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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: Completed NA study, sponsored by Columbia University.

NCT01285349 is a NA study that has completed, run by Columbia University. The registered enrollment target is 564 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 564 participants
Start Date 2005-11
Est. Completion 2012-11
Phase NA
Columbia University

958 total trials

What the finished NCT01285349 record still lists

NCT01285349 is an interventional study that assigns participants to a tested intervention. The registered 564 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 4 interventions - of which Couple HIV/STI prevention intervention is the first listed.

NCT01285349 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01285349's enrollment target sits among peer trials

564 180th of 2000 higher than 1,820 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01285349, the US trial registry maintained by the National Library of Medicine. NCT01285349 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.