- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06615401
Understanding Perceived Access and Receipt of Gender-affirming Treatments Among Transgender Veterans
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Bedford, Massachusetts, United States, 01730-1114
- VA Bedford HealthCare System, Bedford, MA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Receipt of Gender Affirming Treatment
Time Frame: About 3.5 months
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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.
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About 3.5 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Guneet K. Jasuja, PhD, VA Bedford HealthCare System, Bedford, MA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 22-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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