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

HIV Infections Clinical Trial

— CHP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06307977
• Other study ID #: R01DA059272
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: February 2029

Study information

• Verified date: April 2024
• Source: Hunter College of City University of New York
• Contact: Tyrel J Starks, PHD
• Phone: 212-206-7919
• Email: tstarks[@]hunter.cuny.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: February 2029
• Est. primary completion date: January 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Couples Health Project
A 3-session, couples motivational Interviewing drug use and HIV risk reduction intervention

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Wayne State University	Detroit	Michigan
United States	Hunter College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hunter College of City University of New York	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Urine assay for drug use	Positive urine screen for drug use assessed bi-annually	9 Months
Primary	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	Bacterial sexually transmitted infections	Any chlamydia or gonorrhea diagnosis	9 Months
Secondary	Binge Drinking	Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview	9 Months
Secondary	PrEP Uptake	self-reported receipt of a PrEP-prescription	9 months