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NCT00722670 · ClinicalTrials.gov registry record · Phase 1
Pregnant Women's CoOp
A Phase 1 study, sponsored by RTI International.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT00722670 is a Phase 1 study that has completed, run by RTI International. The registered enrollment target is 100 participants.
The verdict
NCT00722670, a Phase 1 study, has completed, sponsored by RTI International.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Treatment as Usual
- BEHAVIORAL Woman-focused intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2007-06 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00722670
The ClinicalTrials.gov registry entry for NCT00722670 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RTI International, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Treatment as Usual is the first listed.
NCT00722670 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00722670 about?
NCT00722670 is a clinical study titled "Pregnant Women's CoOp". 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 te...
What is the current status of trial NCT00722670?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2007-06. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00722670?
The interventions under investigation include: Treatment as Usual (BEHAVIORAL), Woman-focused intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT00722670?
This trial is sponsored by RTI International, which has 45 total clinical trials registered on ClinicalTrials.gov.
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