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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT01394900
First received: July 13, 2011
Last updated: July 2, 2015
Last verified: July 2015

July 13, 2011
July 2, 2015
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.
  • 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
  • Sexually transmitted infection (STI) incidence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Cumulative incidence of chlamydia and gonorrhea detected by biological assay
  • 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

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.

The study consists of a randomized clinical trial (RCT) with 240 stimulant-using, Black MSM couples (480 individuals). Following an initial, common orientation session, couples will be randomly assigned to the 4-session CNU intervention or a 4-session general wellness promotion (WP) intervention that will be an attention control condition. Consistent with the HIV prevention literature, behavioral sexual risk primary outcomes will be self-reported unprotected sex, condom use, and number of sexual partners; these data, as well as self-reported drug-related risk primary outcomes, will be collected via audio computer-assisted self interview (ACASI). Primary outcomes will also be objectively measured via biological assay for infection by Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, and Ureaplasma urealyticum, which are the most prevalent, treatable STIs among MSM and disproportionately affecting Black MSM, Measurements will take place prior to the onset of sessions and randomization ("baseline"), and at 3, 6, and 12 months post-intervention.

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 using stimulants 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 using stimulants 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.
 
Recruiting
480
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 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
Male
18 Years and older
Yes
Contact: Elwin Wu, PhD 212.851.2397 ew157@columbia.edu
United States
 
NCT01394900
AAAI5452, 1R01DA030296-01A1, 1R01DA030296-01A1
No
Columbia University
Columbia University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Elwin Wu, PhD Columbia University
Columbia University
July 2015

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