NCT05000866

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 484 (actual)
• Sponsor: Hunter College of City University of New York · Academic / Other
• Sex: Male
• Age: 17 Years – 29 Years
• Healthy volunteers: Accepted

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.

Conditions

• Substance Use
• HIV Infections

Interventions

Type	Name	Description
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.
BEHAVIORAL	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.

Timeline

• Start date: 2021-10-13
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2021-08-11
• Last updated: 2025-12-16

Locations

2 sites across 1 country: United States