Treating South African Pregnant Women for Methamphetamine

This study has been completed.
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
RTI International
ClinicalTrials.gov Identifier:
NCT01386138
First received: June 29, 2011
Last updated: October 16, 2013
Last verified: October 2013

June 29, 2011
October 16, 2013
July 2011
June 2013   (final data collection date for primary outcome measure)
  • Methamphetamine practices [ Time Frame: 3 months after randomization ] [ Designated as safety issue: No ]
    Frequency of methamphetamine use in past 30 days measured by RRBA (WHC Revised Risk Behavior Assessment) and urine test
  • Prenatal care [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
    Number of prenatal care visits measured by chart review of hospital record
  • Length of hospital stay [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
    Length of hospital stay measured by chart review of hospital record
Same as current
Complete list of historical versions of study NCT01386138 on ClinicalTrials.gov Archive Site
  • Drug Use [ Time Frame: 3 months after randomization ] [ Designated as safety issue: No ]
    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
  • Drug and alcohol use composite scores [ Time Frame: 3 months after randomization ] [ Designated as safety issue: No ]
    Drug and alcohol composite scores measured by the Addiction Severity Index
  • Alcohol use [ Time Frame: 3 months after randomization ] [ Designated as safety issue: No ]
    Frequency of alcohol use in past 30 days measured by RRBA and breath test
  • Sexual practices [ Time Frame: 3 months after randomization ] [ Designated as safety issue: No ]
    Frequency of unprotected sexual acts at last sexual encounter and in past 30 days measured by RRBA
  • Birthweight [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
    Birthweight measured by chart review of hospital record
  • Estimated gestational age [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
    Estimated gestational age measured by chart review of hospital record
  • Drug Use [ Time Frame: 3 months after randomization ] [ Designated as safety issue: No ]
    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
  • Drug and alcohol use composite scores [ Time Frame: 3 months after randomization ] [ Designated as safety issue: No ]
    Drug and alcohol composite scores measured by the Addiction Severity Index
  • Alcohol use [ Time Frame: 3 months after randomization ] [ Designated as safety issue: No ]
    Frequency of alcohol use in past 30 days measured by RRBA and breath test
  • Sexual practices [ Time Frame: 3 months after randomization ] [ Designated as safety issue: No ]
    Unprotected sex at last sexual encounter measured by RRBA
  • Birthweight [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
    Birthweight measured by chart review of hospital record
  • Estimated gestational age [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
    Estimated gestational age measured by chart review of hospital record
Not Provided
Not Provided
 
Treating South African Pregnant Women for Methamphetamine
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • HIV
  • Drug Addiction
  • Behavioral: Psycho-education
    Receive RBT education and peer-support in a group format.
  • Behavioral: Experimental
    Receive RBT education and a pro-active counseling method
  • 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.
    Intervention: Behavioral: Experimental
  • 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.
    Intervention: Behavioral: Psycho-education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01386138
DA030565
Yes
RTI International
RTI International
University of Cape Town
Principal Investigator: Wendee Wechsberg, PhD RTI International
RTI International
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP