HIV/STI Prevention for Drug-Involved Couples (Connect II)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Sexually Transmitted Diseases |
Behavioral: Couple HIV/STI prevention intervention Behavioral: Couple-based HIV prevention Behavioral: Individual HIV/STI prevention Behavioral: Couple Wellness Promotion |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | HIV/STI Prevention for Drug-Involved Couples |
- number of unprotected acts of intercourse [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea, and Trichomoniasis [ Time Frame: past 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 564 |
| Study Start Date: | November 2005 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Couple-based HIV prevention | Behavioral: Couple HIV/STI prevention intervention Behavioral: Couple-based HIV prevention |
| Active Comparator: Individual HIV/STI Prevention | Behavioral: Individual HIV/STI prevention |
| Active Comparator: Couple Wellness Promotion | Behavioral: Couple Wellness Promotion |
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| United States, New York | |
| Social Intervention Group/Columbia University School of Social Work | |
| New York, New York, United States, 10027 | |
| Principal Investigator: | Louisa Gilbert, PhD | Columbia University |
More Information
No publications provided
| Responsible Party: | Louisa Gilbert, Social Intervention Group at Columbia University |
| ClinicalTrials.gov Identifier: | NCT01285349 History of Changes |
| Other Study ID Numbers: | AAAA6653 |
| Study First Received: | January 21, 2011 |
| Last Updated: | January 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
|
HIV, STI, condom use, drug use, |
Additional relevant MeSH terms:
|
Sexually Transmitted Diseases Infection Virus Diseases Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 23, 2013