CompletedNot Applicable

Implementation Research for Vulnerable Women in South Africa

United States, South Africa564 participantsStarted 2015-09

Plain-language summary

This study sought to implement the Women's Health CoOp (Cooperative) (WHC) intervention into healthcare, antenatal, and substance treatment clinics in South Africa and translated this evidence-based intervention into real-world settings. Implementation, service, and patient outcomes will be evaluated through an iterative stepped wedge design.

Who can participate

Age range

18 Years – 45 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.

Clinic Inclusion Criteria: * HIV/antenatal clinic or substance abuse treatment clinic * Located in townships surrounding Cape Town * Willing to take part in study Patient Inclusion Criteria: * Female; * 18 to 45 years of age; * Reports use of at least one drug, including alcohol, at least weekly during the previous 3 months; * Reports unprotected sex with a male partner in the past 6 months; * Has a positive HIV test result from either the participating health clinic or rehab clinic, or a clinic issued ARV card or ARV medication as proof of positive status; * Reports the intention to remain in the area for at least the next 6 months; * Provides informed consent to participate. Patient Exclusion Criteria: * Not HIV Positive * Not willing to do alcohol and drug screening

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

Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)

Timeframe: Baseline

Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)

Timeframe: 6-months post-enrollment

Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)

Timeframe: Baseline

Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention

Timeframe: Baseline

Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention

Timeframe: 6-months post-enrollment

Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention

Timeframe: Baseline

Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention

Trial details

NCT IDNCT02733003

SponsorRTI International

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-04

View on ClinicalTrials.gov More HIV trials

Plain-language summary

Who can participate

Age range

18 Years – 45 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

Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)

Timeframe: Baseline

Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)

Timeframe: 6-months post-enrollment

Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)

Timeframe: Baseline

Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention

Timeframe: Baseline

Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention

Timeframe: 6-months post-enrollment

Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention

Timeframe: Baseline

Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention