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N/A N=564 Randomized Quadruple-blind Prevention

HIV/STI Prevention for Drug-Involved Couples

Sexually Transmitted Infections

Enrolled (actual)
564
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Number of Unprotected Acts of Intercourse — 19.7; 12.9; 18.2 # of unprotected sex acts at 12 months

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Couple HIV/STI prevention intervention (Behavioral); Couple-based HIV/STI prevention (Behavioral); Individual HIV/STI prevention (Behavioral); Couple Wellness Promotion (Behavioral)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Columbia University
Primary completion
Oct 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Unprotected Acts of Intercourse
19.7; 12.9; 18.2
SECONDARY
Number of Participants With Biologically Confirmed STIs (i.e., Chlamydia, Gonorrhea, and Trichomoniasis)
3; 3; 2

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01285349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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