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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Hunter College of City University of New York
Study ID
NCT05833074
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
MALE
Age
17 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Couples HIV testing and counseling — BEHAVIORAL
    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)
  • Individual HIV testing and counseling — BEHAVIORAL
    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)

Study Details

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.

Key Dates

Start date
Apr 1, 2023
Status verified
Jun 2025
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
384 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Couples HIV testing and counseling retesting
    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.
  • Active Comparator: Individual HIV testing
    Individual HIV testing and counseling.

Primary Outcome Measure

number of condomless anal sex acts with a casual partner in the absence of PrEP [ Time Frame: 6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109-
Hunter CollegeNew YorkNew York10018-

Find similar trials in Ann Arbor, MI

By condition
HIV
By specialty
Infectious disease
By research site
University of Michigan· Ann Arbor, MIHunter College· New York, NY

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