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 range18 Years – 45 Years

SexFEMALE

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

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

Timeframe: 6-months post-enrollment

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 range18 Years – 45 Years

SexFEMALE

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

Timeframe: 6-months post-enrollment