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Understanding Perceived Access and Receipt of Gender-affirming Treatments Among Transgender Veterans

NCT ID: NCT06615401

Last Updated: 2025-11-14

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

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Recruitment Status

COMPLETED

Total Enrollment

986 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-01-18

Brief Summary

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Transgender Veterans (trans Vets) frequently experience gender dysphoria or distress related to discord between their gender identity and birth sex. Gender-affirming treatments (GATs) are medically necessary treatments to reduce gender dysphoria. However, not much is known about the barriers and facilitators that influence GAT access and receipt in VA and VA Community Care (CC), among trans Vets who desire GATs. The goals of this mixed-methods study are to determine which GATs trans Vets receive and in which setting, identify barriers and facilitators associated with desired GAT receipt in VA and CC, examine association of GAT receipt, specifically mental healthcare and hormone therapy, with mental health and suicide risk and understand trans Vet experiences related to receipt and desire for mental healthcare and hormone therapy in VA and CC.

Detailed Description

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Background: Transgender people experience discord between their gender identity and birth sex, defined as gender dysphoria. Gender-affirming treatments (GATs) are medically necessary treatments to reduce gender dysphoria. However, among transgender Veterans (trans Vets) who desire GATs, not much is known about barriers and facilitators to accessing and receiving GATs in VA and VA Community Care (CC). To ensure effective and equitable GAT access for trans Vets, it is critical to understand: \[1\] GATs trans Vets receive and where they receive them, \[2\] barriers, including social determinants of health (SDOH) barriers that are highly prevalent among trans Vets, and facilitators associated with desired GAT receipt in VA and CC, \[3\] association of GAT receipt, specifically mental healthcare and hormone therapy with mental health and suicide risk , and \[4\] experiences related to receipt of mental healthcare and hormone therapy in VA and CC .

Significance: This study addresses the 2022 HSR\&D priority areas of Access to Care, Health Equity/SDOH, MISSION Act, and research gap of underserved LGBTQ+ Veterans. It is also a high priority for our operational partners in VA LGBTQ+ Health Program, Pharmacy Benefits Management, Office of Integrated Veteran Care, and Office of Mental Health and Suicide Prevention. Knowledge gained from this study will ensure that GAT delivery in the VA is patient-centered and is responsive to the lived realities and needs of trans Vets.

Innovation and Impact: This study will be the first to characterize the GATs received in VA and/or CC to understand how VA and CC are balanced in terms of delivering GATs. This study will also provide novel data on trans Vet experiences related to GAT access in CC and on services and resources used by trans Vets to address barriers that influence GAT access.

Specific Aims: We propose a sequential explanatory mixed method study whose aims are to:

Aim 1. Characterize the GATs received by trans Vets in VA and/or CC (VA/CC) Aim 2. Identify barriers and facilitators associated with desired GAT receipt in VA and CC Aim 3a: Explore association of mental healthcare and hormone with mental health and suicide risk.

Aim 3b. Understand trans Vet experiences related to mental healthcare and hormone therapy in VA and CC.

Methodology: Database Aim 1: We will expand our VA cohort of 9,608 trans Vets (IIR 17-238) from 2006-18 to the data available at the time of funding. We will add CC data to determine the types of GATs received by trans Vets in VA and/or CC. Survey Aim 2: We will survey a national sample of trans Vets identified from Aim 1. Among trans Vets who desire GATs, we will determine SDOH barriers, other barriers, and facilitators associated with desired GAT receipt. Among trans Vets who did not desire GATs, we will determine reasons for not wanting GATs. Aim 3a: Existing survey data from the Aim 2 and linked survey-VA Corporate Data Warehouse will allow robust examination of associations between clinical factors (e.g. co-morbidities), non-clinical factors (e.g. demographics), mental health outcomes (e.g. depression), and suicide risk (e.g. suicide ideation) based on receipt/non-receipt of treatment (mental healthcare, hormone therapy). Aim 3b. Using Aim 2 survey free text responses, we will construct themes related to the experience of trans Vets for mental healthcare and hormone therapy in VA and CC.

Next Steps/Implementation: The proposed study will provide key insights related to the health of trans Vets, while adhering to the new guidance provided within the Forms, Publications, Guidance and Documents Action Team business rules released in April 2025.

Conditions

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Gender Dysphoria

Keywords

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transgender gender dysphoria gender-affirming treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Transgender and Gender Diverse Veterans

Veterans with documentation of either a gender identity disorder diagnoses, self-identified gender identity as transgender and gender diverse or transgender-related health factor.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All veterans with documentation of gender identity disorder diagnoses
* Self-reported gender identity as transgender and relevant transgender-related health factor

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guneet K. Jasuja, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Bedford HealthCare System, Bedford, MA

Locations

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VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IIR 22-201

Identifier Type: -

Identifier Source: org_study_id