Clinical trial NCT01394900: Connect 'n Unite: Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM
Official title: Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Sexually Transmitted Infections
Keywords: HIV
sexually transmitted infection
STI
men who have sex with men
MSM
couples
African American
Black
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-07-15
Enrollment: 424
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Difference in number of unprotected acts of anal intercourse between 2 groups
timeFrame: 12 months
Secondary outcomes:
measure: Difference in incidence of sexually transmitted infections (STIs) between 2 groups
timeFrame: 12 months
measure: Difference in number of illicit drug use between 2 groups
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University School of Social Work
state: New York
Study officials:
affiliation: Columbia University
name: Elwin Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: