Clinical trial NCT06436560: Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty Study
Official title: Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty (STRIVE) Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gender Affirmation Surgery
Perioperative Care
Transgender Health
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: NYU Langone Health
name: Rush University
name: University of Utah
name: University of Minnesota
name: Temple University
name: University of California, San Francisco
name: University of Washington
name: Trans Lifeline
name: Whitman-Walker Institute
name: Duke University
First posted: 2024-05-31
Enrollment: 260
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: OUTLINE The STRIVE (Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty) Study is a multi-site, two-arm randomized pragmatic trial to determine if an evidence-based peer support intervention improves patient-reported and patient-centered clinical outcomes for individuals seeking genital gender-affirming surgery (GGAS) compared with enhanced usual care.

PRIMARY OBJECTIVES Aim 1: To compare the effectiveness of a virtual, group-based perioperative peer support intervention with enhanced usual care on coping self-efficacy (primary outcome) among patients seeking vaginoplasty.

* Hypothesis 1: Patients in the intervention arm will have greater improvements in coping self-efficacy at 6 months post-enrollment compared to patients who receive enhanced usual care.

Aim 2: To determine whether our perioperative peer support intervention improves patient probability of meeting pre-operative GGAS criteria (secondary outcome), and other prioritized patient-centered outcomes (exploratory outcomes).

* Hypothesis 2a: More patients in the intervention arm will meet pre-operative GGAS criteria at 12 months post-enrollment compared with patients who receive enhanced usual care.
* Hypotheses 2b: Patients in the intervention arm will have decreased psychological distress (anxiety, depression, suicidal ideation) and gender minority stress, and greater social support, resilience, QOL, pre-operative surgical knowledge, and fewer surgical delays. For participants who undergo surgery during the follow-up period, those in the intervention arm will have fewer surgical complications, greater completion of vaginal dilation, greater surgical satisfaction, and fewer unplanned emergency department and clinic visits at 6 months post-operatively.

Aim 3: To evaluate the acceptability of this centralized, virtual, group-based perioperative peer support intervention among patients, peer support specialists and healthcare team members.

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.

Primary outcomes:
measure: Patient-reported coping self-efficacy as assessed by the CSES
timeFrame: Enrollment, 6 months after enrollment, 6 months post-operative
Secondary outcomes:
measure: Completion of preoperative criteria for scheduling GGAS
timeFrame: Enrollment, 12 months after enrollment
Other outcomes:
measure: Health-related quality of life assessed by the PROMIS-29 Profile v2.0
timeFrame: Enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
measure: Depression assessed by the PHQ-9
timeFrame: Enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
measure: Anxiety assessed by the GAD-7
timeFrame: Enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
measure: Presurgical GGAS knowledge assessed by the GENDER-Q "Information" scale
timeFrame: Enrollment, 6 months after enrollment, immediate pre-operative
measure: Complications and adverse effects assessed by the GENDER-Q "Adverse Effects" scale
timeFrame: Immediate pre-operative, 3 months post-operative, 6 months post-operative
measure: Gender dysphoria life impact assessed by the GENDER-Q "Gender dysphoria life impact" scale
timeFrame: Enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
measure: Social support assessed by the MSPSS
timeFrame: Enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
measure: Sexual function assessed by the GENDER-Q "Sexual well-being" scale
timeFrame: Enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
measure: Bodily appearance satisfaction assessed by the GENDER-Q "Appearance" scale
timeFrame: Enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
measure: Urinary function assessed by the GENDER-Q "Urinary function" scale
timeFrame: Immediate pre-operative, 3 months post-operative, 6 months post-operative
measure: Satisfaction with healthcare team assessed by the GENDER-Q "Healthcare professional" and "Gender clinic" scales
timeFrame: Enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
measure: Satisfaction with vagina assessed by the GENDER-Q "Vagina" scale
timeFrame: Immediate post-operative, 3 months post-operative, 6 months post-operative
measure: Satisfaction with surgical outcome assessed by the GENDER-Q "Outcome of surgery" scale
timeFrame: Immediate post-operative, 3 months post-operative, 6 months post-operative
measure: Gender minority stress and resilience assessed by the GMSR
timeFrame: Enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: New York University Langone Health
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Oregon Health and Science University
name: Geolani Dy, MD
role: PRINCIPAL_INVESTIGATOR
References: