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Young Women's Health CoOp (Cooperative) in Cape Town (YWHC)

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ClinicalTrials.gov Identifier: NCT02677025
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : June 9, 2016
Sponsor:
Collaborator:
Medical Research Council, South Africa
Information provided by (Responsible Party):
RTI International

Tracking Information
First Submitted Date  ICMJE January 19, 2016
First Posted Date  ICMJE February 9, 2016
Last Update Posted Date June 9, 2016
Study Start Date  ICMJE May 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
Unprotected intercourse among women [ Time Frame: One month post-intervention ]
Percentages of condom use at last sex
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • Alcohol use [ Time Frame: One month post-intervention ]
    Frequency of alcohol use in past 30 days measured by RRBA (Revised Risk Behavior Assessment) and breath test
  • Alcohol use [ Time Frame: One month post-intervention ]
    Frequency of alcohol use in past 30 days measured by breath test
  • Substance use [ Time Frame: One month post-intervention ]
    Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by PRBA (Pretoria Risk Behavior Assessment)
  • Substance use [ Time Frame: One month post-intervention ]
    Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by self-report
  • Victimization [ Time Frame: One month post-intervention ]
    Percentages of young women who report being beaten in the previous 30 days
  • Victimization [ Time Frame: One month post-intervention ]
    Percentages of young women who report being attacked with a weapon in the previous 30 days
  • Victimization [ Time Frame: One month post-intervention ]
    Percentages of young women who report being forced to have sex in the previous 30 days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Young Women's Health CoOp (Cooperative) in Cape Town
Official Title  ICMJE Seek, Test, Treat, & Retain Pilot for Out of School Teens at Risk in Cape Town
Brief Summary This supplement study is an adaptation of the larger NIH-funded parent study, the Women's Health CoOp+, which tests a combination biobehavioral HIV prevention approach to enhance standard HIV testing practices for alcohol and drug (AOD)-using women across the city of Pretoria, South Africa. The current supplemental study seeks to reach AOD-using female adolescents who experience the greatest burden of new HIV infections and are currently underserved by HIV and drug-treatment programs in Cape Town, South Africa and test the validation of both the instrument and adapted intervention.
Detailed Description

This study is testing and validating both the revised instrument and adapted intervention through a small pilot trial where a cluster randomized design is used to recruit 100 participants through snowball sampling by community to either the YWHC condition or standard HIV Counseling and Testing (HCT); collect biological specimens to screen for recent drug use, pregnancy and HIV infection and provide referrals for care to resources; conduct process evaluation measures for satisfaction and a 1-month follow-up post-intervention interview assessing the feasibility and preliminary efficacy of conducting this intervention among vulnerable young women and linking them to care.

Young women from disadvantaged communities in Cape Town who have dropped out of school and who use AODs are highly vulnerable to physical victimization (violence and sexual victimization) from any perpetrator, including main sexual partners and drug-related sexual risks for HIV. Yet these vulnerable young women remain underserved by current HIV and drug treatment programs in the region, even though they are experiencing the greatest burden of new HIV infections in the country. The adapted Young Women's Health CoOp (YWHC) intervention has a high likelihood of wider implementation, sustainability, and a significant public health impact by reducing the exceedingly high HIV incidence amongst the most vulnerable populations in South Africa.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV
  • Substance Abuse
Intervention  ICMJE
  • Behavioral: Young Women's Health CoOp (YWHC)
    Participants in this group will participate in two workshops of the young woman-focused intervention about HIV/STIs (sexually transmitted infections), sexual behaviors, alcohol and other drug use, violence, communication skills, and other issues. Participants will develop personalized risk reduction action plans at the end of each workshop session.
  • Behavioral: HIV Counseling/Testing
    Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.
Study Arms  ICMJE
  • Experimental: Young Women's Health CoOp (YWHC)
    This is an adapted behavioral intervention for young women in Cape Town South Africa who dropped out of school, who use alcohol and other drugs and are at risk for HIV.
    Intervention: Behavioral: Young Women's Health CoOp (YWHC)
  • Active Comparator: HIV Counseling/Testing
    Provide age and gender appropriate standard HIV counseling and testing.
    Intervention: Behavioral: HIV Counseling/Testing
Publications * Carney T, Browne FA, Myers B, Kline TL, Howard B, Wechsberg WM. Adolescent female school dropouts who use drugs and engage in risky sex: effects of a brief pilot intervention in Cape Town, South Africa. AIDS Care. 2019 Jan;31(1):77-84. doi: 10.1080/09540121.2018.1500008. Epub 2018 Jul 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female, 16 to 21 years of age
  • Dropped out of school for at least 6 months
  • Currently dropped out of school
  • Have not completed matric or N 3 certificate
  • Have used at least one drug (which can include alcohol) at least weekly in the past 90 days
  • Report unprotected sex with a male partner in the last 90 days
  • Able to provide informed assent to participate or informed consent if at least 18 years old
  • Live in a targeted community Delft, Khayelitsha, or Mfuleni

Exclusion Criteria:

• Have been a part of formative activities

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02677025
Other Study ID Numbers  ICMJE R01DA032061( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: After the main findings are published, we welcome other researchers who want to analyze the data in other ways. Before this time, however, we anticipate establishing a publication plan that involves other researchers and institutions. Analytic data sets will be prepared in accordance with the "Privacy Rule" of the Health Insurance Portability and Accountability Act (HIPAA; http://www.hhs.gov/ocr/) as "limited data sets" in which names and other personal health identifiers are removed, birthdays have been converted to age at intake, and other dates have been changed to be days before or after the date of intake.
Responsible Party RTI International
Study Sponsor  ICMJE RTI International
Collaborators  ICMJE Medical Research Council, South Africa
Investigators  ICMJE
Principal Investigator: Wendee M Wechsberg, PhD Director of RTI Global Gender Center, Senior Director of SATEI
PRS Account RTI International
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP