Working... Menu

HIV/STI Prevention for Drug-Involved Couples (ConnectII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285349
Recruitment Status : Completed
First Posted : January 28, 2011
Results First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Information provided by (Responsible Party):
Louisa Gilbert, Columbia University

Brief 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.

Condition or disease Intervention/treatment Phase
Sexually Transmitted Infections Behavioral: Couple HIV/STI prevention intervention Behavioral: Couple-based HIV/STI prevention Behavioral: Individual HIV/STI prevention Behavioral: Couple Wellness Promotion Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV/STI Prevention for Drug-Involved Couples
Study Start Date : November 2005
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Couple-based HIV prevention
7-session couple-based HIV/STI risk reduction intervention (CSTI)
Behavioral: Couple HIV/STI prevention intervention
Behavioral: Couple-based HIV/STI prevention
Active Comparator: Individual HIV/STI Prevention
7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI.
Behavioral: Individual HIV/STI prevention
Placebo Comparator: Couple Wellness Promotion
7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition.
Behavioral: Couple Wellness Promotion

Primary Outcome Measures :
  1. Number of Unprotected Acts of Intercourse [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Number of Participants With Biologically Confirmed STIs (i.e., Chlamydia, Gonorrhea, and Trichomoniasis) [ Time Frame: past 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01285349

Layout table for location information
United States, New York
Social Intervention Group/Columbia University School of Social Work
New York, New York, United States, 10027
Sponsors and Collaborators
Columbia University
Layout table for investigator information
Principal Investigator: Louisa Gilbert, PhD Columbia University

Publications of Results:
Layout table for additonal information
Responsible Party: Louisa Gilbert, Associate Research Scientist in the Faculty of Social Work , Adjunct Assistant Professor of Social Work, Columbia University Identifier: NCT01285349     History of Changes
Other Study ID Numbers: AAAA6653
First Posted: January 28, 2011    Key Record Dates
Results First Posted: January 14, 2019
Last Update Posted: January 14, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from this study is currently available for public use. Requests to use data should be made to the PI, Louisa Gilbert (
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data is currently available.
Access Criteria: Please contact PI for sharing access. Data are available for public use.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Louisa Gilbert, Columbia University:
HIV, STI, condom use, drug use,

Additional relevant MeSH terms:
Layout table for MeSH terms
Sexually Transmitted Diseases
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female