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NCT01285349 · ClinicalTrials.gov registry record · NA
HIV/STI Prevention for Drug-Involved Couples
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 564
- Enrollment target
NCT01285349 is a NA study that has completed, run by Columbia University. The registered enrollment target is 564 participants.
The verdict
NCT01285349, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 564 participants
- Enrollment target
Study Summary
This randomized controlled trial is designed to address gaps in couple-based HIV prevention research by focusing exclusively on HIV negative concordant couples where one or both partners are drug-involved. Building on prior couple-based HIV research that resulted in an evidence-based HIV prevention model for couples (Connect), intervention components were modified to address dyadic drug risk reduction and drug-related unsafe sex and a couple-based HIV risk reduction intervention (Connect II) was designed specifically for drug-involved, HIV negative concordant heterosexual couples at risk for HIV/STIs. For this RCT, couples are recruited primarily through street outreach in drug using locations and randomized into one of three arms: (1) couple-based HIV Risk Reduction condition; (2) individual-based HIV Risk Reduction, which delivered the same content as the couple-based condition but was provided to either the male or female drug-using partner alone; or (3) couple-based Wellness Promotion, which served as an attentional control arm. This RCT tests two major hypotheses: (1) whether the HIV risk reduction intervention provided to the couple or an individual partner would be more efficacious in decreasing number of unprotected acts of intercourse and having a lower cumulative incidence of biologically confirmed STIs over the 12-month follow-up period compared to the Wellness promotion control arm and (2) whether the couple-based HIV risk reduction intervention would be more likely to decrease the number of unprotected acts and have a lower cumulative STI incidence compared to the Individual HIV Risk reduction Arm.
Interventions
- BEHAVIORAL Couple HIV/STI prevention intervention
- BEHAVIORAL Couple-based HIV/STI prevention
- BEHAVIORAL Individual HIV/STI prevention
- BEHAVIORAL Couple Wellness Promotion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 564 participants |
| Start Date | 2005-11 |
| Est. Completion | 2012-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01285349
The ClinicalTrials.gov registry entry for NCT01285349 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 564 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Couple HIV/STI prevention intervention is the first listed.
NCT01285349 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01285349 about?
NCT01285349 is a clinical study titled "HIV/STI Prevention for Drug-Involved Couples". This randomized controlled trial is designed to address gaps in couple-based HIV prevention research by focusing exclusively on HIV negative concordant couples where one or both partners are drug-involved. Building on prior couple-based HIV research that resulted in an evidence-based HIV prevention ...
What is the current status of trial NCT01285349?
This trial is currently completed. It is a NA study. The enrollment target is 564 participants. The study started on 2005-11. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01285349?
The interventions under investigation include: Couple HIV/STI prevention intervention (BEHAVIORAL), Couple-based HIV/STI prevention (BEHAVIORAL), Individual HIV/STI prevention (BEHAVIORAL), Couple Wellness Promotion (BEHAVIORAL).
Who is sponsoring clinical trial NCT01285349?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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