A Couples-based Intervention for Transgender Women and Their Partners

NCT04067661 | Terminated Results DMC

• 2 other identifiers: F0508375R01MH115765-05
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV Prevention; Transgender Women; Intervention

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Participants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors.

Behavioral: CHIP

Control

ACTIVE COMPARATOR

Participants and their partners will receive information and referrals on HIV risk and prevention strategies.

Behavioral: Control

Interventions

CHIP BEHAVIORAL

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

Also known as: It Takes Two

Intervention

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• University of California, San Francisco: collaborator
• Emory University: collaborator
• Research Foundation for Mental Hygiene, Inc.: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (3)

• 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.

  PMID: 30003506 RESULT

• 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.

  PMID: 32415617 RESULT

• 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.

  PMID: 33060086 RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Kristi Gamarel
• Organization: University of Michigan

kgamarel@umich.edu

7346473178

Study Officials

• Ellen Stein

  University of California, San Francisco

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study involved a randomized controlled trial comparing the couples-based HIV prevention to an enhanced standard of care control condition

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 26, 2019
• Study Start: November 1, 2019
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 6, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)