Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-11 @ 12:13 AM
Study NCT ID:
NCT01526551
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2011-12-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Compare the Impact of a School Based HPV Program on Vaccination Uptake and Completion Rates
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053918', 'term': 'Papillomavirus Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robin@kcr.uky.edu', 'phone': '859-218-2102', 'title': 'Dr. Robin Vanderpool', 'organization': 'University of Kentucky College of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'August 2012-June 2013', 'description': 'Staff developed and implemented a protocol that allowed for documentation of adverse vaccine reactions among all vaccine-receiving students.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention School', 'description': 'High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic\n\nHPV Vaccine and Disease Education: Increased education of disease and vaccine\n\nReduction of barriers: eliminate barriers to being vaccinated', 'otherNumAtRisk': 511, 'otherNumAffected': 0, 'seriousNumAtRisk': 511, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention School', 'description': 'High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic\n\nHPV Vaccine and Disease Education: Increased education of disease and vaccine\n\nReduction of barriers: eliminate barriers to being vaccinated'}], 'classes': [{'categories': [{'measurements': [{'value': '315', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'August 2012-June 2013', 'description': 'Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Students Who Completed HPV Vaccination as a Result of the School-based Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention School', 'description': 'High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic\n\nHPV Vaccine and Disease Education: Increased education of disease and vaccine\n\nReduction of barriers: eliminate barriers to being vaccinated'}], 'classes': [{'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'August 2012 -- June 2013', 'description': 'Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention School', 'description': 'High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic\n\nHPV Vaccine and Disease Education: Increased education of disease and vaccine\n\nReduction of barriers: eliminate barriers to being vaccinated'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '935'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '511'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '424'}]}], 'dropWithdraws': [{'type': 'Lack of returned parental consent form', 'reasons': [{'groupId': 'FG000', 'numSubjects': '424'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention School', 'description': 'High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic\n\nHPV Vaccine and Disease Education: Increased education of disease and vaccine\n\nReduction of barriers: eliminate barriers to being vaccinated'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Ages 12-20', 'categories': [{'measurements': [{'value': '511', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '240', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '271', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Grade', 'classes': [{'title': '9th grade', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}]}]}, {'title': '10th grade', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}]}]}, {'title': '11th grade', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}]}]}, {'title': '12th grade', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Insurance Status', 'classes': [{'title': 'Insured', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}]}]}, {'title': 'Medicaid/KCHIP', 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}]}]}, {'title': 'No Insurance', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Underinsured', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior doses (baseline)', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '447', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 935}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-19', 'studyFirstSubmitDate': '2011-12-22', 'resultsFirstSubmitDate': '2015-02-19', 'studyFirstSubmitQcDate': '2012-02-03', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-19', 'studyFirstPostDateStruct': {'date': '2012-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program', 'timeFrame': 'August 2012-June 2013', 'description': 'Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program'}, {'measure': 'Number of Students Who Completed HPV Vaccination as a Result of the School-based Program', 'timeFrame': 'August 2012 -- June 2013', 'description': 'Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Human Papillomavirus'], 'conditions': ['Human Papillomavirus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of a school-based Human Papillomavirus (HPV) vaccination program to determine if the combination of increased disease and vaccine education coupled with the removal of barriers will positively impact the HPV vaccination uptake and completion rates among students.', 'detailedDescription': 'The purpose of this study is to evaluate the impact of a school-based HPV vaccination program. The intervention will consists of: provision of HPV vaccine information and consent forms for parents delivered in the back-to-school packets; school-nurse delivered student education; removal of barriers (scheduling, transportation and parental presence); changing of social norms; and the provision of free HPV vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have not completed three dose series of HPV vaccine\n* Must be a student at Wayne County or Monticello High School in KY\n\nExclusion Criteria:\n\n* Completed three dose series\n* Pregnant\n* Contraindication to vaccine ingredients'}, 'identificationModule': {'nctId': 'NCT01526551', 'briefTitle': 'A Study to Compare the Impact of a School Based HPV Program on Vaccination Uptake and Completion Rates', 'organization': {'class': 'OTHER', 'fullName': 'Lake Cumberland District Health Department'}, 'officialTitle': 'A Study to Compare the Impact of a School Based HPV Vaccination Program on Vaccination Uptake and Completion Rates Among High School Students in Rural, Southeastern Kentucky', 'orgStudyIdInfo': {'id': 'LCDHD-12-HPV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Schools', 'description': 'High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV Vaccine and HPV-related Health Education and Reduction of barriers to being vaccinated.', 'interventionNames': ['Other: HPV Vaccine and HPV-related Health Education', 'Other: Reduction of barriers']}], 'interventions': [{'name': 'HPV Vaccine and HPV-related Health Education', 'type': 'OTHER', 'description': 'Increased education of HPV-related diseases and HPV vaccine', 'armGroupLabels': ['Intervention Schools']}, {'name': 'Reduction of barriers', 'type': 'OTHER', 'otherNames': ['School based delivery of HPV vaccine'], 'description': 'Eliminate structural and financial barriers to being vaccinated', 'armGroupLabels': ['Intervention Schools']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42633', 'city': 'Monticello', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Monticello High School', 'geoPoint': {'lat': 36.82979, 'lon': -84.84911}}, {'zip': '42633', 'city': 'Monticello', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Wayne County High School', 'geoPoint': {'lat': 36.82979, 'lon': -84.84911}}], 'overallOfficials': [{'name': 'Christine Weyman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lake Cumberland District Health Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lake Cumberland District Health Department', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}