Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-21 @ 12:37 PM
Study NCT ID:
NCT03709602
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2018-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SDH of HPV Vaccine Completion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lisa.mansfield@duke.edu', 'phone': '919-681-9198', 'title': 'Dr. Lisa Mansfield', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Participants in the Cohort of Adolescents From EHR group were not monitored/assessed for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Adolescents Ages 11 to 14 Years', 'description': 'Adolescents ages 11 to 14 years who have received 1 dose of the HPV vaccine series between January 2017 and December 2017. Adolescents were stratified into two groups: Completer (defined as adolescents who received two vaccine doses within a 14-month period) and Non-Completer (defined as adolescents who did not receive two vaccine doses).', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Parent of Adolescents', 'description': "Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian, and who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent. Parents were stratified into two groups (Completer or Non-Completer as described in the adolescent group) based on the adolescent's vaccination status.", 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall HPV Vaccine Completion Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort of Adolescents From Electronic Health Record (EHR)', 'description': "A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period."}], 'classes': [{'categories': [{'title': 'Completers', 'measurements': [{'value': '1961', 'groupId': 'OG000'}]}, {'title': 'Non-Completers', 'measurements': [{'value': '1083', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 14 months', 'description': "Adolescents who completed the required HPV vaccine doses (e.g. two or three doses based on the CDC's vaccine administration guidelines for adolescents' ages 11 to 14 years) during the January 2017 to February 2019 observation period.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccine completion rates were only analyzed for the quantitative sample of adolescents using the EHR data (N=3044).'}, {'type': 'SECONDARY', 'title': 'HPV Vaccine Completion Within 14-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort of Adolescents From EHR', 'description': "A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period."}], 'classes': [{'categories': [{'measurements': [{'value': '1637', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 14 months', 'description': "Adolescents who received the required number of doses for vaccine completion, defined as the receipt of two or three doses based on the CDC's guidelines for adolescents' ages 11 to 14 years, within 14-months from their first vaccine dose.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccine completion rates were only analyzed for the quantitative sample of adolescents using the EHR data (N=3044).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adolescents Ages 11 to 14 Years', 'description': 'Adolescents ages 11 to 14 years who have received 1 dose of the HPV vaccine series between January 2017 and December 2017. Adolescents were stratified into two groups: Completer (defined as adolescents who received two vaccine doses within a 14-month period) and Non-Completer (defined as adolescents who received only one vaccine dose within 14-month period). Qualitative sample.'}, {'id': 'FG001', 'title': 'Parent of Adolescents', 'description': "Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian, and who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent. Parents were stratified into two groups (Completer or Non-Completer as described in the adolescent group) based on the adolescent's vaccination status. Qualitative sample."}, {'id': 'FG002', 'title': 'Cohort of Adolescents From Electronic Health Record (EHR)', 'description': "A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period. Quantitative sample."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Adolescents recruited for qualitative interviews.', 'groupId': 'FG000', 'numSubjects': '16'}, {'comment': 'Parents recruited for qualitative interviews.', 'groupId': 'FG001', 'numSubjects': '16'}, {'comment': 'Cohort of adolescents created from the EHR data for the quantitative portion of the study.', 'groupId': 'FG002', 'numSubjects': '3044'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Adolescents recruited for qualitative interviews.', 'groupId': 'FG000', 'numSubjects': '16'}, {'comment': 'Parents recruited for qualitative interviews.', 'groupId': 'FG001', 'numSubjects': '16'}, {'comment': 'Cohort of adolescents created from the EHR data for the quantitative portion of the study.', 'groupId': 'FG002', 'numSubjects': '3044'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '32 participants were recruited for the qualitative portion of the study to participate in interviews (n = 16 parents, n = 16 adolescents)', 'preAssignmentDetails': 'Cohort of Adolescents from electronic health record group were reviewed retrospectively from January 1, 2017- February 28, 2019. Enrollment of parents and adolescents (n = 32) began on the start date of January 7, 2019.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '3044', 'groupId': 'BG002'}, {'value': '3076', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Adolescents Ages 11 to 14 Years', 'description': 'Adolescents ages 11 to 14 years who have received 1 dose of the HPV vaccine series between January 2017 and December 2017. Adolescents were stratified into two groups: Completer (defined as adolescents who received two vaccine doses within a 14-month period) and Non-Completer (defined as adolescents who did not receive two vaccine doses). Qualitative sample.'}, {'id': 'BG001', 'title': 'Parent of Adolescents', 'description': "Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian, and who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent. Parents were stratified into two groups (Completer or Non-Completer as described in the adolescent group) based on the adolescent's vaccination status. Qualitative sample."