Actively Recruiting
Led by Hunter College of City University of New York · Updated on 2025-06-13
360
Participants Needed
3
Research Sites
56 weeks
Total Duration
H
Hunter College of City University of New York
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
Researchers are evaluating the effectiveness of couples motivational interviewing (MI) to reduce illicit drug use and risky HIV transmission behaviors in vulnerable male couples. This trial compares couples MI with the standard couples HIV testing and counseling (CHTC) to see which approach better supports behavior change. The study is designed as a randomized controlled trial focusing on male couples where at least one partner uses drugs and is at risk of HIV transmission. Participants are randomly assigned to one of two groups. One group receives the standard CHTC session, while the other participates in the Couples Health Project, a three-session intervention that covers communication skills, substance use, and sexual agreements, concluding with couples HIV testing and counseling. This behavioral intervention aims to improve relationship and health outcomes through motivational interviewing techniques. During the study, participants will be assessed over nine months for drug use frequency, confirmed through urine tests, and sexual behaviors related to HIV risk, such as condomless anal sex with casual partners. Secondary measures include bacterial sexually transmitted infections, binge drinking, and uptake of pre-exposure prophylaxis (PrEP). The study involves regular assessments to monitor progress and safety, with participation extending until nine months after enrollment.
CONDITIONS
Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 sessions over several weeks
Participants receive a three-session couples motivational interviewing intervention addressing communication skills, substance use, and sexual agreements, including couples HIV testing and counseling in the final session.
3 visits (in-person)
Duration - Up to 9 months
Participants are assessed for drug use frequency, urine drug assays, sexual risk behaviors, sexually transmitted infections, binge drinking, and PrEP uptake up to 9 months after intervention.
Periodic visits during follow-up
Total: 3 locations
1
Wayne State University
Detroit, Michigan, United States, 48201
Active, Not Recruiting
2
Hunter College
New York, New York, United States, 10018
Actively Recruiting
3
University of Virginia
Charlottesville, Virginia, United States, 22904
Active, Not Recruiting
T
Tyrel J Starks, PHD
D
Demetria Cain, PHD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Tyrel J Starks, Joseph R Hillesheim, Juan Castiblanco...
https://pubmed.ncbi.nlm.nih.gov/39563247