Treating South African Pregnant Women for Methamphetamine

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.

Study Overview

• Status: Completed
• Conditions: HIV; Drug Addiction
• Intervention / Treatment: Behavioral: Experimental; Behavioral: Psycho-education

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Tygerberg, Western Cape, South Africa, 7505
      • Medical Research Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RBT+WHIC; Participants met in groups for 2 hours thrice weekly (M/W/F). During the first hour, the counselor facilitated discussion of 1 of the 12 RBT module topics, repeated three times during the course of the 12-week intervention (as in RBT). A patient-led group served the purpose of mutual support during the second hour. The counselor facilitated but did not have direct discussion in these latter groups. The four WHC modules were incorporated into the RBT sessions.	Behavioral: Experimental; Receive RBT education and a pro-active counseling method
Active Comparator: Psycho-education; Participants met in groups for 2 hours thrice weekly (M/W/F). During the first hour, the counselor facilitated discussion of 1 of the 12 RBT module topics, repeated three times during the course of the 12-week intervention (as in RBT). A patient-led group served the purpose of mutual support during the second hour. The counselor facilitated but did not have direct discussion in these latter groups.	Behavioral: Psycho-education; Receive RBT education and peer-support in a group format.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Methamphetamine practices	Frequency of methamphetamine use in past 30 days measured by RRBA (WHC Revised Risk Behavior Assessment) and urine test	3 months after randomization
Prenatal care	Number of prenatal care visits measured by chart review of hospital record	At time of delivery
Length of hospital stay	Length of hospital stay measured by chart review of hospital record	At time of delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Use	Frequency of opioid, cocaine, mandrax, marijuana, and self-report nicotine use in past 30 days measured by RRBA (WHC Revised Risk Behavior Assessment) and urine test	3 months after randomization
Drug and alcohol use composite scores	Drug and alcohol composite scores measured by the Addiction Severity Index	3 months after randomization
Alcohol use	Frequency of alcohol use in past 30 days measured by RRBA and breath test	3 months after randomization
Sexual practices	Frequency of unprotected sexual acts at last sexual encounter and in past 30 days measured by RRBA	3 months after randomization
Birthweight	Birthweight measured by chart review of hospital record	At time of delivery
Estimated gestational age	Estimated gestational age measured by chart review of hospital record	At time of delivery

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: University of Cape Town
• Investigators: Principal Investigator: Felicia Browne, ScD, RTI International

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimated): June 30, 2011

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: HIV; Women; Pregnancy; Alcohol; Cocaine; Nicotine; Opioids; Marijuana; Stimulants; Methamphetamine; Drug Treatment; Sexually Transmitted Infections; Drug Use; Neonatal Health; HIV Risk; Gender-specific Treatment; Injection Drugs; Mandrax
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: DA030565