Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty Study

NCT06436560 | Enrolling By Invitation DMC

• 2 other identifiers: STUDY000269571023677
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 9

Brief Summary

The STRIVE study is the first national randomized trial to focus on improving well-being, access to surgical care and other health outcomes for transgender and nonbinary (referred to as trans) people seeking genital gender-affirming surgery (GGAS). Trans people have gender identities that are different from the sex they were assigned at birth. Due to discrimination based on their gender identity in settings such as schools, the workplace, housing and health care, trans people face much higher rates of distress as well as poorer health and quality of life. Trans people are often unable to access necessary surgeries and hormone therapy to help align their bodies with their gender identities due to a lack of trained medical providers and limited insurance coverage for gender-affirming care. The most common GGAS that trans people seek is vaginoplasty, which is the surgical creation of vaginal anatomy. Because of the high demand for this surgery and limited number of medical centers that offer it, trans people face lengthy wait times and complicated health system processes, increasing stress, negative mental health effects and social isolation. Social and peer-support interventions have been shown to decrease isolation and improve health. Social support during the GGAS process was also identified by the Transgender and Non-Binary Surgery - Allied Research Collective (TRANS-ARC) as the top research priority. Due to limited information on this topic, the STRIVE study was developed to meet this need. The research team's goals are to:

• Compare the effectiveness of two approaches to presurgical preparation for vaginoplasty: a virtual group-based peer support intervention led by trans peers who have had GGAS, or usual care delivered by gender-affirming surgical teams, enhanced with patient education materials.
• Determine if the intervention improves meeting presurgical criteria for vaginoplasty.
• Evaluate if patients, peer supporters and healthcare staff find the intervention acceptable. The research team will conduct a pragmatic randomized controlled trial, meaning participants will be assigned by chance to one of two groups: peer-support group or usual care enhanced with written and web-based education materials. This study is pragmatic because it is happening under real-life conditions to understand if the intervention will work in practice. The research team will work with five academic gender-affirming surgery programs across the country to recruit and enroll 290 trans adults ages 18 and older who are seeking vaginoplasty. Participants assigned to the peer support group will receive the intervention virtually over the course of three months, facilitated by peer facilitators trained in collaboration with Trans Lifeline. The usual care group will receive education from their gender-affirming surgical team, with in-depth materials that cover the same topics as the virtual course. The primary outcome to be measures at six months is coping self-efficacy, reported by patients, using a survey which assesses perceived ability to deal with stressors. The research team will explore additional outcomes at 12 months, including meeting GGAS presurgical criteria and other outcomes deemed important to trans community partners, surgeons and other gender-affirming providers (e.g., psychological stress, social support, resilience, quality of life, presurgical knowledge, surgical delays and cancellations). Postsurgical outcomes, including surgical satisfaction and other related outcomes, will be measured at 24 months. Finally, the team will conduct in-depth interviews with participants who undergo the intervention to understand their experiences at the beginning of the study and after six months. Researchers will also interview peer supporters and clinicians to understand how to improve and implement the support intervention more broadly. In designing this study, the research team worked closely with trans community members and patients, health services and policy researchers, gender-affirming surgeons, advocates, gender program administrators and representatives from social support organizations. Collaboration with and input from the trans community during the conduct of this study will be critical to ensure that the STRIVE study is patient centered. Results from this study will be shared in multiple forms, including clinical guideline recommendations, policy briefs, patient-centered reports, web-based information and summaries for clinicians and researchers. Trans people seeking gender-affirming surgery can use the study findings to understand options for social support to improve quality of life and health outcomes. Clinicians, gender program administrators, health insurance companies and health policy advisors can use the findings from this study to better support and prepare patients who are seeking gender-affirming surgery.

Conditions

Gender Affirmation Surgery; Perioperative Care; Transgender Health

Outcome Measures

Primary Outcomes (1)

• Patient-reported coping self-efficacy as assessed by the CSES

  Patient-reported coping self-efficacy is measured using the Coping Self-Efficacy Scale (CSES), a survey that assesses the perceived ability to deal with stressors using a score range of 0-260. Zero is equivalent to no perceived ability to deal with stressors; 260 indicates the highest attainable level of perceived ability to deal with stressors.

  Enrollment, 6 months after enrollment, 12 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative

Secondary Outcomes (1)

• Completion of preoperative criteria for scheduling GGAS

  Enrollment, 6 months after enrollment, 12 months after enrollment

Other Outcomes (14)

• Social support assessed by the MSPSS

  Enrollment, 6 months after enrollment, 12 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative

• Gender minority stress and resilience assessed by the GMSR

  Enrollment, 6 months after enrollment, 12 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative

• Health-Related Quality of Life assessed by the CDC HRQOL-4

  Enrollment, 6 months after enrollment, 12 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative

Study Arms (2)

STRIVE Peer Support Intervention

EXPERIMENTAL

A virtual group-based peer support intervention led by trans peers who have had genital gender-affirming surgery.

Other: STRIVE Peer Support Intervention

Enhanced Usual Care

NO INTERVENTION

Usual care enhanced with written and web-based education materials.

Interventions

STRIVE Peer Support Intervention OTHER

A virtual group-based peer support intervention led by trans peers who have had genital gender-affirming surgery.

STRIVE Peer Support Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender and nonbinary persons seeking gender-affirming vaginoplasty.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified trans or non-binary individual
• Seeking vaginoplasty
• Completed consultation with gender-affirming surgeon for vaginoplasty
• Documented recommendation by surgeon for vaginoplasty
• Can complete survey responses online, by phone or on paper.
• Willing and able to participate in virtual peer support intervention
• Aged 18 or older
• English speaking
• Able to provide independent written consent

You may not qualify if:

• Do not speak English
• Cannot complete survey responses online, by phone, or on paper
• Are unwilling to participate in a virtual peer support intervention
• Have co-morbidities or other conditions that exclude them from candidacy for vaginoplasty
• Are currently involved in delivery of the STRIVE Intervention
• Are unable or unwilling to participate.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Patient-Centered Outcomes Research Institute: collaborator
• NYU Langone Health: collaborator
• Rush University: collaborator
• University of Utah: collaborator
• University of Minnesota: collaborator
• Temple University: collaborator
• University of California, San Francisco: collaborator
• University of Washington: collaborator
• Trans Lifeline: collaborator
• Whitman-Walker Institute: collaborator
• Duke University: collaborator
• Henry Ford Health System: collaborator

Study Sites (9)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

New York University Langone Health

New York, New York, 10017, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Sage L, Hart E, Meyer N, Hnilicka O, Penkin A, Poteat TC, Aguayo-Romero R, Comstock BA; STRIVE Publications Committee; Dy GW. Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study: protocol for a national randomised pragmatic trial. BMJ Open. 2026 Feb 12;16(2):e114287. doi: 10.1136/bmjopen-2025-114287.

  PMID: 41688114 DERIVED

Study Officials

• Geolani Dy, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)