Peer Support for Gender Confirmation Surgery

(STRIVE Trial)

Enrolling by invitation at 7 trial locations

Overseen By Loren Schechter, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Non-English, Survey inability, Vaginoplasty exclusion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance the well-being and access to care for transgender and nonbinary individuals seeking genital gender-affirming surgery, specifically vaginoplasty (the surgical creation of vaginal anatomy). It will compare two approaches: the STRIVE Peer Support Intervention, a virtual peer support led by trans peers who have undergone gender-affirming surgery, and usual care with educational materials. The researchers aim to determine if these support methods help patients better meet presurgical requirements and improve overall health outcomes. This trial targets trans or nonbinary individuals who have decided on vaginoplasty and are ready to engage in virtual support. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance support systems for future patients.

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 prior data suggests that the STRIVE Peer Support Intervention is safe?

Research has shown that peer support programs are generally safe and can improve mental health and social connections. In the STRIVE study, the first of its kind, participants receive support from other trans individuals who have undergone similar surgeries. Although specific safety data for this peer support program is not available, such support is commonly used in healthcare and is known to reduce feelings of loneliness and stress.

The STRIVE study was developed with input from the trans community, ensuring the program remains respectful and supportive. This collaboration suggests that participants will likely find the program helpful. Overall, based on existing knowledge about peer support, the STRIVE Peer Support Program is expected to be safe and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STRIVE Peer Support Intervention because it offers a unique, community-driven approach for individuals undergoing gender confirmation surgery. Unlike traditional support options, which might include standard counseling and educational materials, STRIVE is led by trans peers who have already experienced genital gender-affirming surgery, providing relatable insights and empathetic support. This virtual, group-based format not only fosters a sense of community but also offers accessibility and convenience, making it easier for participants to connect and share their experiences from anywhere.

What evidence suggests that the STRIVE Peer Support Intervention could be effective for improving well-being and access to surgical care for trans people seeking gender-affirming surgery?

Research has shown that peer support can greatly improve mental health and well-being for transgender people. Social and peer-support programs reduce feelings of isolation and boost health. In this trial, participants will join one of two groups. The STRIVE Peer Support Intervention group provides online peer support led by trans individuals who have undergone gender-affirming surgery, aiming to help others prepare for their own surgeries. While specific data on effectiveness in this setting is still being collected, similar support programs have shown promising results, suggesting potential benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Geolani Dy, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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

Exclusion Criteria

Cannot complete survey responses online, by phone, or on paper

Have co-morbidities or other conditions that exclude them from candidacy for vaginoplasty

I do not want to join online support groups.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: STRIVE Peer Support Intervention Experimental Treatment 1 Intervention

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

Group II: Enhanced Usual Care Active Control 1 Intervention

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

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06436560

Support for Transgender and Non-Binary Individuals ... 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 ...

2. withpower.com withpower.com/trial/phase-gender-affirmation-surgery-10-2024-86ce8

Peer Support for Gender Confirmation Surgery (STRIVE 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 ...

3. strivesupport.org strivesupport.org/

STRIVE STRIVE study is the largest research study of its kind and has been designed in close collaboration with trans community members every step of the way.

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06436560

Support for Transgender and Non-Binary Individuals Seeking ... The STRIVE study is the first national randomized trial to focus on improving well-being, access to surgical care and other health outcomes ...

5. pcori.org pcori.org/research-results/2023/comparing-virtual-peer-support-usual-care-adults-undergoing-vaginoplasty

Comparing Virtual Peer Support to Usual Care for Adults ... This study compares the clinical effectiveness of a virtual peer support group versus usual care among adults seeking vaginoplasty.

6. strivesupport.org strivesupport.org/faq.html

STRIVE Study Participants FAQ STRIVE stands for Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty. Our goal is to help make the experience of getting vaginoplasty more ...