HIV/STI Prevention for Drug-Involved Couples (Connect II)

This study has been completed.
Sponsor:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT01285349
First received: January 21, 2011
Last updated: January 26, 2011
Last verified: January 2011

January 21, 2011
January 26, 2011
November 2005
October 2009   (final data collection date for primary outcome measure)
number of unprotected acts of intercourse [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01285349 on ClinicalTrials.gov Archive Site
cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea, and Trichomoniasis [ Time Frame: past 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
HIV/STI Prevention for Drug-Involved Couples
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 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Sexually Transmitted Diseases
  • Behavioral: Couple HIV/STI prevention intervention
  • Behavioral: Couple-based HIV prevention
  • Behavioral: Individual HIV/STI prevention
  • Behavioral: Couple Wellness Promotion
  • Experimental: Couple-based HIV prevention
    Interventions:
    • Behavioral: Couple HIV/STI prevention intervention
    • Behavioral: Couple-based HIV prevention
  • Active Comparator: Individual HIV/STI Prevention
    Intervention: Behavioral: Individual HIV/STI prevention
  • Active Comparator: Couple Wellness Promotion
    Intervention: Behavioral: Couple Wellness Promotion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
564
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01285349
AAAA6653
No
Louisa Gilbert, Social Intervention Group at Columbia University
Columbia University
Not Provided
Principal Investigator: Louisa Gilbert, PhD Columbia University
Columbia University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP