Pregnant Women's CoOp
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We will iteratively adapt and modify the NC woman-focused intervention (Women's CoOp), including the field manual and instrumentation, to focus on pregnant African-American women who abuse crack, are currently in substance abuse treatment, and are at risk for HIV or are HIV positive. We then will test the newly developed intervention in a Stage IB pilot-sized randomized clinical trial (RCT) in a traditional substance abuse treatment clinic to determine (a) feasibility; (b) relative efficacy compared with substance abuse treatment-as-usual (TAU), across several domains of functioning (e.g., substance use, HIV risk behaviors); and (c) the intervention's potential mechanisms of action.
The specific aims of this Stage IA/B study are as follows:
Aim 1. To adapt the culturally specific, manualized woman-focused intervention to specifically address issues of pregnancy and substance abuse, relationships with men, social support, parenting, HIV status, living with HIV, antiretroviral (ARV) treatment, and HIV risk-reduction methods for pregnant and postpartum women.
Aim 2. To compare the relative efficacy of the woman-focused intervention for pregnant women relative to standard substance abuse treatment to sustain reductions in substance abuse and sexual risk behaviors, maintain retention in drug treatment, reduce violence, and improve prenatal care and ARV treatment adherence (as needed) at 3- and 6-month follow-up.
Aim 3. To explore the intervention's potential mechanisms of action (e.g., by examining the mediating effects of changes in knowledge about HIV risk behaviors, psychological distress, readiness for change) and moderating factors (e.g., HIV status, age, stage of pregnancy, relationships with men) that may influence response to the treatment.
Condition | Intervention | Phase |
---|---|---|
HIV |
Behavioral: Woman-focused intervention Behavioral: Treatment as Usual |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
Official Title: | Woman-Focused HIV Prevention With Pregnant African-Americans |
- To compare the relative efficacy of the woman-focused intervention in reductions in substance abuse and sexual risk behaviors, maintain retention in drug treatment, reduce violence, and improve prenatal care and ARV treatment adherence (as needed). [ Time Frame: 3- and 6-month follow-up ] [ Designated as safety issue: No ]
- To explore the intervention's potential mechanisms of action and moderating factors that may influence response to the treatment. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
Enrollment: | 100 |
Study Start Date: | June 2007 |
Study Completion Date: | August 2010 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Woman-focused (WF)
Woman-focused intervention (Women's CoOp)
|
Behavioral: Woman-focused intervention
Participants in this group received a four individual sessions of the woman-focused intervention, in addition to services that were part of their substance abuse treatment program
|
Active Comparator: Treatment as Usual (TAU)
TAU (substance abuse treatment only)
|
Behavioral: Treatment as Usual
Participants in this group only received services that were part of their substance abuse treatment program
|
![](https://webarchive.library.unt.edu/web/20130315211251im_/http://clinicaltrials.gov/ct2/html/images/frame/plus.gif)
![](https://webarchive.library.unt.edu/web/20130315211251im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female
- 18 years of age or older
- Self-identify as Black/African-American
- Between 14 weeks (3½ months) and 32 weeks (8 months) gestation (pregnancy was confirmed via biological test)
- Self-report the use of an illicit drug within the past 12 months
- Currently enrolled in a substance abuse treatment program for at least 7 days
- Willing to provide written informed consent and verifiable locator information for follow-up assessments
Exclusion Criteria:
• Been in any previous CoOp studies
![](https://webarchive.library.unt.edu/web/20130315211251im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, North Carolina | |
RTI International | |
RTP, North Carolina, United States, 27709 |
Principal Investigator: | Wendee M Wechsberg, PhD | RTI International |
![](https://webarchive.library.unt.edu/web/20130315211251im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
Responsible Party: | Wendee M. Wechsberg, PhD, Principal Investigator, RTI International |
ClinicalTrials.gov Identifier: | NCT00722670 History of Changes |
Other Study ID Numbers: | R01 DA020852, R01DA020852 |
Study First Received: | July 23, 2008 |
Last Updated: | May 2, 2011 |
Health Authority: | United States: Federal Government |
Keywords provided by RTI International:
risk reduction prevention HIV prevention |
ClinicalTrials.gov processed this record on March 14, 2013