CompletedNot Applicable

Treating South African Pregnant Women for Methamphetamine

South Africa60 participantsStarted 2011-07

Plain-language summary

The purpose of this study was to develop and initially evaluate an efficacious, comprehensive, culturally sensitive, women-centered model of care for pregnant South African women by adapting and refining PI Jones' Reinforcement-Based Treatment (RBT) model, at the same time integrating into it the HIV prevention components of Co-I Wechsberg's Women's Health CoOp (WHC) model, yielding an integrated treatment and prevention model, RBT+WHC.

Who can participate

Age range

18 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: * are 18 years of age or older * self-identify as "Coloured" (this is a cultural grouping of people with mixed-race ancestry) * live in the Cape Town township communities of Mitchell's Plain, Delft, Elsie's River, Belhar, Bishop Lavis, or Ravensmead * meet current DSM-IV criteria for methamphetamine abuse or dependence * are willing to enter drug abuse treatment * report unprotected sex in the past 30 days * are HIV negative * provide verifiable locator information for follow-up interview * are 20-28 weeks pregnant, inclusive, and determined by last menstrual period Exclusion Criteria: * are male * are younger than 18 years * do not self-identify as "Coloured" * do not live in the Cape Town township communities of Mitchell's Plain, Delft, Elsie's River, Belhar, Bishop Lavis, or Ravensmead * do not meet current DSM-IV criteria for methamphetamine abuse or dependence * are not willing to enter drug abuse treatment * have not reported unprotected sex in the past 30 days * are HIV positive * do not provide verifiable locator information for follow-up interview * are not 20-28 weeks pregnant * are not able to provide informed consent

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

Methamphetamine practices

Timeframe: 3 months after randomization

Prenatal care

Timeframe: At time of delivery

Length of hospital stay

Timeframe: At time of delivery

Trial details

NCT IDNCT01386138

SponsorRTI International

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-06

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