Clinical trial NCT01386138: Treating South African Pregnant Women for Methamphetamine
Official title: Treating South African Pregnant Women for Methamphetamine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Drug Addiction
Keywords: HIV
HIV Risk
Sexually Transmitted Infections
Women
Pregnancy
Neonatal Health
Drug Use
Drug Treatment
Gender-specific Treatment
Methamphetamine
Opioids
Cocaine
Injection Drugs
Stimulants
Alcohol
Mandrax
Marijuana
Nicotine
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: University of Cape Town
First posted: 2011-06-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Methamphetamine practices
timeFrame: 3 months after randomization
measure: Prenatal care
timeFrame: At time of delivery
measure: Length of hospital stay
timeFrame: At time of delivery
Secondary outcomes:
measure: Drug Use
timeFrame: 3 months after randomization
measure: Drug and alcohol use composite scores
timeFrame: 3 months after randomization
measure: Alcohol use
timeFrame: 3 months after randomization
measure: Sexual practices
timeFrame: 3 months after randomization
measure: Birthweight
timeFrame: At time of delivery
measure: Estimated gestational age
timeFrame: At time of delivery
Other outcomes:
Locations:
city: Tygerberg
country: South Africa
facility: Medical Research Council
state: Western Cape
Study officials:
affiliation: RTI International
name: Felicia Browne, ScD
role: PRINCIPAL_INVESTIGATOR
References: