Treating South African Pregnant Women for Methamphetamine

NCT01386138 | Completed DMC

• 1 other identifier: DA030565
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Drug Use

  3 months after randomization

• Drug and alcohol use composite scores

  3 months after randomization

• Alcohol use

  3 months after randomization

• Sexual practices

  3 months after randomization

• Birthweight

  At time of delivery

Study Arms (2)

RBT+WHIC

EXPERIMENTAL

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

Psycho-education

ACTIVE COMPARATOR

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

Interventions

Psycho-education BEHAVIORAL

Receive RBT education and peer-support in a group format.

Psycho-education

Experimental BEHAVIORAL

Receive RBT education and a pro-active counseling method

RBT+WHIC

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RTI International: lead
• University of Cape Town: collaborator

Study Sites (1)

Medical Research Council

Tygerberg, Western Cape, 7505, South Africa

Location

MeSH Terms

Conditions

Substance-Related Disorders; Sexually Transmitted Diseases; Marijuana Abuse

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Felicia Browne, ScD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: June 30, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

ZA (1)