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

NCT06307977 | Recruiting DMC

• 1 other identifier: R01DA059272
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (3)

• 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

  9 Months

• Urine assay for drug use

  Positive urine screen for drug use assessed bi-annually

  9 Months

• 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

  9 Months

Secondary Outcomes (3)

• Bacterial sexually transmitted infections

  9 Months

• Binge Drinking

  9 Months

• PrEP Uptake

  9 months

Study Arms (2)

No Intervention: CHTC as usual

NO INTERVENTION

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

Behavioral: Couples Health Project

ACTIVE COMPARATOR

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

Couples Health Project BEHAVIORAL

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

Also known as: CHP

Behavioral: Couples Health Project

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Both partners in the couple must identify as male.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunter College of City University of New York: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Wayne State University

Detroit, Michigan, 48201, United States

ACTIVE NOT RECRUITING

Hunter College

New York, New York, 10018, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22904, United States

ACTIVE NOT RECRUITING

Related Publications (1)

• 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.

  PMID: 39563247 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; HIV Infections

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Tyrel J Starks, PHD

CONTACT

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

Demetria Cain, PHD

CONTACT

212-206-7919; dcain@prideresearch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: May 25, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)