Overview

This trial is active, not recruiting.

Conditions hiv, sexually transmitted infections
Treatments cnu intervention, wp intervention
Sponsor Columbia University
Collaborator National Institute on Drug Abuse (NIDA)
Start date July 2012
End date November 2016
Trial size 424 participants
Trial identifier NCT01394900, 1R01DA030296-01A1, AAAI5452

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(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
cnu intervention Connect 'n Unite (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.
(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
wp intervention Wellness Promotion (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.

Primary Outcomes

Measure
Difference in number of unprotected acts of anal intercourse between 2 groups
time frame: 12 months

Secondary Outcomes

Measure
Difference in incidence of sexually transmitted infections (STIs) between 2 groups
time frame: 12 months
Difference in number of illicit drug use between 2 groups
time frame: 12 months

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM
Principal investigator Elwin Wu, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Columbia University.