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A Couples-based Intervention for Transgender Women and Their Partners

NCT04067661 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-08-06

Study results available
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Summary

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.

Conditions

  • HIV Infections
  • HIV Primary Infection

Interventions

BEHAVIORAL

CHIP

The couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors.

BEHAVIORAL

Control

Enhanced standard of care, which includes information and referrals on HIV risk and prevention.

Sponsors & Collaborators

Principal Investigators

  • Ellen Stein · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04067661 on ClinicalTrials.gov