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
  Purpose

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.


Condition Intervention
HIV
Drug Addiction
Behavioral: Psycho-education
Behavioral: Experimental

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Treating South African Pregnant Women for Methamphetamine

Resource links provided by NLM:


Further study details as provided by RTI International:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: July 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386138

Locations
South Africa
Medical Research Council
Tygerberg, Western Cape, South Africa, 7505
Sponsors and Collaborators
RTI International
University of Cape Town
Investigators
Principal Investigator: Wendee Wechsberg, PhD RTI International
  More Information

No publications provided

Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT01386138     History of Changes
Other Study ID Numbers: DA030565
Study First Received: June 29, 2011
Last Updated: October 16, 2013
Health Authority: South Africa: Medicines Control Council

Keywords provided by RTI International:
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

Additional relevant MeSH terms:
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014