_id>NCT02974998</nct_id>
  </id_info>
  <brief_title>Cape Town Young Women's Health CoOp</brief_title>
  <official_title>Expanding HIV Testing and Prevention to Reach Vulnerable Young Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RTI International</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Research Council, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RTI International</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This two-arm cluster randomized trial tested a gender-focused comprehensive HIV testing and&#xD;
      counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program&#xD;
      and targeted female adolescents (aged 16-19) who use substances and have dropped out of&#xD;
      school. To evaluate the process, the study examined the feasibility of using peer role models&#xD;
      as recruiters and co-facilitators of the intervention and monitored fidelity to the&#xD;
      intervention. Efficacy of the intervention on behavioral and biological outcomes, and on&#xD;
      linkages to health services, through follow-up visits conducted 6- and 12-months&#xD;
      post-enrollment was also assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study was to test a gender-focused comprehensive HIV testing and&#xD;
      counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program&#xD;
      in 24 disadvantaged communities in Cape Town, South Africa. The researchers conducted&#xD;
      community-level randomization across the 24 communities with balanced recruitment from&#xD;
      predominantly Black African and predominantly Coloured communities. The aims of the study&#xD;
      were: Aim 1. To train and evaluate adolescent peer role models to conduct community outreach&#xD;
      with established outreach workers to recruit 500 out-of-school, substance-using female&#xD;
      adolescents aged 16 to 19 for HIV testing and counseling (HTC) and to co-facilitate a&#xD;
      gender-focused comprehensive HTC program. Aim 2. To test the efficacy of a young women's&#xD;
      gender-focused comprehensive HTC program for reducing substance use, victimization, and&#xD;
      sexual risk behavior (primary outcomes) and improving access to effective treatment and&#xD;
      support services through linkages to care (substance abuse treatment, HIV, sexually&#xD;
      transmitted infections [STIs], antenatal and reproductive health as secondary outcomes)&#xD;
      relative to standard HTC for adolescent females. The Young Women's Health CoOp has been&#xD;
      adapted from the South African Women's Health CoOp (WHC) and the North Carolina Young Women's&#xD;
      CoOp (YWC) which was found acceptable in focus groups and maintained all the core elements of&#xD;
      the evidence-based intervention. For this study, the intervention was co-facilitated by&#xD;
      trained staff from the local communities. The intervention consisted of two 1.5-hour group&#xD;
      workshops (sessions), each having several modules that are usually administered a week apart:&#xD;
      Workshop 1: Developmental Issues and Alcohol and Other Drugs; Gender, Problem-Solving and&#xD;
      Conflict Negotiation, Violence and Values and Becoming a Powerful Young Woman: and Workshop&#xD;
      2: STIs, HIV/AIDS, Prevention, Condoms and Role-play. After each session, each participant&#xD;
      developed a risk-reduction personalized action plan (PAP). To maintain PAP goals and reduce&#xD;
      decay of intervention effects over time, the staff conducted case management to help&#xD;
      participants attain these personal goals. Participants completed baseline, 6-month follow-up&#xD;
      and 12-month follow-up assessments, which included a survey and biological testing for&#xD;
      substance use, pregnancy and HIV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">November 26, 2019</completion_date>
  <primary_completion_date type="Actual">November 26, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduced Sexual Risk</measure>
    <time_frame>Baseline</time_frame>
    <description>Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduced Sexual Risk</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduced Sexual Risk</measure>
    <time_frame>12 months after baseline</time_frame>
    <description>Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Increased Condom Use</measure>
    <time_frame>Baseline</time_frame>
    <description>Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Increased Condom Use</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Increased Condom Use</measure>
    <time_frame>12 months after baseline</time_frame>
    <description>Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduced Alcohol and Illicit Drug Use</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduced Alcohol and Illicit Drug Use</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduced Alcohol and Illicit Drug Use</measure>
    <time_frame>12 months after baseline</time_frame>
    <description>Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduced Violence and Victimization</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduced Violence and Victimization</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduced Violence and Victimization</measure>
    <time_frame>12 months after baseline</time_frame>
    <description>Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Increased Access to Health Services</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-reported use of sexual reproductive health and HIV &amp; STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increased Access to Health Services</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>Self-reported use of sexual reproductive health and HIV &amp; STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increased Access to Health Services</measure>
    <time_frame>12 months after baseline</time_frame>
    <description>Self-reported use of sexual reproductive health and HIV &amp; STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increased Advancement in Education and Job Training</measure>
    <time_frame>Baseline</time_frame>
    <description>Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increased Advancement in Education and Job Training</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increased Advancement in Education and Job Training</measure>
    <time_frame>12 months after baseline</time_frame>
    <description>Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Condomless Sex</condition>
  <condition>Human Immunodeficiency Virus (HIV)</condition>
  <condition>Sexually Transmitted Infections (STIs)</condition>
  <condition>Alcohol and Drug Use</condition>
  <condition>Violence and Victimization</condition>
  <condition>Access and Linkage to Healthcare</condition>
  <condition>Education Advancement</condition>
  <arm_group>
    <arm_group_label>Young Women's Health CoOp (YWHC)/ HTC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received an enhanced gender-focused HTC intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard HTC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received the standard HTC available in South Africa for this population.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Young Women's Health CoOp (YWHC)</intervention_name>
    <description>Participants received HTC and engaged in a two-session gender-focused intervention. The intervention included information addressing the intersection of substance use, sexual risk, and violence through skill building, role-play, and rehearsal. The intervention also encouraged positive goal-seeking to access linkages to health care within the larger social ecological framework of where the young women live.</description>
    <arm_group_label>Young Women's Health CoOp (YWHC)/ HTC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard HTC</intervention_name>
    <description>Participants received the standard HTC available in South Africa for this population.</description>
    <arm_group_label>Standard HTC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Self-identify as living in one of the 24 targeted disadvantaged communities&#xD;
&#xD;
          -  Between 16 and 19 years old&#xD;
&#xD;
          -  Has dropped out of school for at least 6 months&#xD;
&#xD;
          -  Is currently dropped out of school&#xD;
&#xD;
          -  Has not completed matric (high school diploma) or have an N3 Certificate (South Africa&#xD;
             National Technical Certificate)&#xD;
&#xD;
          -  Reports consuming 2-3 alcoholic drinks at least once in the last 30 days or using&#xD;
             illicit drugs at least once a week.&#xD;
&#xD;
          -  Reports unprotected sex with a male partner in the last 90 days&#xD;
&#xD;
          -  Is able to provide informed assent to participate or informed consent if emancipated&#xD;
             or 18 years old&#xD;
&#xD;
          -  Has lived in targeted community for at least 6 months and plans to reside in the&#xD;
             target community for the next year and provide verifiable locator information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant must be able to pass a cognitive test&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wendee Wechsberg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RTI International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The South African Medical Research Council (SAMRC),</name>
      <address>
        <city>Cape Town</city>
        <zip>7501</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6042235/</url>
    <description>The Young Women's Health CoOp in Cape Town, South Africa: Study protocol for a cluster-randomised trial for adolescent women at risk for HIV</description>
  </link>
  <reference>
    <citation>Wechsberg WM, Browne FA, Carney T, Myers B, Minnis A, MacDonald R, Ndirangu JW, Turner LB, Howard BN, Rodman N. The Young Women's Health CoOp in Cape Town, South Africa: Study protocol for a cluster-randomised trial for adolescent women at risk for HIV. BMC Public Health. 2018 Jul 11;18(1):859. doi: 10.1186/s12889-018-5665-5.</citation>
    <PMID>29996792</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Human Immunodeficiency Virus (HIV)</keyword>
  <keyword>HIV Testing and Counseling (HTC)</keyword>
  <keyword>Sexually Transmitted Infections (STIs)</keyword>
  <keyword>Substance Abuse</keyword>
  <keyword>Gender Based Violence</keyword>
  <keyword>Gang Violence</keyword>
  <keyword>Victimization</keyword>
  <keyword>Linkage to Care</keyword>
  <keyword>Sexual Risk</keyword>
  <keyword>Out-of-school Adolescents</keyword>
  <keyword>Young Women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Sexually Transmitted Diseases</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <!-- 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/NCT02974998
org study id: R01DA041227
nct id: NCT02974998
lead sponsor: 
collaborator: 
has dmc: Yes
This two-arm cluster randomized trial tested a gender-focused comprehensive HIV testing and
      counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program
      and targeted female adolescents (aged 16-19) who use substances and have dropped out of
      school. To evaluate the process, the study examined the feasibility of using peer role models
      as recruiters and co-facilitators of the intervention and monitored fidelity to the
      intervention. Efficacy of the intervention on behavioral and biological outcomes, and on
      linkages to health services, through follow-up visits conducted 6- and 12-months
      post-enrollment was also assessed.
