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Pregnant Women's CoOp

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722670
First Posted: July 25, 2008
Last Update Posted: May 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
RTI International
  Purpose

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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Woman-Focused HIV Prevention With Pregnant African-Americans

Resource links provided by NLM:


Further study details as provided by RTI International:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To explore the intervention's potential mechanisms of action and moderating factors that may influence response to the treatment. [ Time Frame: at 6 months ]

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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, North Carolina
RTI International
RTP, North Carolina, United States, 27709
Sponsors and Collaborators
RTI International
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Wendee M Wechsberg, PhD RTI International