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Gender DysphoriaNCT06615401

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

An observational study of Gender Dysphoria, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Gender Dysphoria
How many people
986 participants
Where
1 siteUnited States
Study dates
1 Oct 2024to 18 Jan 2025
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Transgender and gender diverse veterans as identified by documentation of gender identity disorder diagnoses, self-identified gender identity and transgender-related health factors.

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Bedford HealthCare System, Bedford, MA

    Bedford, Massachusetts, 01730-1114

Other trials in United States

About this study

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.

Read the detailed description

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.

Keywords
transgender, gender dysphoria, gender-affirming treatment
Medical subject headings
Gender Dysphoria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06615401
Study groupRoleWhat they receive
Transgender and Gender Diverse VeteransVeterans with documentation of either a gender identity disorder diagnoses, self-identified gender identity as transgender and gender diverse or transgender-related health factor.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Receipt of Gender Affirming Treatment

    Through a national survey, the investigators will identify receipt of gender-affirming treatment in VA and VA Community Care among transgender and gender diverse Veterans.

    Measured: About 3.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2024
  2. Study start1 Oct 2024
  3. Primary completion18 Jan 2025
  4. Study completion18 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
986 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06615401
Sponsor's protocol ID
IIR 22-201
Status last verified
Jan 2026
First submitted
23 Sep 2024
Last updated
28 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jasuja GK, Zocchi MS, Reisman JI, Brady JE, Livingston NA, Blosnich JR, Vimalananda VG, Singh RS, Goodman M, Silverberg MJ, Wormwood JB, Shipherd JC. Using Self-Identified Gender Identity Data to Advance Health Equity Among Transgender and Gender Diverse Veterans in the Veterans Health Administration. Med Care. 2025 Nov 1;63(11):833-841. doi: 10.1097/MLR.0000000000002195. Epub 2025 Sep 26.

    PubMed 41001883

Questions about this trial

What is this clinical trial studying?

An observational study of Gender Dysphoria, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Receipt of Gender Affirming Treatment (time frame: About 3.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06615401, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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