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

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.

Study Overview

• Status: Completed
• Conditions: HIV; Sexually Transmitted Infections
• Intervention / Treatment: Behavioral: CNU Intervention; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 424
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Columbia University School of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Wellness Promotion (WP) Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in number of unprotected acts of anal intercourse between 2 groups	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in incidence of sexually transmitted infections (STIs) between 2 groups	To test whether participants assigned to CNU have lower cumulative incidence of STIs confirmed via biological assay compared to participants assigned to WP.	12 months
Difference in number of illicit drug use between 2 groups	To test whether participants assigned to CNU engage in less drug use compared to participants assigned to WP.	12 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Elwin Wu, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: July 13, 2011
• First Submitted That Met QC Criteria: July 13, 2011
• First Posted (Estimated): July 15, 2011

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: HIV; African American; STI; MSM; men who have sex with men; couples; sexually transmitted infection; Black
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: AAAI5452; 1R01DA030296-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No