Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples

HIV Infections Clinical Trial

— 4Us  

Official title:

Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000866
• Other study ID #: R01DA050508
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2021
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: Hunter College of City University of New York
• Contact: Tyrel J Starks
• 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 two intervention components for couples HIV testing and counseling (CHTC): a communication skills training video and a substance use module. Participants are randomized in a full-factorial design to one of 4 conditions: CHTC as usual; CHTC + communication skills training videos; CHTC + substance use module; or CHTC plus both adjunct components.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 17 Years to 29 Years

Eligibility

Inclusion Criteria:

• · Have a main partner who is another male and have been in a relationship for 3 month or longer
• One participant must be between 17 and 29; Main partner can be any age above 17.
• One participant must be HIV negative (as confirmed by rapid test)
• One participant must have used at least 1 drug in the past 90 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB)
• One participant must have engaged in Transmission Risk Behavior (TRB) in the past 90 days o Defined as Condom-less Anal Sex (CAS) with a casual partner and/or CAS with a non-monogamous or serodiscordant main partner
• Live in the NYC or Detroit metropolitan area
• Speak English

Exclusion Criteria:

• · Any signs of serious mental illness or cognitive deficit
• 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:
• Communication skills training video
The communication skills training video component is designed to be self-delivered. Four couples are depicted in separate scenes discussing HIV testing, drug use, sexual agreements, and drug use during sex. Each scene is viewed twice. In the initial viewing, the couple in the video makes one or more communication errors. The scene is subsequently viewed a second time and the couple utilizes more effective communication skills, resulting in a more adaptive resolution. Each scene is introduced by a narrator who points out communication errors and orients viewers to skills utilized in adaptive versions of each scene.
• Drug use module
The substance use module is administered after step 5 of CHTC and prior to the delivery of rapid HIV-test results. The couple was first asked to fill in a calendar for the past 30 days, indicating each day on which either member used drugs or consumed alcohol. Completion of the calendar is done through an ACCESS database to facilitate remote intervention delivery. After completion of the calendar, the HIV tester asked a series of debriefing questions designed to elicit the couples' perspective on their use, establish the couple's goals and limits for drug use, and make plans to achieve these goals.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Hunter College	New York	New York

Sponsors (3)

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

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	12 months
Primary	Urine assay for drug use	Positive urine screen for drug use assessed bi-annually	12 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	12 months
Primary	Bacterial STI's	Any chlamydia or gonorrhea diagnosis assessed bi-annually	12 months
Secondary	Binge drinking	Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview	12 months
Secondary	Syphilis infection	Reactive RPR test assessed bi-annually	12 months
Secondary	PrEP Uptake	self-reported receipt of a PrEP-prescription	12 months
Secondary	PrEP adherence	taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments	12 months