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临床试验/NCT01386138
NCT01386138已完成不适用

Treating South African Pregnant Women for Methamphetamine

RTI International2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Methamphetamine practices

研究概览

简要总结

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.

详细描述

Cape Town is a striking example of the need for women-specific substance abuse treatment, as it is experiencing a devastating level of methamphetamine use (7% of the adult population),especially among women of childbearing age. The use of methamphetamine (hereafter referred to as "meth") is higher in Cape Town than anywhere else in the country. Consequently, there has been a critical need to develop and test a woman-focused intervention that reduces meth use in a highly vulnerable population of South African women.

Since 2001, the Women's Health CoOp (WHC; PI Wechsberg; RO1s DA011609S; AA014488; HD058320) has successfully adapted an evidence-based intervention to reduce sex- and drug-risk behaviors in drug-using South African women. However, with a rapid rise in meth use, the Western Cape is experiencing a new drug epidemic. A previous WHC study data indicated that the WHC had limited success in reducing the use of this among women. Alarmingly, among WHC participants, a greater proportion of pregnant than non-pregnant women reported using meth (n=24/26=92%; n=238/356=67%; p=.01). These findings are underscored by a lack of a focused and intensive treatment for meth-using pregnant women who live in impoverished townships. Thus, this project responded to PA-09-021 International Research Collaboration on Drug Abuse and Addiction Research (R21) by developing treatment options for meth use among pregnant women and using the long collaboration between WHC staff and local treatment providers to develop our first project to treat meth use in pregnant women.

The goal of this project was to develop and initially evaluate an efficacious, comprehensive, culturally sensitive, women-centred 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.

The study had two sequential aims: Aim 1: Adapt and pretest a comprehensive drug abuse treatment model, RBT, which integrated the evidence-based WHC HIV prevention model, to produce a comprehensive, culturally sensitive, woman-focused intervention for meth-using pregnant Coloured women, RBT+WHC. Aim 2: Conduct a small-scale randomized controlled trial (RCT) with pregnant Coloured women to determine the acceptability, feasibility, and initial efficacy of the RBT+WHC model relative to a psycho-educational control condition in terms of their respective impact on maternal outcomes, including (a) meth use, (b) frequency of unprotected sex acts, and (c) number of prenatal care visits; and neonatal outcomes including (d) length of hospital stay, (e) birth weight, and (f) gestational age at delivery. About 300 women were screened for the study but only 32 were found to eligible and completed the study.

The public health impact of this project was far-reaching. RBT+WHC aimed to fill a critical gap in substance use treatment research in a social structure where women are disproportionately disenfranchised from receiving healthcare compared with men. Furthermore, this initial study laid the foundation for a full-scale RCT to examine the impact of RBT+WHC on an array of maternal and neonatal outcomes, within the population of pregnant Coloured as well as Black and White South African women.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Methamphetamine practices

时间窗: 3 months after randomization

Frequency of methamphetamine use in past 30 days measured by RRBA (WHC Revised Risk Behavior Assessment) and urine test

Prenatal care

时间窗: At time of delivery

Number of prenatal care visits measured by chart review of hospital record

Length of hospital stay

时间窗: At time of delivery

Length of hospital stay measured by chart review of hospital record

次要结局

  • Alcohol use(3 months after randomization)
  • Sexual practices(3 months after randomization)
  • Drug and alcohol use composite scores(3 months after randomization)
  • Drug Use(3 months after randomization)
  • Birthweight(At time of delivery)
  • Estimated gestational age(At time of delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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