Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-28 @ 1:54 AM
Study NCT ID:
NCT04208269
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2019-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5663}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2015-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-15', 'studyFirstSubmitDate': '2019-12-19', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of participants receiving HPV vaccine', 'timeFrame': 'Up to 5 months', 'description': 'The percent age eligible participants who initiate HPV vaccination.'}, {'measure': 'Number of preventive care visits', 'timeFrame': 'Up to 3 months', 'description': 'The percent age eligible participants received a preventive care visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preventative', 'postcard', 'vaccinate'], 'conditions': ['Human Papilloma Virus']}, 'referencesModule': {'references': [{'pmid': '32953426', 'type': 'DERIVED', 'citation': "Staras SAS, Vadaparampil ST, Thompson LA, Scherr C, Gurka MJ, Filipp SL, Shenkman EA. Postcard reminders for HPV vaccination mainly primed parents for providers' recommendations. Prev Med Rep. 2020 Aug 26;20:101188. doi: 10.1016/j.pmedr.2020.101188. eCollection 2020 Dec."}]}, 'descriptionModule': {'briefSummary': 'Our project will assess the feasibility and estimate preliminary efficacy of a multilevel intervention to improve HPV vaccine series initiation among adolescents in Medicaid and CHIP. The investigators will use two intervention components: postcards and an iPad survey system. To estimate efficacy the investigators will select potential participants from Florida Medicaid and CHIP. The investigators will assess their claims for the HPV vaccine before and after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in Florida Medicaid\n* Not initiated the HPV vaccine series at the start of the study period.\n\nExclusion Criteria:\n\n* Anyone who has a severe (life threatening) allergy to any component of HPV vaccine, esp yeast\n* Pregnant\n* Not enrolled in Florida Medicaid'}, 'identificationModule': {'nctId': 'NCT04208269', 'briefTitle': 'A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3', 'orgStudyIdInfo': {'id': 'IRB201200143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Postcard campaign', 'interventionNames': ['Other: postcard campaign']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Provider-only intervention', 'interventionNames': ['Other: Health Information Technology system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patient and provider intervention', 'interventionNames': ['Other: postcard campaign', 'Other: Health Information Technology system']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care'}], 'interventions': [{'name': 'postcard campaign', 'type': 'OTHER', 'description': 'Post card sent to parent only', 'armGroupLabels': ['Patient and provider intervention', 'Postcard campaign']}, {'name': 'Health Information Technology system', 'type': 'OTHER', 'description': 'Accessed by adolescent and provider only', 'armGroupLabels': ['Patient and provider intervention', 'Provider-only intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Stephanie Staras, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}