Pregnant Women's CoOp

NCT00722670 | Completed Phase 1

• 1 other identifier: R01DA020852
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

risk reduction; prevention; HIV prevention

Outcome Measures

Primary Outcomes (1)

• 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).

  3- and 6-month follow-up

Secondary Outcomes (1)

• To explore the intervention's potential mechanisms of action and moderating factors that may influence response to the treatment.

  at 6 months

Study Arms (2)

Woman-focused (WF)

EXPERIMENTAL

Woman-focused intervention (Women's CoOp)

Behavioral: Woman-focused intervention

Treatment as Usual (TAU)

ACTIVE COMPARATOR

TAU (substance abuse treatment only)

Behavioral: Treatment as Usual

Interventions

Woman-focused intervention BEHAVIORAL

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

Woman-focused (WF)

Treatment as Usual BEHAVIORAL

Participants in this group only received services that were part of their substance abuse treatment program

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

Sponsors & Collaborators

• RTI International: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

RTI International

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (3)

• Wechsberg WM, Browne FA, Ellerson RM, Zule WA. Adapting the evidence-based Women's CoOp intervention to prevent human immunodeficiency virus infection in North Carolina and international settings. N C Med J. 2010 Sep-Oct;71(5):477-81. No abstract available.

  PMID: 21473554 BACKGROUND

• Wechsberg WM, Browne FA, Poulton W, Ellerson RM, Simons-Rudolph A, Haller D. Adapting an evidence-based HIV prevention intervention for pregnant African-American women in substance abuse treatment. Subst Abuse Rehabil. 2011 Feb 10;2:35-42. doi: 10.2147/SAR.S16370. eCollection 2011.

  PMID: 24474853 BACKGROUND

• Jones HE, Berkman ND, Kline TL, Ellerson RM, Browne FA, Poulton W, Wechsberg WM. Initial feasibility of a woman-focused intervention for pregnant african-american women. Int J Pediatr. 2011;2011:389285. doi: 10.1155/2011/389285. Epub 2011 Mar 23.

  PMID: 21541069 BACKGROUND

MeSH Terms

Conditions

Risk Reduction Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Felicia Browne, ScD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Social Epidemiologist

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 25, 2008
• Study Start: June 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: August 1, 2010
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

US (1)