Pregnant Women's CoOp
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|ClinicalTrials.gov Identifier: NCT00722670|
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : May 9, 2013
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 or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Woman-focused intervention Behavioral: Treatment as Usual||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Woman-Focused HIV Prevention With Pregnant African-Americans|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||August 2010|
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
- 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 ]
- To explore the intervention's potential mechanisms of action and moderating factors that may influence response to the treatment. [ Time Frame: at 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722670
|United States, North Carolina|
|RTP, North Carolina, United States, 27709|
|Principal Investigator:||Wendee M Wechsberg, PhD||RTI International|