Research Participation With Transgender and Gender-Diverse Youth

Transgender Persons Clinical Trial

Official title:

Research Participation With Transgender and Gender-Diverse Youth

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05927350
• Other study ID #: HM20026635
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: An Pham, MD
• Phone: 804-628-5880
• Email: an.pham[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Transgender Persons

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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