Pregnant Women's CoOp
Completed · Phase 1
Conditions studied: HIV
In brief
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.
Key facts
- Study ID
- NCT00722670
- Run by
- RTI International
- People needed
- 100
- Starts
- 2007-06-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2025-06-04
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Been in any previous CoOp studies
Where it is running
- RTI International — Research Triangle Park, North Carolina, United States
Full record on ClinicalTrials.gov
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