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

Not Applicable

Completed

• Conditions: Substance Abuse; HIV
• Interventions: Behavioral: Young Women's Health CoOp (YWHC); Behavioral: HIV Counseling/Testing

• Registration Number: NCT02677025
• Lead Sponsor: RTI International

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 Timeline

• Study Start: 2014-05
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-09
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Young Women's Health CoOp (YWHC)	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.
HIV Counseling/Testing	HIV Counseling/Testing	Provide age and gender appropriate standard HIV counseling and testing.

Primary Outcome Measures

Name	Time	Method
Unprotected intercourse among women	One month post-intervention	Percentages of condom use at last sex

Secondary Outcome Measures

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

Trial Locations

Locations (1)

RTI International; 🇺🇸 Research Triangle Park, North Carolina, United States