CompletedNot Applicable

Cape Town Young Women's Health CoOp

South Africa500 participantsStarted 2016-11

Plain-language summary

This two-arm cluster randomized trial tested a gender-focused comprehensive HIV testing and counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program and targeted female adolescents (aged 16-19) who use substances and have dropped out of school. To evaluate the process, the study examined the feasibility of using peer role models as recruiters and co-facilitators of the intervention and monitored fidelity to the intervention. Efficacy of the intervention on behavioral and biological outcomes, and on linkages to health services, through follow-up visits conducted 6- and 12-months post-enrollment was also assessed.

Who can participate

Age range

16 Years – 19 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female * Self-identify as living in one of the 24 targeted disadvantaged communities * Between 16 and 19 years old * Has dropped out of school for at least 6 months * Is currently dropped out of school * Has not completed matric (high school diploma) or have an N3 Certificate (South Africa National Technical Certificate) * Reports consuming 2-3 alcoholic drinks at least once in the last 30 days or using illicit drugs at least once a week. * Reports unprotected sex with a male partner in the last 90 days * Is able to provide informed assent to participate or informed consent if emancipated or 18 years old * Has lived in targeted community for at least 6 months and plans to reside in the target community for the next year and provide verifiable locator information Exclusion Criteria: * Participant must be able to pass a cognitive test

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduced Sexual Risk

Timeframe: Baseline

Reduced Sexual Risk

Timeframe: 6 months after baseline

Reduced Sexual Risk

Timeframe: 12 months after baseline

Increased Condom Use

Timeframe: Baseline

Increased Condom Use

Timeframe: 6 months after baseline

Increased Condom Use

Timeframe: 12 months after baseline

Reduced Alcohol and Illicit Drug Use

Timeframe: Baseline

Reduced Alcohol and Illicit Drug Use

Timeframe: 6 months after baseline

Trial details

NCT IDNCT02974998

SponsorRTI International

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-26

View on ClinicalTrials.gov More Condomless Sex trials

Plain-language summary

Who can participate

Age range

16 Years – 19 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Reduced Sexual Risk

Timeframe: Baseline

Reduced Sexual Risk

Timeframe: 6 months after baseline

Reduced Sexual Risk

Timeframe: 12 months after baseline

Increased Condom Use

Timeframe: Baseline

Increased Condom Use

Timeframe: 6 months after baseline

Increased Condom Use

Timeframe: 12 months after baseline

Reduced Alcohol and Illicit Drug Use

Timeframe: Baseline

Reduced Alcohol and Illicit Drug Use

Timeframe: 6 months after baseline