ClinicalTrials.gg
RecruitingNCT06307977CHPUpdated Sep 17, 2026

Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples

An interventional study of Couples Health Project in Substance Use and HIV Infections, sponsored by Hunter College of City University of New York. Recruiting at 3 sites in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Hunter College of City University of New York · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
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Study 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).

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Conditions studied

  • Substance Use
  • HIV Infections
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In context

Substance-Related Disorders

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

This study's planned enrollment of 360 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Hunter College of City University of New York is the lead sponsor of 36 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
360 participants (estimated)

Study 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.

    Behavioral: Couples Health Project

Interventions

  • BehavioralCouples Health Project

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

    Also known as: CHP

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What researchers measure

Primary outcomes

  1. Drug use Frequency

    Number of reported days of illicit drug use (amphetamines, cocaine/crack, GHB, ketamine or ecstasy) reported on quarterly timeline follow-back assessments

    Time frame: 9 Months

  2. Urine assay for drug use

    Positive urine screen for drug use assessed bi-annually

    Time frame: 9 Months

  3. CAS with casual partners

    Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments in the absence of adequate PrEP coverage

    Time frame: 9 Months

Secondary outcomes

  1. Bacterial sexually transmitted infections

    Any chlamydia or gonorrhea diagnosis

    Time frame: 9 Months

  2. Binge Drinking

    Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview

    Time frame: 9 Months

  3. PrEP Uptake

    self-reported receipt of a PrEP-prescription

    Time frame: 9 months

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Study locations

1 of 3 sites recruiting
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References and documents

Publications

  • Starks TJ, Hillesheim JR, Castiblanco J, Robles G, S Ingersoll K, Outlaw AY, Cain D. 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. BMC Public Health. 2024 Nov 19;24(1):3216. doi: 10.1186/s12889-024-20719-y. PubMed 39563247 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06307977
Lead sponsor
Hunter College of City University of New York
Responsible party
Tyrel Starks (Professor, Hunter College of City University of New York) — Principal investigator
First posted
Mar 13, 2024
Start date
May 25, 2024
Primary completion
Jan 2028 (estimated)
Completion
Feb 2029 (estimated)
Last update
Sep 17, 2026

Study contacts

Tyrel J Starks, PHD
Contact
tstarks@hunter.cuny.edu
212-206-7919
Demetria Cain, PHD
Contact
dcain@prideresearch.org
212-206-7919

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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