Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT04154358
Status:
UNKNOWN
Last Update Posted:
2020-03-23
First Post:
2019-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-07-11', 'releaseDate': '2024-01-29'}], 'estimatedResultsFirstSubmitDate': '2024-01-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014189', 'term': 'Transsexualism'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of cervical cancer screening', 'timeFrame': '1 year', 'description': 'Evaluate whether implementation of HPV DNA self swabs will increase rates of cervical cancer screening among transgender men by percentage of trans men who obtain screening through the study'}], 'secondaryOutcomes': [{'measure': 'incidence of barriers to care', 'timeFrame': '1 year', 'description': 'Determine which barriers contribute most to lack of cervical cancer screening among transgender men. Measured via survey.'}, {'measure': 'incidence of high risk sexual practices', 'timeFrame': '1 year', 'description': 'Evaluate for the presence of high risk behaviors to determine whether transgender men in our population are at higher or lower risk for HPV-related cervical dysplasia. Measured via survey.'}, {'measure': 'rate of HPV vaccination', 'timeFrame': '1 year', 'description': 'Evaluate percentage of transgender men that have been vaccinated for HPV. Measured via survey.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transgenderism', 'Cervical Cancer', 'Human Papilloma Virus']}, 'descriptionModule': {'briefSummary': 'Transgender men are individuals born genetically female that have a gender identity that is incongruent with their biological sex. For those who have begun or completed transition, they may present as males but still have a uterus and cervix. Thus far, no distinction has been made between routine cervical cancer screening guidelines in non-transgender women and those for transgender men, despite wide variations in sexual practices, including lifelong vaginal abstinence. The purpose of this study is to offer transgender men seen at clinic visits self-collected HPV testing to evaluate for improved cervical cancer screening rates, as well as a survey to further investigate sexual practices, rates of appropriate screening prior to being offered self-collection, and barriers to obtaining appropriate care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'Must be transgender masculine identifying with uterus and cervix.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>21 for survey and age\\> 25 for HPV testing\n* Transgender male or gender non-conforming identity\n* Female sex at birth\n* Consent to participate in the study\n\nExclusion Criteria:\n\n* impaired decision making capacity\n* Absence of cervix\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT04154358', 'briefTitle': 'Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men', 'orgStudyIdInfo': {'id': '1410051-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HPV Testing', 'description': 'Will perform HPV testing with self-collected specimen', 'interventionNames': ['Diagnostic Test: HPV testing']}], 'interventions': [{'name': 'HPV testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'will perform HPV testing with self-collected specimen', 'armGroupLabels': ['HPV Testing']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Equality Clinic of Augusta', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-01-29', 'type': 'RELEASE'}, {'date': '2024-07-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Augusta University'}}}}