- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05927350
Research Participation With Transgender and Gender-Diverse Youth
February 17, 2026 updated by: Virginia Commonwealth University
Research has historically excluded the participation of transgender and gender-diverse people.
The purpose of this research study is to find out about what goes into a transgender and gender-diverse youth's decision to participate in research.
The results of this study will be used to improve access to research for transgender and gender-diverse youth and therefore, improve the representation of transgender and gender-diverse youth as research participants in research.
Study Overview
Study Type
Observational
Enrollment (Estimated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: An Pham, MD
- Phone Number: 804-628-5880
- Email: an.pham@vcuhealth.org
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University
-
Contact:
- An Pham
- Phone Number: 804-828-2467
- Email: an.pham@vcuhealth.org
-
Principal Investigator:
- An Pham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Transgender and gender-diverse adolescents
Description
Inclusion Criteria:
- Gender identity different then sex assigned at birth
- Between the ages 15-21 years
Exclusion Criteria:
- Gender identity the same as their sex assigned at birth
- Younger than 15 years of age, and older than 21 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Survey
Participants will complete a one-time survey asking about sociodemographics, pediatric research participation, experience with research, gender minority stress and resilience, vaccine hesitancy, medical mistrust, and connectedness to the LGBT community
|
Survey asking about sociodemographics, pediatric research participation, experience with research, gender minority stress and resilience, vaccine hesitancy, medical mistrust, and connectedness to the LGBT community
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantitative Assessment of Pediatric Research Participation in Transgender Youth
Time Frame: through study completion, estimated to be 3 months
|
The outcome will be the responses (agree or disagree) to the different items in the Pediatric Research Participation measure.
|
through study completion, estimated to be 3 months
|
|
Qualitative Assessment of Pediatric Research Participation in Transgender Youth
Time Frame: through study completion, estimated to be 3 months
|
The investigators will implement qualitative analysis to explore transgender and gender-diverse youths experiences with research, and barriers and facilitators to participating in research.
Specifically, the outcomes will be themes and supporting quotes.
|
through study completion, estimated to be 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: An Pham, MD, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
June 2, 2023
First Submitted That Met QC Criteria
June 21, 2023
First Posted (Actual)
July 3, 2023
Study Record Updates
Last Update Posted (Actual)
February 20, 2026
Last Update Submitted That Met QC Criteria
February 17, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20026635
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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