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NCT Number: NCT06307977

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

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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Key information

Conditions

Substance Use Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University, Detroit, Michigan, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Couples Health Project

Behavioral

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

Other names: CHP

Primary outcomes

  1. Drug use Frequency

    Time frame: 9 Months

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

  2. Urine assay for drug use

    Time frame: 9 Months

    Positive urine screen for drug use assessed bi-annually

  3. CAS with casual partners

    Time frame: 9 Months

    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

Secondary outcomes

  1. Bacterial sexually transmitted infections

    Time frame: 9 Months

    Any chlamydia or gonorrhea diagnosis

  2. Binge Drinking

    Time frame: 9 Months

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

  3. PrEP Uptake

    Time frame: 9 months

    self-reported receipt of a PrEP-prescription

Study contacts

Contact information is provided by the study sponsor or research team.

Demetria Cain, PHD

CONTACT

[email protected]

212-206-7919

Tyrel J Starks, PHD

CONTACT

[email protected]

212-206-7919

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: CHP

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Mar 13, 2024
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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