The purpose of this study was to test a gender-focused comprehensive HIV testing and
      counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program
      in 24 disadvantaged communities in Cape Town, South Africa. The researchers conducted
      community-level randomization across the 24 communities with balanced recruitment from
      predominantly Black African and predominantly Coloured communities. The aims of the study
      were: Aim 1. To train and evaluate adolescent peer role models to conduct community outreach
      with established outreach workers to recruit 500 out-of-school, substance-using female
      adolescents aged 16 to 19 for HIV testing and counseling (HTC) and to co-facilitate a
      gender-focused comprehensive HTC program. Aim 2. To test the efficacy of a young women's
      gender-focused comprehensive HTC program for reducing substance use, victimization, and
      sexual risk behavior (primary outcomes) and improving access to effective treatment and
      support services through linkages to care (substance abuse treatment, HIV, sexually
      transmitted infections [STIs], antenatal and reproductive health as secondary outcomes)
      relative to standard HTC for adolescent females. The Young Women's Health CoOp has been
      adapted from the South African Women's Health CoOp (WHC) and the North Carolina Young Women's
      CoOp (YWC) which was found acceptable in focus groups and maintained all the core elements of
      the evidence-based intervention. For this study, the intervention was co-facilitated by
      trained staff from the local communities. The intervention consisted of two 1.5-hour group
      workshops (sessions), each having several modules that are usually administered a week apart:
      Workshop 1: Developmental Issues and Alcohol and Other Drugs; Gender, Problem-Solving and
      Conflict Negotiation, Violence and Values and Becoming a Powerful Young Woman: and Workshop
      2: STIs, HIV/AIDS, Prevention, Condoms and Role-play. After each session, each participant
      developed a risk-reduction personalized action plan (PAP). To maintain PAP goals and reduce
      decay of intervention effects over time, the staff conducted case management to help
      participants attain these personal goals. Participants completed baseline, 6-month follow-up
      and 12-month follow-up assessments, which included a survey and biological testing for
      substance use, pregnancy and HIV.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Reduced Sexual Risk
time frame: Baseline
description: Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment)
measure: Reduced Sexual Risk
time frame: 6 months after baseline
description: Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment
measure: Reduced Sexual Risk
time frame: 12 months after baseline
description: Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment
measure: Increased Condom Use
time frame: Baseline
description: Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)
measure: Increased Condom Use
time frame: 6 months after baseline
description: Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)
measure: Increased Condom Use
time frame: 12 months after baseline
description: Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)
measure: Reduced Alcohol and Illicit Drug Use
time frame: Baseline
description: Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests.
measure: Reduced Alcohol and Illicit Drug Use
time frame: 6 months after baseline
description: Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests.
measure: Reduced Alcohol and Illicit Drug Use
time frame: 12 months after baseline
description: Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests.
measure: Reduced Violence and Victimization
time frame: Baseline
description: Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
measure: Reduced Violence and Victimization
time frame: 6 months after baseline
description: Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
measure: Reduced Violence and Victimization
time frame: 12 months after baseline
description: Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
measure: Increased Access to Health Services
time frame: Baseline
description: Self-reported use of sexual reproductive health and HIV & STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation.
measure: Increased Access to Health Services
time frame: 6 months after baseline
description: Self-reported use of sexual reproductive health and HIV & STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation.
measure: Increased Access to Health Services
time frame: 12 months after baseline
description: Self-reported use of sexual reproductive health and HIV & STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation.
measure: Increased Advancement in Education and Job Training
time frame: Baseline
description: Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
measure: Increased Advancement in Education and Job Training
time frame: 6 months after baseline
description: Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
measure: Increased Advancement in Education and Job Training
time frame: 12 months after baseline
description: Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
arm group label: Young Women's Health CoOp (YWHC)/ HTC
arm group type: Experimental
description: Participants received an enhanced gender-focused HTC intervention.
arm group label: Standard HTC
arm group type: Active Comparator
description: Participants received the standard HTC available in South Africa for this population.
intervention type: Behavioral
intervention name: Young Women's Health CoOp (YWHC)
description: Participants received HTC and engaged in a two-session gender-focused intervention. The intervention included information addressing the intersection of substance use, sexual risk, and violence through skill building, role-play, and rehearsal. The intervention also encouraged positive goal-seeking to access linkages to health care within the larger social ecological framework of where the young women live.
arm group label: Young Women's Health CoOp (YWHC)/ HTC
intervention type: Behavioral
intervention name: Standard HTC
description: Participants received the standard HTC available in South Africa for this population.
arm group label: Standard HTC
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wendee Wechsberg, PhD
role: Principal Investigator
affiliation: RTI International
facility: 
country: South Africa
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6042235/
description: The Young Women's Health CoOp in Cape Town, South Africa: Study protocol for a cluster-randomised trial for adolescent women at risk for HIV
citation: Wechsberg WM, Browne FA, Carney T, Myers B, Minnis A, MacDonald R, Ndirangu JW, Turner LB, Howard BN, Rodman N. The Young Women's Health CoOp in Cape Town, South Africa: Study protocol for a cluster-randomised trial for adolescent women at risk for HIV. BMC Public Health. 2018 Jul 11;18(1):859. doi: 10.1186/s12889-018-5665-5.
PMID: 29996792
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Sexually Transmitted Diseases
mesh term: Immunologic Deficiency Syndromes