260 Participants Needed

Peer Support for Gender Confirmation Surgery

(STRIVE Trial)

Recruiting at 7 trial locations
ER
SU
CA
LS
Overseen ByLoren Schechter, MD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Oregon Health and Science University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The research does not provide specific safety data on peer support for gender confirmation surgery, but it does mention that gender-affirming surgeries generally have minimal adverse events, suggesting a focus on safe and affirming care.12456

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

GD

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

Able to provide independent written consent
My surgeon has recommended a vaginoplasty for me.
Willing and able to participate in virtual peer support intervention
See 5 more

Exclusion Criteria

Cannot complete survey responses online, by phone, or on paper
I do not want to join online support groups.
Have co-morbidities or other conditions that exclude them from candidacy for vaginoplasty
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either a virtual group-based peer support intervention or enhanced usual care with education materials

3 months
Virtual sessions for peer support group

Pre-operative Assessment

Participants are assessed for meeting pre-operative criteria for vaginoplasty

12 months

Post-operative Follow-up

Participants are monitored for surgical satisfaction and other outcomes

6 months post-operative

Treatment Details

Interventions

  • STRIVE Peer Support Intervention
Trial Overview This trial tests if virtual group-based peer support led by trans individuals who've had gender-affirming surgery can better prepare patients for vaginoplasty compared to standard care with educational materials. The effectiveness will be measured through coping skills, meeting surgical criteria, and other health outcomes.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: STRIVE Peer Support InterventionExperimental Treatment1 Intervention
A virtual group-based peer support intervention led by trans peers who have had genital gender-affirming surgery.
Group II: Enhanced Usual CareActive Control1 Intervention
Usual care enhanced with written and web-based education materials.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Whitman-Walker Institute

Collaborator

Trials
4
Recruited
1,800+

NYU Langone Health

Collaborator

Trials
1,431
Recruited
838,000+

University of Utah

Collaborator

Trials
1,169
Recruited
1,623,000+

Rush University

Collaborator

Trials
46
Recruited
3,294,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+

Temple University

Collaborator

Trials
321
Recruited
89,100+

University of Washington

Collaborator

Trials
1,858
Recruited
2,023,000+

References

Patient-Reported Outcome Measures in Gender-Affirming Surgery. [2023]
Patient-Reported Outcome Measures Used in Gender Confirmation Surgery: A Systematic Review. [2022]
International phase I study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q). [2019]
Current Concepts in Gender-Affirming Surgery Postgraduate Training. [2022]
Patient reported outcomes in genital gender-affirming surgery: the time is now. [2022]
A Single Center Case Series of Gender-Affirming Surgeries and the Evolution of a Specialty Anesthesia Team. [2022]
Training Surgeons in Gender Confirmation Surgery. [2023]
The postsurgical transsexual: empirical and theoretical considerations. [2019]
Epistemic Peerhood as a Model To Improve Gender-Affirming Care in Medical Education. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Experiences of surgery readiness assessments in British Columbia. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security