Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study: protocol for a national...

Area of Science:

• Transgender health research
• Surgical outcomes
• Mental health interventions

Background:

• Transgender and gender-diverse individuals face significant barriers to gender-affirming care, impacting mental health and quality of life.
• Vaginoplasty is highly desired by transgender women but limited by surgeon availability and long wait times.
• Peer support shows promise for improving outcomes in marginalized populations but its efficacy in the perioperative period of vaginoplasty is unstudied.

Purpose of the Study:

• To evaluate the efficacy of a centralized peer support and education intervention for patients seeking vaginoplasty.
• To address a critical gap in perioperative care for individuals undergoing gender-affirming genital surgery.
• To build on priorities identified through multi-stakeholder engagement.

Main Methods:

• A pragmatic, multi-site randomized controlled trial (STRIVE Study) enrolling transgender adults seeking vaginoplasty.
• Participants randomized to enhanced usual care or a facilitated group intervention.
• Primary outcome: coping self-efficacy at 6 months; secondary outcome: surgical readiness. Analysis via intention-to-treat and linear mixed effects modeling.

Main Results:

• Primary analysis uses intention-to-treat approach with linear mixed effects modelling.
• Feasibility data will be analyzed thematically via qualitative interviews.
• Study registered (NCT06436560) and IRB approved (STUDY00026957).

Conclusions:

• The STRIVE study aims to evaluate the efficacy of a peer support intervention for vaginoplasty patients.
• Findings will address critical gaps in perioperative care for transgender and nonbinary individuals.
• Results will be disseminated via open access journals and plain language formats.