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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Elwin Wu, Columbia University
ClinicalTrials.gov Identifier:
NCT01394900
First received: July 13, 2011
Last updated: February 9, 2016
Last verified: February 2016
  Purpose
The study has the following primary aims: (1) to test whether participants assigned to CNU (a 7-session, manualized intervention entitled "Connect 'n Unite") engage in lower HIV/STI behavioral risk compared to participants assigned to WP (a wellness promotion attention control condition); (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: CNU Intervention
Behavioral: WP Intervention

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:
  • Difference in number of unprotected acts of anal intercourse between 2 groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To test whether participants assigned to the CNU intervention engage in lower HIV/STI behavioral risk compared to participants assigned to the WP attention control condition using the following primary outcome - number of unprotected acts of anal intercourse.


Secondary Outcome Measures:
  • Difference in incidence of sexually transmitted infections (STIs) between 2 groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To test whether participants assigned to CNU have lower cumulative incidence of STIs confirmed via biological assay compared to participants assigned to WP.

  • Difference in number of illicit drug use between 2 groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To test whether participants assigned to CNU engage in less drug use compared to participants assigned to WP.


Enrollment: 424
Study Start Date: July 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CNU intervention
African American/Black men who have sex with men (MSM) in same sex intimate relationships in which at least one partner is illicitly using psychostimulants and/or psychoactive substances will receive 4 sessions of CNU intervention
Behavioral: CNU Intervention
Notions that strengthen the closeness with one's partner, connect with similar couples, and visibly strengthen a community as key to combating dynamics that cause poor communication, isolation, fragmentation of the Black MSM community.
Other Name: Connect 'n Unite (CNU) Intervention
Active Comparator: WP intervention
African American/Black men who have sex with men (MSM) in same sex intimate relationships in which at least one partner is illicitly using psychostimulants and/or psychoactive substances will receive 4 sessions of general wellness promotion (WP) intervention
Behavioral: WP Intervention
Attention control condition - WP focuses on nutrition, fitness, healthcare, and stress management. Given the prevalence of health problems among the target population, WP emphasizes adherence to medical guidance and medication regimens.
Other Name: Wellness Promotion (WP) Intervention

Detailed Description:
This study addresses the overrepresentation of the African American/Black community among those living with HIV/AIDS in the U.S. as well as men who have sex with men (MSM), the transmission category that accounts for the majority of HIV infections. In the absence of a vaccine or cure for HIV infection, behavioral risk reduction represents the best public health tool for prevention of HIV transmission. The proposed randomized clinical trial will rigorously test an innovative, couples-based intervention targeting the intersection of stimulant use and sexual risk behavior among racial/ethnic and sexual minorities, with the ultimate goal providing an evidence-based intervention that can be delivered in drug treatment and other service settings to reduce the spread of HIV among stimulant-using, African American/Black MSM.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 illicit use of psychostimulant and/or psychoactive drugs 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394900

Locations
United States, New York
Columbia University School of Social Work
New York, New York, United States, 10027
Sponsors and Collaborators
Columbia University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Elwin Wu, PhD Columbia University
  More Information

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: February 9, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

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 August 28, 2016