HIV/STI Prevention for Drug-Involved Couples

Completed · Not applicable

Conditions studied: Sexually Transmitted Infections

In brief

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.

Key facts

Study ID

NCT01285349

Run by

Columbia University

People needed

564

Starts

2005-11-01

Expected to finish

2012-11-01

Last updated by the study team

2019-01-14

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Couples were eligible to participate if:
• Both were 18 and older and at least one partner was 18-40
• Both tested HIV negative using Oratest procedures
• Both identified each other as main, regular partner, boy/girlfriend, spouse, lover
• Both reported that they have been together for at least 6 months
• Both intended to remain together for at least one year
• At least one partner reported using illicit drugs in the prior 90 days and was seeking or in drug treatment
• At least one partner reported having had unprotected intercourse with the other in the prior 90 days.
• Additionally, at least one partner had to report one or more of the following HIV risk criteria:
• Having had sex with other partners in the prior 90 days
• Injecting drugs in the prior 90 days; or
• Self-report being diagnosed with an STI in the prior 90 days.

You may not qualify if…

• Couples were excluded from the study:
• If either partner reported experiencing severe intimate partner violence in the past year by the other partner as assessed by subscales of the Revised Conflict Tactics Scale
• If either partner exhibited a severe cognitive or psychiatric impairment assessed during informed consent
• If either partner did not have sufficient understanding of English
• If either partner reported intentions to have a baby in the next year and to relocate beyond a reasonable distance from the study site in the coming year.

Where it is running

• Social Intervention Group/Columbia University School of Social Work — New York, New York, United States

Full record on ClinicalTrials.gov

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