A Couples-based Intervention for Transgender Women and Their Partners (T2)

A Couples-Based Approach to HIV Prevention for Transgender Women and Their Male Partners

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.

Study Overview

• Status: Terminated
• Conditions: HIV Infections; HIV Primary Infection
• Intervention / Treatment: Behavioral: CHIP; Behavioral: Control

Detailed Description

Transgender women (trans women; individuals with a feminine and/or female gender identity who were assigned male at birth) are disproportionately affected by HIV. One of the most consistently reported contexts for HIV transmission among trans women is within a primary partnership. In this partnership context, trans women report low condom use, difficulty disclosing their HIV status and negotiating HIV prevention strategies, poor communication about whether they permit sex outside of the relationship, and low rates of routine HIV testing. Likewise, research among males who have sex with trans women has found high HIV prevalence, inconsistent condom use with trans women, and low engagement with HIV prevention services.

For the past 10 years the investigators have conducted research to identify intervention targets for reducing HIV transmission in trans women and their partner using qualitative, survey, and intervention adaptation methodologies. Based on these conceptual and empirical understandings of HIV transmission in these dyads, the investigative team developed and pilot tested the first known couples-based HIV prevention program for trans women and primary partners (called "Couples HIV Intervention Program" or CHIP). CHIP was feasible, acceptable, and produced significant reductions in condomless sex acts with primary and casual partners and in number of casual partners at 3-month follow-up compared to a control group.

The project seeks to test the efficacy of the CHIP intervention on reductions in a Composite Risk for HIV (CR-HIV) outcome. CR-HIV is a binary indicator of couple HIV risk using validated measures of sexual behavior (defined as condomless anal or vaginal sex with a serodiscordant or unknown HIV status primary or outside partner), as well as PrEP use among HIV-negative participants and viral suppression among HIV-positive partners. The study involves two-arm prospective RCT in which 50 trans women and their partners (100 participants) will complete a Baseline assessment and then complete assessments every 3 months for 12 months. Recruitment and study activities will occur in San Francisco, California.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18 or older
• Self-report that they are in emotional and/or sexual relationship for at least three months
• One partner must identify as a trans women (assigned the male gender at birth but identify as female or as a trans woman)
• Both partners must have engaged in condomless sex within the past 6 months with any partner
• Able to provide informed consent
• Speak and read English

Exclusion Criteria:

• Currently psychotic, suicidal, or manic
• Either partner reports that participating in the study would cause them physical harm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors.	Behavioral: CHIP; The couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors.; Other Names: It Takes Two
Active Comparator: Control; Participants and their partners will receive information and referrals on HIV risk and prevention strategies.	Behavioral: Control; Enhanced standard of care, which includes information and referrals on HIV risk and prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Condomless Sex	Self-report condomless anal or vaginal sex with any partner in the past 3 months	Changes in self-reported condomless anal or vaginal sex at 12-month follow-up
Composite HIV Risk	We created a composite measure incorporating self-reported condomless sex, PrEP adherence, and viral suppression, resulting in a binary HIV risk outcome (1=yes, 0=no). Participants reporting condomless sex in the past 30 days, along with either lack of viral suppression or non-adherence to PrEP, were categorized as at HIV risk. Conversely, those who did not report condomless sex, were virally suppressed, or were adherent to PrEP were placed in the not at HIV risk group. The variable was constructed such that 1= HIV Risk versus 0 = No HIV Risk. The results below represent the number of participants who were categorized as 1 = HIV risk at the 12-month follow up.	12 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Mental Health (NIMH); Emory University; University of California, San Francisco; Research Foundation for Mental Hygiene, Inc.
• Investigators: Study Director: Ellen Stein, University of California, San Francisco

Publications and helpful links

General Publications

• Gamarel KE, Chakravarty D, Neilands TB, Hoff CC, Lykens J, Darbes LA. Composite Risk for HIV: A New Approach Towards Integrating Biomedical and Behavioral Strategies in Couples-Based HIV Prevention Research. AIDS Behav. 2019 Jan;23(1):283-288. doi: 10.1007/s10461-018-2229-8.
• Sevelius JM, Gutierrez-Mock L, Zamudio-Haas S, McCree B, Ngo A, Jackson A, Clynes C, Venegas L, Salinas A, Herrera C, Stein E, Operario D, Gamarel K. Research with Marginalized Communities: Challenges to Continuity During the COVID-19 Pandemic. AIDS Behav. 2020 Jul;24(7):2009-2012. doi: 10.1007/s10461-020-02920-3. No abstract available.
• Gamarel KE, Sevelius JM, Neilands TB, Kaplan RL, Johnson MO, Nemoto T, Darbes LA, Operario D. Couples-based approach to HIV prevention for transgender women and their partners: study protocol for a randomised controlled trial testing the efficacy of the 'It Takes Two' intervention. BMJ Open. 2020 Oct 15;10(10):e038723. doi: 10.1136/bmjopen-2020-038723.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Intervention; HIV Prevention; Transgender Women
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: F050837; 5R01MH115765-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will compile structured de-identified datasets and can make them available for additional/secondary data analyses. For data sharing, the research team will follow the "standards for privacy of individually identifiable health information." Participants' records and results will not be identified. No contact information will be included in any archived datasets.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No