}, {'id': 'BG002', 'title': 'Cohort of Adolescents From Electronic Health Record (EHR)', 'description': "A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period. Quantitative sample."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3044', 'groupId': 'BG002'}, {'value': '3060', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000', 'lowerLimit': '11', 'upperLimit': '14'}, {'value': '43', 'groupId': 'BG001', 'lowerLimit': '29', 'upperLimit': '67'}, {'value': '12.1', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '14'}, {'value': 'NA', 'comment': 'The mean age for the participant sample of parents for the qualitative interviews were analyzed separately from the cohort of adolescent group using the EHR dataset, since parents were not included in the quantitative dataset.', 'groupId': 'BG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '1492', 'groupId': 'BG002'}, {'value': '1517', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1552', 'groupId': 'BG002'}, {'value': '1559', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '2653', 'groupId': 'BG002'}, {'value': '2675', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Non Hispanic Black or African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '965', 'groupId': 'BG002'}, {'value': '976', 'groupId': 'BG003'}]}]}, {'title': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1441', 'groupId': 'BG002'}, {'value': '1449', 'groupId': 'BG003'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Non-Hispanic Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '3044', 'groupId': 'BG002'}, {'value': '3076', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HPV vaccine completion status', 'classes': [{'categories': [{'title': 'Completers', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1961', 'groupId': 'BG002'}, {'value': '1977', 'groupId': 'BG003'}]}, {'title': 'Non-Completers', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1083', 'groupId': 'BG002'}, {'value': '1099', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Completer defined as receiving 2 or 3 vaccine doses within 14-month period determined by the CDC's vaccine administration schedule. Non-completer defined as receiving only 1 vaccine dose within 14-month period.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'There is no quantitative results beyond demographics for the Adolescents ages 11 to 14 years and parent of adolescents groups as this was not part of the aim of the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-25', 'size': 156500, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-04T12:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3076}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2018-10-15', 'resultsFirstSubmitDate': '2020-06-05', 'studyFirstSubmitQcDate': '2018-10-15', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-18', 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall HPV Vaccine Completion Rates', 'timeFrame': 'up to 14 months', 'description': "Adolescents who completed the required HPV vaccine doses (e.g. two or three doses based on the CDC's vaccine administration guidelines for adolescents' ages 11 to 14 years) during the January 2017 to February 2019 observation period."}], 'secondaryOutcomes': [{'measure': 'HPV Vaccine Completion Within 14-Months', 'timeFrame': 'within 14 months', 'description': "Adolescents who received the required number of doses for vaccine completion, defined as the receipt of two or three doses based on the CDC's guidelines for adolescents' ages 11 to 14 years, within 14-months from their first vaccine dose."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HPV', 'adolescents', 'HPV Vaccine', 'social determinants'], 'conditions': ['Human Papilloma Virus']}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to find out which factors influence parents' ability to complete the human papillomavirus (HPV) vaccine series for their child. The information learned from this study may help the investigators develop programs to improve HPV vaccine completion rates among adolescents and reduce barriers to receiving the second shot of the vaccine series."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents ages 11 to 14 years and their parent from Duke University Primary Care Pediatrics at Roxboro Road.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* For adolescents, participants need to be between the ages 11 to 14 years.\n* Received 1 dose of the HPV vaccine series between January 2017 and December 2017.\n* For parents, there is no age limit required.\n* Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian.\n* Parents or legal guardians who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent.\n\nExclusion Criteria:\n\n* Parents with cognitive impairment.\n* Adolescents with cognitive impairment.\n* Adolescents emancipated from their parents or legal guardian\n* Pregnant adolescent girls."}, 'identificationModule': {'nctId': 'NCT03709602', 'briefTitle': 'SDH of HPV Vaccine Completion', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Social Determinants of HPV Vaccine Completion Among Adolescents', 'orgStudyIdInfo': {'id': 'Pro00100733'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adolescents ages 11 to 14 years', 'description': 'Adolescents ages 11 to 14 years who have received 1 dose of the HPV vaccine series between January 2017 and December 2017'}, {'label': 'Parent of adolescents', 'description': "Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian, and who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent."}, {'label': 'Cohort of Adolescents From Electronic Health Record (EHR)', 'description': "A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period."}]}, 'contactsLocationsModule': {'locations': [{'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Primary Care Pediatrics at Roxboro Road', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Rosa Gonzalez-Guarda, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}