Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Flourish Vaginal Care System to Establish Neovaginal Microbiome

NCT05372770

Neovaginal Microbiome

COMPLETED NA

Feasibility of an Oral Intervention for Sexual Health in Transgender Men

NCT06470906

Vaginal Dysbiosis Vaginal Disease Molecular-bacterial Vaginosis

COMPLETED NA

Exploration of the Neo-Vagina Study

NCT03049371

HIV Infections Transgender Women

COMPLETED NA

Vaginal Injection of Platelet Rich Plasma for Sexual Function

NCT05769283

Sexual Behavior Sexual Activity

COMPLETED NA

Trial of Male Circumcision: HIV, Sexually Transmitted Disease (STD) and Behavioral Effects in Men, Women and the Community

NCT00124878

HIV Infections Sexually Transmitted Diseases Papillomavirus Infections +5 more

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gender Affirmation Surgery Perioperative Care Transgender Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

STRIVE Peer Support Intervention

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

Group Type EXPERIMENTAL

STRIVE Peer Support Intervention

Intervention Type OTHER

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

Enhanced Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

STRIVE Peer Support Intervention

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No