HIV/STI Prevention for Drug-Involved Couples

NCT01285349 | Completed Results

• 1 other identifier: AAAA6653
• Study Type: interventional
• Target: 564
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexually Transmitted Infections

Keywords

HIV, STI, condom use, drug use,

Outcome Measures

Primary Outcomes (1)

• Number of Unprotected Acts of Intercourse

  90 days

Secondary Outcomes (1)

• Number of Participants With Biologically Confirmed STIs (i.e., Chlamydia, Gonorrhea, and Trichomoniasis)

  past 12 months

Study Arms (3)

Couple-based HIV prevention

EXPERIMENTAL

7-session couple-based HIV/STI risk reduction intervention (CSTI)

Behavioral: Couple HIV/STI prevention intervention; Behavioral: Couple-based HIV/STI prevention

Individual HIV/STI Prevention

ACTIVE COMPARATOR

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

Couple Wellness Promotion

PLACEBO COMPARATOR

7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition.

Behavioral: Couple Wellness Promotion

Interventions

Couple HIV/STI prevention intervention BEHAVIORAL

Couple-based HIV prevention

Couple-based HIV/STI prevention BEHAVIORAL

Couple-based HIV prevention

Individual HIV/STI prevention BEHAVIORAL

Individual HIV/STI Prevention

Couple Wellness Promotion BEHAVIORAL

Couple Wellness Promotion

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Social Intervention Group/Columbia University School of Social Work

New York, New York, 10027, United States

Location

Related Publications (1)

• El-Bassel N, Gilbert L, Wu E, Witte SS, Chang M, Hill J, Remien RH. Couple-based HIV prevention for low-income drug users from New York City: a randomized controlled trial to reduce dual risks. J Acquir Immune Defic Syndr. 2011 Oct 1;58(2):198-206. doi: 10.1097/QAI.0b013e318229eab1.

  PMID: 21725249 RESULT

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Nabila El-Bassel
• Organization: Social Intervention Group

ne5@columbia.edu

212-851-2391

Study Officials

• Louisa Gilbert, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist in the Faculty of Social Work , Adjunct Assistant Professor of Social Work

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 28, 2011
• Study Start: November 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2012
• Last Updated: January 14, 2019
• Results First Posted: January 14, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data is currently available.
• Access Criteria: Please contact PI for sharing access. Data are available for public use.

Locations

US (1)