A Couples-based Intervention for Transgender Women and Their Partners

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Michigan
Study ID
NCT04067661
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • CHIP — BEHAVIORAL
    The couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors.
  • Control — BEHAVIORAL
    Enhanced standard of care, which includes information and referrals on HIV risk and prevention.

Study Details

This project seeks to test the efficacy of a couples-based HIV prevention program in large-scale randomized controlled trial (RCT) to reduce HIV risk among transgender woman and their partners. This project involves enrolling a racially diverse sample of transgender women and their partners and randomizing 50 couples to either the couples-based HIV prevention intervention or an enhanced standard of care (SOC) control condition. Couples will be followed quarterly over 12-months. Analysis of study outcomes will utilize both individual- and dyadic-level data. The primary outcome is a composite measure of risk for HIV transmission which encompasses validated behavioral indicators of HIV risk as well as biomedical confirmation of viral suppression and PrEP adherence.

Key Dates

Start date
Nov 1, 2019
Status verified
Jul 2025
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024

Study Design

Enrollment
104 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention
    Participants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors.
  • Active Comparator: Control
    Participants and their partners will receive information and referrals on HIV risk and prevention strategies.

Primary Outcome Measure

Condomless Sex [ Time Frame: Changes in self-reported condomless anal or vaginal sex at 12-month follow-up ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158-

Find similar trials in San Francisco, CA

By condition
HIV
By specialty
Infectious disease
By research site
University of California, San Francisco· San Francisco, CA

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