Research Participation With Transgender and Gender-Diverse Youth

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05927350
• Collaborator: (none)
• Enrollment: 250
• Anticipated Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transgender Persons	Other: Survey

Study Design

• Study Type: Observational
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Research Participation With Transgender and Gender-Diverse Youth
• Anticipated Study Start Date: Jan 1, 2024
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	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	Other: Survey; 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

Outcome Measures

Primary Outcome Measures

1. Quantitative Assessment of Pediatric Research Participation in Transgender Youth [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.

2. Qualitative Assessment of Pediatric Research Participation in Transgender Youth [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Virginia Commonwealth University

Investigators

• Principal Investigator: An Pham, MD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT05927350
• Other Study ID Numbers: HM20026635
• First Posted: Jul 3, 2023
• Last Update Posted: Jul 3, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 3, 2023