NCT05833074

Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Hunter College of City University of New York · Academic / Other
• Sex: Male
• Age: 17 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial evaluates the efficacy of couples HIV testing and counseling retesting. Eligible couples previously enrolled in NCT05000866 are invited to participate. Those who do are randomized to either couples HIV testing and counseling (CHTC) retesting or an individual HIV testing control. Follow-ups occur 3 and 6 months post intervention.

Detailed description

The purpose of this study is to evaluate the benefits associated with couples HIV testing and counseling (CHTC) resting. After their 12-month follow-up, those participants who remain in the same relationship they were in at the time of their baseline will be offered the opportunity to continue in the components proposed in this revision. Those who consent will be randomized to either complete a second session of CHTC or to a comparison condition in which both partners receive a routine individual HIV test. HIV positive partners in serodiscordant couples randomized to the control condition will receive information about anti-retroviral treatment adherence and U=U (undetectable = untransmissible). Given potential attrition and rates of relationship dissolution, we anticipate randomizing 200 couples (80% of the original sample). Follow-up assessments will be conducted 3 and 6 months after retesting (15 and 18 months after the participants' original baseline appointment).

Conditions

• HIV Infections

Interventions

Type	Name	Description
BEHAVIORAL	Couples HIV testing and counseling	Couples HIV testing follows a CDC published protocol for delivery of HIV testing to relationship partners. HIV test results are obtained from Oraquick (FDA approved for at home HIV testing)
BEHAVIORAL	Individual HIV testing and counseling	Individual HIV testing and counseling uses a counseling protocol based on the standard of care for routine HIV pre- and post-test counseling. HIV test results are obtained from Oraquick (FDA approved for at home testing)

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2023-04-27
• Last updated: 2025-06-13

Locations

2 sites across 1 country: United States