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

NCT01394900 | Completed

• 2 other identifiers: AAAI54521R01DA030296-01A1
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Sexually Transmitted Infections

Keywords

HIV; sexually transmitted infection; STI; men who have sex with men; MSM; couples; African American; Black

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Difference in incidence of sexually transmitted infections (STIs) between 2 groups

  12 months

• Difference in number of illicit drug use between 2 groups

  12 months

Study Arms (2)

CNU intervention

EXPERIMENTAL

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

WP intervention

ACTIVE COMPARATOR

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

Interventions

CNU Intervention BEHAVIORAL

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.

Also known as: Connect 'n Unite (CNU) Intervention

CNU intervention

WP Intervention BEHAVIORAL

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.

Also known as: Wellness Promotion (WP) Intervention

WP intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Columbia University School of Social Work

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases; Homosexuality

Interventions

1-(2-chloroethyl)-1-nitrosourea; Methods

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Elwin Wu, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 15, 2011
• Study Start: July 1, 2012
• Primary Completion: December 31, 2016
• Study Completion: August 2, 2019
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

US (1)