Recruiting

Couples MI

Sponsor:

Hunter College of City University of New York

Code:

NCT06307977

Conditions

Substance Use

HIV Infections

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Couples Health Project

Study Details

Brief summary:

This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC).

Conditions

Substance Use

HIV Infections

Study ID

NCT06307977

Start date

May 25, 2024

Status verified date

Sep, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Have a main partner who is another cisgender male and have been in a relationship for 3 month or longer
  • Index participant must be between 18 and 55; Main partner can be any age 18 and older
  • One participant must be HIV negative (as confirmed by rapid test)
  • One participant must have used at least 1 drug in the past 30 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB, amyl nitrite)
  • Index participant must have engaged in TRB in the past 30 days- Defined as CAS with a casual partner, or a serodiscordant or non-monogamous main partner
  • Live in the United States
  • Speak and read English

Exclusion Criteria

  • Any signs of serious mental illness or cognitive deficit
  • Current suicidal/homicidal ideations
  • History of IPV with their main partner and safety concerns in the current relationship.

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: No Intervention: CHTC as usual

Participants complete the standard Couples HIV Testing and Counseling session (CHTC).

active comparator: Behavioral: Couples Health Project

A three-session intervention for couples addressing couples communication skills, substance use, sexual agreements. The intervention also includes couples HIV testing and counseling in the final session.

Interventions

Couples Health Project

A 3-session, couples motivational Interviewing drug use and HIV risk reduction intervention

Primary outcome measure

  • Drug use Frequency [ Time Frame: 9 Months ]
  • Urine assay for drug use [ Time Frame: 9 Months ]
  • CAS with casual partners [ Time Frame: 9 Months ]

Central Contacts and Locations

Central contacts

Tyrel J Starks, PHD

212-206-7919tstarks@hunter.cuny.edu

Demetria Cain, PHD

212-206-7919dcain@prideresearch.org

Locations

Hunter College

Recruiting

New York, New York, United States, 10018

Contacts

Tyrel J Starks

212-206-7919tstarks@hunter.cuny.edu

Demetria Cain

212-206-7919dcain@prideresearch.org

More Information

Sponsor

Hunter College of City University of New York

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-12. This information was provided to ClinicalTrials.gov by Hunter College of City University of New York on 2026-09-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.