Peer Support for Gender Confirmation Surgery
(STRIVE Trial)
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment STRIVE Peer Support Intervention for gender confirmation surgery?
The research highlights the importance of patient-reported outcome measures (PROMs) in gender-affirming surgery, which can help align patients' goals and expectations with surgical outcomes. While specific data on the STRIVE Peer Support Intervention is not provided, the use of PROMs in similar contexts suggests that patient-centered approaches, like peer support, can enhance the quality of care and decision-making for gender-affirming surgeries.12345
Is peer support for gender confirmation surgery safe for humans?
How does the STRIVE Peer Support Intervention treatment differ from other treatments for gender confirmation surgery?
The STRIVE Peer Support Intervention is unique because it focuses on providing peer support to individuals undergoing gender confirmation surgery, emphasizing the value of lived experiences and community knowledge, which is not typically a component of standard medical treatments for this condition.478910
What is the purpose of this trial?
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 260 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 from 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.
Research Team
Geolani Dy, MD
Principal Investigator
Oregon Health and Science University
Eligibility Criteria
The STRIVE study is for transgender and nonbinary adults aged 18 or older seeking vaginoplasty. It aims to improve their well-being by comparing a virtual peer support intervention with usual care. Participants must be planning to undergo surgery at one of the participating centers.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive either a virtual group-based peer support intervention or enhanced usual care with education materials
Pre-operative Assessment
Participants are assessed for meeting pre-operative criteria for vaginoplasty
Post-operative Follow-up
Participants are monitored for surgical satisfaction and other outcomes
Treatment Details
Interventions
- STRIVE Peer Support Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Whitman-Walker Institute
Collaborator
NYU Langone Health
Collaborator
University of Utah
Collaborator
Rush University
Collaborator
University of California, San Francisco
Collaborator
University of Minnesota
Collaborator
Temple University
Collaborator
University of Washington
Collaborator