Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-26 @ 8:43 AM
Study NCT ID:
NCT05927350
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2023-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research Participation With Transgender and Gender-Diverse Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2023-06-02', 'studyFirstSubmitQcDate': '2023-06-21', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative Assessment of Pediatric Research Participation in Transgender Youth', 'timeFrame': 'through study completion, estimated to be 3 months', 'description': 'The outcome will be the responses (agree or disagree) to the different items in the Pediatric Research Participation measure.'}, {'measure': 'Qualitative Assessment of Pediatric Research Participation in Transgender Youth', 'timeFrame': 'through study completion, estimated to be 3 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transgender Persons']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '15 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Transgender and gender-diverse adolescents', 'genderDescription': 'Gender identity different then sex assigned at birth and ages 15-21 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gender identity different then sex assigned at birth\n* Between the ages 15-21 years\n\nExclusion Criteria:\n\n* Gender identity the same as their sex assigned at birth\n* Younger than 15 years of age, and older than 21 years of age'}, 'identificationModule': {'nctId': 'NCT05927350', 'briefTitle': 'Research Participation With Transgender and Gender-Diverse Youth', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Research Participation With Transgender and Gender-Diverse Youth', 'orgStudyIdInfo': {'id': 'HM20026635'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survey', 'description': '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', 'interventionNames': ['Other: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Survey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'An Pham', 'role': 'CONTACT', 'email': 'an.pham@vcuhealth.org', 'phone': '804-828-2467'}, {'name': 'An Pham', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'centralContacts': [{'name': 'An Pham, MD', 'role': 'CONTACT', 'email': 'an.pham@vcuhealth.org', 'phone': '804-628-5880'}], 'overallOfficials': [{'name': 'An Pham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}