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

June 7, 2016 updated by: RTI International

Seek, Test, Treat, & Retain Pilot for Out of School Teens at Risk in Cape Town

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.

Study Overview

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

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Research Triangle Park, North Carolina, United States, 27709
        • RTI International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Active Comparator: HIV Counseling/Testing
Provide age and gender appropriate standard HIV counseling and testing.
Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unprotected intercourse among women
Time Frame: One month post-intervention
Percentages of condom use at last sex
One month post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One month post-intervention
Alcohol use
Time Frame: One month post-intervention
Frequency of alcohol use in past 30 days measured by breath test
One month post-intervention
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)
One month post-intervention
Substance use
Time Frame: One month post-intervention
Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by self-report
One month post-intervention
Victimization
Time Frame: One month post-intervention
Percentages of young women who report being beaten in the previous 30 days
One month post-intervention
Victimization
Time Frame: One month post-intervention
Percentages of young women who report being attacked with a weapon in the previous 30 days
One month post-intervention
Victimization
Time Frame: One month post-intervention
Percentages of young women who report being forced to have sex in the previous 30 days
One month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wendee M Wechsberg, PhD, Director of RTI Global Gender Center, Senior Director of SATEI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 7, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • R01DA032061 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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