Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

July 13, 2011
February 9, 2016
July 2012
November 2016   (final data collection date for primary outcome measure)
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.
  • 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)
Complete list of historical versions of study NCT01394900 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Connect 'n Unite: Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM
Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • HIV
  • Sexually Transmitted Infections
  • 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
  • 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
  • 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
    Intervention: Behavioral: 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
    Intervention: Behavioral: WP Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
424
November 2016
November 2016   (final data collection date for primary outcome measure)

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
Male
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01394900
AAAI5452, 1R01DA030296-01A1
No
Undecided
Not Provided
Elwin Wu, Columbia University
Columbia University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Elwin Wu, PhD Columbia University
Columbia University
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP