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

Not Applicable

Completed

• Conditions: HIV; Sexually Transmitted Infections
• Interventions: Behavioral: CNU Intervention; Behavioral: WP Intervention

• Registration Number: NCT01394900
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-15
• Study Start: 2012-07
• Primary Completion: 2016-12-31
• Study Completion: 2019-08-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 424

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CNU intervention	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
WP intervention	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

Primary Outcome Measures

Name	Time	Method
Difference in number of unprotected acts of anal intercourse between 2 groups	12 months	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

Name	Time	Method
Difference in incidence of sexually transmitted infections (STIs) between 2 groups	12 months	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	12 months	To test whether participants assigned to CNU engage in less drug use compared to participants assigned to WP.

Trial Locations

Locations (1)

Columbia University School of Social Work; 🇺🇸 New York, New York, United States