Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty Study

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · May 24, 2024

Keywords

ClinConnect Summary

STRIVE is a national, patient-centered study that tests whether a virtual, group-based peer-support program (led by transgender and nonbinary people who have had vaginoplasty) improves well-being for adults seeking genital gender-affirming surgery. In this randomized trial, about 260 participants will be assigned by chance to either the STRIVE Peer Support Intervention or Enhanced Usual Care (standard surgical care plus written and web-based education). The main goal is to see if peer support improves coping with stress six months after enrollment. Researchers will also look at whether the program helps more people meet the pre-surgical criteria for vaginoplasty at 12 months, and they will explore effects on mental health, social support, knowledge about the surgery, and various patient-reported outcomes before and after surgery. The study is being conducted at multiple U.S. centers.

To be eligible, participants must be adults (18+), identify as transgender or nonbinary, be seeking vaginoplasty, have completed a surgical consultation with a gender-affirming surgeon and have a documented surgical recommendation, and be able to participate in the program and surveys in English (online, by phone, or on paper). Those who do not meet these criteria, do not speak English, are unwilling to participate in virtual peer support, have medical conditions that exclude vaginoplasty, or are already involved in STRIVE, would not be eligible. The trial is currently enrolling by invitation and aims to finish in 2028, with results to help patients, clinicians, insurers, and policy makers understand the best ways to provide social support during the vaginoplasty process.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.