Treating South African Pregnant Women for Methamphetamine
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Purpose
The purpose of this study is 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 |
- 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
- 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
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2011 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: RBT+WHIC
Participants will meet in groups for 2 hours thrice weekly (M/W/F). During the first hour, the counselor will facilitate 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 will serve the purpose of mutual support during the second hour. The counselor will facilitate but not direct discussion in these latter groups. The 4 WHC modules will be incorporated into the RBT sessions.
|
Behavioral: Experimental
Receive RBT education and a pro-active counseling method
|
|
Active Comparator: Psycho-education
Participants will meet in groups for 2 hours thrice weekly (M/W/F). During the first hour, the counselor will facilitate 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 will serve the purpose of mutual support during the second hour. The counselor will facilitate but not 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. Ongoing study data (N=631 on 10/18/10; planned N=720) indicates that the WHC has had limited success in reducing the use of this among women. Alarmingly, among WHC participants, a greater proportion of pregnant than nonpregnant women reported using meth (n=24/26=92% v. 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 is 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.
Thus, the study will proceed by meeting two sequential aims: Aim 1. Adapt and pretest (N=20) a comprehensive drug abuse treatment model, RBT, into which will be integrated the evidence-based WHC HIV prevention model, in order 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 (N=40) 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.
The public health impact of this proposed project is far-reaching. RBT+WHC will 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, our initial study will lay 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. Finally, this study holds the promise of helping to improve the health of two generations of South Africans, meth-using women and their children.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| South Africa | |
| Medical Research Council | |
| Tygerberg, Western Cape, South Africa, 7505 | |
| Principal Investigator: | Hendree Jones, PhD | RTI International |
More Information
Publications:
| Responsible Party: | RTI International |
| ClinicalTrials.gov Identifier: | NCT01386138 History of Changes |
| Other Study ID Numbers: | DA030565 |
| Study First Received: | June 29, 2011 |
| Last Updated: | January 17, 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:
|
Substance-Related Disorders Behavior, Addictive Mental Disorders Compulsive Behavior Impulsive Behavior Methamphetamine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013