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Completed

NCT Number: NCT02677025

Young Women's Health CoOp (Cooperative) 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.

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Key information

Age range

16 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

RTI International

Research Triangle Park, North Carolina, 27709, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Young Women's Health CoOp (YWHC)

Behavioral

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.

HIV Counseling/Testing

Behavioral

Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.

Primary outcomes

  1. Unprotected intercourse among women

    Time frame: One month post-intervention

    Percentages of condom use at last sex

Secondary outcomes

  1. 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

  2. Alcohol use

    Time frame: One month post-intervention

    Frequency of alcohol use in past 30 days measured by breath test

  3. 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)

  4. Substance use

    Time frame: One month post-intervention

    Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by self-report

  5. Victimization

    Time frame: One month post-intervention

    Percentages of young women who report being beaten in the previous 30 days

  6. Victimization

    Time frame: One month post-intervention

    Percentages of young women who report being attacked with a weapon in the previous 30 days

  7. Victimization

    Time frame: One month post-intervention

    Percentages of young women who report being forced to have sex in the previous 30 days

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • Medical Research Council, South Africa

Registry information

Official study title

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

Acronym: YWHC

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2016
Registry last updated
Jan 8, 2025

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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