Pregnant Women's CoOp

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
RTI International
ClinicalTrials.gov Identifier:
NCT00722670
First received: July 23, 2008
Last updated: May 7, 2013
Last verified: May 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ 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

  Hide Detailed Description

Detailed Description:

We iteratively adapted and modified the NC woman-focused intervention (Women's CoOp), including the field manual and instrumentation, to focus on pregnant African-American women who abused crack, were currently in substance abuse treatment, and were at risk for HIV or were HIV positive. We then tested 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 were 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.

3. Estimated Enrollment: Can this be changed to 59 (the final enrollment)? Also, is there a way to change "Estimated" to "Final" or something more definite? 4. Study Start Date: Can this be changed to May 2007? 5. Study Completion: February 2009 (I know this date differs from the date in the email I sent earlier when I responded to your questions. Sorry, but this is the correct date to use) 6. Detailed Description: Can the current text be replaced with the following?

APPROACH: During Stage 1A, the team conducted a series of separate focus groups with an expert panel (including researchers, clinicians, and service providers); our Community Advisory Board; HIV+, substance-using, postpartum women; and HIV-, substance-using, postpartum women. We first inquired about how we could adapt the existing measures in the instrumentation, adapt the intervention to address issues of substance-using women who were pregnant, and determine the fidelity of its delivery. After this first set of focus groups, the Woman-Focused manual, measures, and intervention were revised to reflect new adaptations. Then the second set of focus groups with the same members were conducted for review of these materials and fidelity measures. Feedback was solicited to verify our adaptations and then it was pretested to further refine and finalize the manual and measures.

During Stage 1B, we recruited 59 women from treatment facilities in North Carolina. We marketed the study through a brochure as women entered the treatment programs. We also utilized existing outreach efforts for substance abusers at risk for HIV. Women who were eligible and consented to participate in the study gave a urine sample to assess drug use and take part in a 1½ hour ACASI interview. Topics included demographics, drug use, substance abuse treatment, physical health, sexual behavior, mental health, employment history, and criminal history. Once they completed the interview, the women were randomly assigned to either the women's intervention condition or a treatment as usual condition. Once randomized, women in the woman-focused intervention were asked to complete four one-hour intervention sessions within a month that included a personalized assessment and a personal action plan. As part of the second session, woman-focused intervention participants were offered HIV testing. Women in the TAU condition received the traditional substance abuse treatment services. Women in both groups were also assessed at 3-month and 6-month follow-up. Measures included behavioral outcomes, satisfaction with the intervention, and services received.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722670

Locations
United States, North Carolina
RTI International
RTP, North Carolina, United States, 27709
Sponsors and Collaborators
RTI International
Investigators
Principal Investigator: Wendee M Wechsberg, PhD RTI International
  More Information

Publications:
Responsible Party: 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 7, 2013
Health Authority: United States: Federal Government

Keywords provided by RTI International:
risk reduction
prevention
HIV prevention

ClinicalTrials.gov processed this record on August 19, 2014