HIVNCT01386138
Treating South African Pregnant Women for Methamphetamine
A study testing Psycho-education and Experimental in people with HIV and Drug Addiction, run by RTI International at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Drug Addiction
- What is being tested?
- Psycho-education and Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jul 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- are HIV negative
- provide verifiable locator information for follow-up interview
- are 20-28 weeks pregnant, inclusive, and determined by last menstrual period
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Medical Research Council
Tygerberg, Western Cape, 7505
About this study
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.
Read the 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.
- Conditions
- HIV, Drug Addiction
- Being tested
- Psycho-education, Experimental
- 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
- Medical subject headings
- Substance-Related Disorders, Sexually Transmitted Diseases, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-educationBehavioural
Receive RBT education and peer-support in a group format.
ExperimentalBehavioural
Receive RBT education and a pro-active counseling method
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psycho-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methamphetamine practices
Frequency of methamphetamine use in past 30 days measured by RRBA (WHC Revised Risk Behavior Assessment) and urine test
Measured: 3 months after randomization
Prenatal care
Number of prenatal care visits measured by chart review of hospital record
Measured: At time of delivery
Length of hospital stay
Length of hospital stay measured by chart review of hospital record
Measured: At time of delivery
Secondary outcomes (6)
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
Measured: 3 months after randomization
Drug and alcohol use composite scores
Drug and alcohol composite scores measured by the Addiction Severity Index
Measured: 3 months after randomization
Alcohol use
Frequency of alcohol use in past 30 days measured by RRBA and breath test
Measured: 3 months after randomization
Sexual practices
Frequency of unprotected sexual acts at last sexual encounter and in past 30 days measured by RRBA
Measured: 3 months after randomization
Birthweight
Birthweight measured by chart review of hospital record
Measured: At time of delivery
Estimated gestational age
Estimated gestational age measured by chart review of hospital record
Measured: At time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Sponsor
- Investigators
- Felicia Browne, ScD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386138
- Sponsor's protocol ID
- DA030565
- Status last verified
- Jan 2025
- First submitted
- 29 Jun 2011
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating South African Pregnant Women for Methamphetamine
- ClinicalTrials.gov ID
- NCT01386138
- Acronym / sponsor ID
- DA030565
- Conditions
- HIV, Drug Addiction
- Keywords
- HIV, HIV Risk, Sexually Transmitted Infections, Women, Pregnancy, Neonatal Health, Drug Use, Drug Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBT+WHIC | Experimental | Behavioral: ExperimentalParticipants 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. |
| Psycho-education | Active comparator | Behavioral: Psycho-educationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-educationReceive RBT education and peer-support in a group format. | Behavioural | Psycho-education |
| ExperimentalReceive RBT education and a pro-active counseling method | Behavioural | RBT+WHIC |
Primary outcome
Methamphetamine practices
Time frame: 3 months after randomization
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
Number of prenatal care visits measured by chart review of hospital record
Length of hospital stay
Time frame: At time of delivery
Length of hospital stay measured by chart review of hospital record
6 secondary outcomes
Drug Use
Time frame: 3 months after randomization
Drug and alcohol use composite scores
Time frame: 3 months after randomization
Alcohol use
Time frame: 3 months after randomization
Sexual practices
Time frame: 3 months after randomization
Birthweight
Time frame: At time of delivery
Estimated gestational age
Time frame: At time of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felicia Browne, ScD principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-education and Experimental in people with HIV and Drug Addiction, run by RTI International at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methamphetamine practices (time frame: 3 months after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.