Study of Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Male Couples Ages 18 to 55
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
AI-Summary
What this Trial Is About
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
Brief Title
Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples
Research Team
T
Tyrel J Starks, PHD
D
Demetria Cain, PHD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Couples Health Project (3-session couples motivational interviewing)
Standard Counseling, HIV Testing, and Referral (Usual Care)
What it is
A structured 3-session behavioral program delivered to male couples, using motivational interviewing to address drug use and HIV sexual risk behaviors together.
Standard counseling, HIV testing, and referral provided to male couples, following usual clinic practices for risk reduction and testing.
Role in the trial
Experimental arm testing whether couples-focused motivational interviewing can reduce drug use and sexual risk behaviors.
Control group receiving the standard-of-care counseling and HIV testing for comparison.
Primary use or goal
Aims to help male couples reduce drug use and sexual practices that increase HIV risk by building motivation and concrete strategies together.
Provides counseling about health risks, HIV testing, and referrals to support reductions in substance use and sexual risk.
How it is given or performed
Delivered over three structured sessions with both partners present, guided by a trained facilitator using motivational interviewing techniques.
Standard counseling and HIV testing session(s) as typically provided in clinics; may involve risk assessment, testing, and referrals.
Evidence status
Under active randomized trial; no published trial outcome data available yet. Effectiveness in reducing drug use or HIV risk among male couples has not been established.
Widely used approach for counseling and testing male couples at risk for HIV and substance use. Actual outcomes in this trial contingent on pending results.
Important limitations
Effectiveness is not yet known because the trial is ongoing. Generalizability may be limited to male couples who meet the specific eligibility criteria. The intervention is only supported by protocol description at this time.
Counseling and testing as usual-care control may vary by site and provider, which can influence outcomes. Specific effects within this trial population are not published yet.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years - 55Years
MALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Have a main partner who is another cisgender male and have been in a relationship for 3 months or longer
Index participant must be between 18 and 55 years old; main partner can be any age 18 or older
One participant must be HIV negative as confirmed by rapid test
One participant must have used at least one drug in the past 30 days (including cocaine/crack, opiates, prescription medication misuse, stimulants, psychedelics, ecstasy, ketamine, GHB, amyl nitrite)
Index participant must have engaged in transmission risk behavior in the past 30 days, defined as condomless anal sex with a casual partner or a serodiscordant or non-monogamous main partner
Live in the United States
Speak and read English
You will not qualify if you...
Any signs of serious mental illness or cognitive deficit
Current suicidal or homicidal thoughts
History of intimate partner violence with main partner and safety concerns in the current relationship
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
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)
Follow-up
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Published Research Related To This Trial
A protocol for a randomized controlled trial of couples motivational interviewing to reduce drug use and HIV transmission risk among male couples in the US: the Couples Health Project.
Tyrel J Starks, Joseph R Hillesheim, Juan Castiblanco...