Clinical Trial

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

Study acronym: 4Us
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated December 16, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-08-03; most recent amendment 2025-12-11.
Status change: Recruiting → Active, Not Recruiting 2025-12-11
Status change: Not Yet Recruiting → Recruiting 2021-11-24
Trial Details
NCT Number NCT05000866
Lead Sponsor Hunter College of City University of New York
Collaborators: National Institute on Drug Abuse (NIDA), University of Michigan
Conditions Substance Use, HIV Infections
Enrollment 484 participants
Start Date 2021-10-13
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-16