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

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 Overview

• Status: Not yet recruiting
• Conditions: HIV Infections; Substance Use
• Intervention / Treatment: Behavioral: Couples Health Project

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tyrel J Starks, PHD; Phone Number: 212-206-7919; Email: tstarks@hunter.cuny.edu
• Study Contact Backup: Name: Demetria Cain, PHD; Phone Number: 212-206-7919; Email: dcain@prideresearch.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
      • Contact: Angulique Outlaw, PHD; Email: aoutlaw@med.wayne.edu
  • New York
    • New York, New York, United States, 10018
      • Hunter College
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • University of Virginia
      • Contact: Karen Ingersoll; Email: kes7a@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 34; 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; A 3-session, couples motivational Interviewing drug use and HIV risk reduction intervention; Other Names: CHP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial sexually transmitted infections	Any chlamydia or gonorrhea diagnosis	9 Months
Binge Drinking	Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview	9 Months
PrEP Uptake	self-reported receipt of a PrEP-prescription	9 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: R01DA059272 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No