Connect 'n Unite: Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM (CNU)

This study is currently recruiting participants.
Verified May 2013 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elwin Wu, Columbia University
ClinicalTrials.gov Identifier:
NCT01394900
First received: July 13, 2011
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

This study rigorously tests the efficacy of a couples-based HIV and sexually transmitted infection (HIV/STI) preventive intervention for African American/Black men who have sex with men (MSM) in same sex intimate relationships in which at least one partner is using stimulants (herein referred to as "stimulant-using, Black MSM couples"). This study is a logical progression from the investigative team's CDC-funded pilot study that successfully pilot tested a couples-based intervention originally for heterosexual couples ("Connect") adapted for a new target population of methamphetamine-using, Black MSM couples. That pilot study culminated with a manualized, 7-session intervention entitled "Connect 'n Unite" (CNU—pronounced "seein' you"—for short) as a candidate couples-based HIV preventive intervention for stimulant-using, Black MSM couples. This study is a randomized clinical trial with 240 stimulant-using, Black MSM couples to test the impact of CNU versus a wellness promotion (WP) attention control condition on behavioral and biologically assayed outcomes over a 12-month follow-up period. The study has the following primary aims: (1) to test whether participants assigned to CNU engage in lower HIV/STI behavioral risk compared to participants assigned to WP; (2) to test whether participants assigned to CNU have lower cumulative incidence of STIs—chlamydia and gonorrhea—confirmed via biological assay compared to participants assigned to WP; and (3) to test whether participants assigned to CNU engage in less drug use compared to participants assigned to WP.


Condition Intervention
HIV
Sexually Transmitted Infections
Behavioral: Connect 'n Unite
Behavioral: Wellness Promotion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Sexually transmitted infection (STI) incidence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Cumulative incidence of chlamydia and gonorrhea detected by biological assay

  • Sexual HIV risk behavior [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of acts of unprotected anal intercourse; Proportion of acts of anal intercourse that are condom-protected; Number of sexual partners

  • Illicit drug use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency of illicit drug use (self-reported); Number of types of illicit drugs used (self-reported)


Estimated Enrollment: 480
Study Start Date: July 2012
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Connect 'n Unite
7-session, manualized intervention
Behavioral: Connect 'n Unite
Couple-based behavioral HIV/STI preventive intervention
Active Comparator: Wellness Program
7-session intervention that will an attention control condition
Behavioral: Wellness Promotion
Couple-based behavioral intervention to promote general health-promoting activities (e.g., exercise, nutrition, disease screening, stress reduction)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • At least 18 years old
  • Report having a "primary/main male partner" operationalized as a male with whom he has had an ongoing sexual relationship over the prior 6 months and has an emotional bond with more than any person
  • Self-identify as African American and/or Black, or identify having a main partner who self-identifies in this manner
  • Report using a stimulant—operationally defined as cocaine, crack, or a methamphetamine-group substance—in the past 90 days (or has a main male partner who meets this criterion)
  • Report having unprotected anal sex with a man who is a non-main partner in the past 90 days (or has a main male partner who meets this criterion)
  • Identify each other as their main partner

Exclusion Criteria:

  • Either partner reports the occurrence of ≥1 incident of severe intimate partner violence (IPV) within the relationship in the past year as assessed using the Revised Conflict Tactics Scales
  • Either partner has a language or cognitive impairment that prevents comprehension of study procedures as assessed during informed consent
  • Either partner reports being currently involved (i.e., has not completed the final follow-up assessment) in an HIV prevention research study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394900

Contacts
Contact: Elwin Wu, PhD 212.851.2397 ew157@columbia.edu

Locations
United States, New York
Columbia University School of Social Work Recruiting
New York, New York, United States, 10027
Contact: Elwin Wu, PhD       ew157@columbia.edu   
Principal Investigator: Elwin Wu, PhD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Elwin Wu, PhD Columbia University
  More Information

No publications provided

Responsible Party: Elwin Wu, Associate Professor of Social Work, Columbia University
ClinicalTrials.gov Identifier: NCT01394900     History of Changes
Other Study ID Numbers: AAAI5452, 1R01DA030296-01A1
Study First Received: July 13, 2011
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
HIV
sexually transmitted infection
STI
men who have sex with men
MSM
couples
African American
Black

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014