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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02677025
Acronym
YWHC
Enrollment
100
Registered
2016-02-09
Start date
2014-05-31
Completion date
2016-04-30
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Substance Abuse

Keywords

HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence and Victimization

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.

Interventions

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.

BEHAVIORALHIV Counseling/Testing

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

Sponsors

Medical Research Council, South Africa
CollaboratorOTHER
RTI International
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 21 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Unprotected intercourse among womenOne month post-interventionPercentages of condom use at last sex

Secondary

MeasureTime frameDescription
Alcohol useOne month post-interventionFrequency of alcohol use in past 30 days measured by RRBA (Revised Risk Behavior Assessment) and breath test
Substance useOne month post-interventionUse of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by PRBA (Pretoria Risk Behavior Assessment)
VictimizationOne month post-interventionPercentages of young women who report being beaten in the previous 30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026