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

Not Applicable

• Conditions: HIV Infections
• Interventions: Behavioral: Individual HIV testing and counseling; Behavioral: Couples HIV testing and counseling

• Registration Number: NCT05833074
• Lead Sponsor: Hunter College of City University of New York

Brief 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).

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 384

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual HIV testing	Individual HIV testing and counseling	Individual HIV testing and counseling.
Couples HIV testing and counseling retesting	Couples HIV testing and counseling	Couples HIV testing and counseling is completed following Centers for Disease Control and Prevention (CDC) standard protocol. Participants also complete any adjunct CHTC components associated with their originally assigned condition in NCT05000866.

Primary Outcome Measures

Name	Time	Method
number of condomless anal sex acts with a casual partner in the absence of PrEP	6 months	Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments

Secondary Outcome Measures

Name	Time	Method
Binge drinking	6 months	Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview
PrEP adherence	6 months	taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments
pre-exposure prophylaxis (PrEP) uptake	6 months	self-reported receipt of a PrEP-prescription
Drug use Frequency	6 months	Number of reported days of illicit drug use (amphetamines, cocaine/crack, gama hydroxybutyric acid (GHB), ketamine or ecstasy) reported on quarterly timeline follow-back assessments

Trial Locations

Locations (2)

Hunter College; 🇺🇸 New York, New York, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States