search
Back to results

Treating South African Pregnant Women for Methamphetamine

Primary Purpose

HIV, Drug Addiction

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Psycho-education
Experimental
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Research Council

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RBT+WHIC

Psycho-education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Methamphetamine practices
Frequency of methamphetamine use in past 30 days measured by RRBA (WHC Revised Risk Behavior Assessment) and urine test
Prenatal care
Number of prenatal care visits measured by chart review of hospital record
Length of hospital stay
Length of hospital stay measured by chart review of hospital record

Secondary Outcome Measures

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
Drug and alcohol use composite scores
Drug and alcohol composite scores measured by the Addiction Severity Index
Alcohol use
Frequency of alcohol use in past 30 days measured by RRBA and breath test
Sexual practices
Frequency of unprotected sexual acts at last sexual encounter and in past 30 days measured by RRBA
Birthweight
Birthweight measured by chart review of hospital record
Estimated gestational age
Estimated gestational age measured by chart review of hospital record

Full Information

First Posted
June 29, 2011
Last Updated
October 16, 2013
Sponsor
RTI International
Collaborators
University of Cape Town
search

1. Study Identification

Unique Protocol Identification Number
NCT01386138
Brief Title
Treating South African Pregnant Women for Methamphetamine
Official Title
Treating South African Pregnant Women for Methamphetamine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI International
Collaborators
University of Cape Town

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RBT+WHIC
Arm Type
Experimental
Arm Description
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.
Arm Title
Psycho-education
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Psycho-education
Intervention Description
Receive RBT education and peer-support in a group format.
Intervention Type
Behavioral
Intervention Name(s)
Experimental
Intervention Description
Receive RBT education and a pro-active counseling method
Primary Outcome Measure Information:
Title
Methamphetamine practices
Description
Frequency of methamphetamine use in past 30 days measured by RRBA (WHC Revised Risk Behavior Assessment) and urine test
Time Frame
3 months after randomization
Title
Prenatal care
Description
Number of prenatal care visits measured by chart review of hospital record
Time Frame
At time of delivery
Title
Length of hospital stay
Description
Length of hospital stay measured by chart review of hospital record
Time Frame
At time of delivery
Secondary Outcome Measure Information:
Title
Drug Use
Description
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
Time Frame
3 months after randomization
Title
Drug and alcohol use composite scores
Description
Drug and alcohol composite scores measured by the Addiction Severity Index
Time Frame
3 months after randomization
Title
Alcohol use
Description
Frequency of alcohol use in past 30 days measured by RRBA and breath test
Time Frame
3 months after randomization
Title
Sexual practices
Description
Frequency of unprotected sexual acts at last sexual encounter and in past 30 days measured by RRBA
Time Frame
3 months after randomization
Title
Birthweight
Description
Birthweight measured by chart review of hospital record
Time Frame
At time of delivery
Title
Estimated gestational age
Description
Estimated gestational age measured by chart review of hospital record
Time Frame
At time of delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendee Wechsberg, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Research Council
City
Tygerberg
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

Treating South African Pregnant Women for Methamphetamine

We'll reach out to this number within 24 hrs