NCT05927350

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2025Jun 2026

First Submitted

Initial submission to the registry

June 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 29, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

June 2, 2023

Last Update Submit

February 17, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Quantitative Assessment of Pediatric Research Participation in Transgender Youth

    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

    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

Study Arms (1)

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

Other: Survey

Interventions

SurveyOTHER

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

Eligibility Criteria

Age15 Years - 21 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGender identity different then sex assigned at birth and ages 15-21 years
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Transgender and gender-diverse adolescents

You may qualify if:

  • Gender identity different then sex assigned at birth
  • Between the ages 15-21 years

You may not qualify if:

  • Gender identity the same as their sex assigned at birth
  • Younger than 15 years of age, and older than 21 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • An Pham, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2023

First Posted

July 3, 2023

Study Start

January 29, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations