Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-02 @ 4:49 AM
Study NCT ID:
NCT05419232
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2022-06-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COVID-19 Vaccine Uptake Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072758', 'term': 'Vaccination Refusal'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D016312', 'term': 'Treatment Refusal'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013097', 'term': 'Spermine Synthase'}], 'ancestors': [{'id': 'D019883', 'term': 'Alkyl and Aryl Transferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jason.newland@nationwidechildrens.org', 'phone': '6147223416', 'title': 'Jason Newland', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Call + Call', 'description': 'Participants were randomized to Call at timepoint one and Call at timepoint two', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: Call + Text', 'description': 'Participants were randomized to Call at timepoint one and Text at timepoint two.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3: Text + Call', 'description': 'Participants were randomized to Text at timepoint one and Call at timepoint two.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group 4: Text + Text', 'description': 'Participants were randomized to Text at timepoint one and Text at timepoint two.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 0, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group 5: Call Only', 'description': 'Participants were randomized to Call at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Group 6: Text Only', 'description': 'Participants were randomized to Text at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Vaccine Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Call + Call', 'description': 'Participants were randomized to Call at timepoint one and Call at timepoint two'}, {'id': 'OG001', 'title': 'Group 2: Call + Text', 'description': 'Participants were randomized to Call at timepoint one and Text at timepoint two.'}, {'id': 'OG002', 'title': 'Group 3: Text + Call', 'description': 'Participants were randomized to Text at timepoint one and Call at timepoint two.'}, {'id': 'OG003', 'title': 'Group 4: Text + Text', 'description': 'Participants were randomized to Text at timepoint one and Text at timepoint two.'}, {'id': 'OG004', 'title': 'Group 5: Call Only', 'description': 'Participants were randomized to Call at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.'}, {'id': 'OG005', 'title': 'Group 6: Text Only', 'description': 'Participants were randomized to Text at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 weeks', 'description': 'The primary outcome of this study will be the percentage of individuals who received any COVID-19 vaccination within two weeks of a study intervention. Vaccine uptake will be primarily assessed by verbal confirmation of recent vaccination during a follow-up visit with a study team member.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vaccinated or Indicated They Would Receive Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Call + Call', 'description': 'Participants were randomized to Call at timepoint one and Call at timepoint two'}, {'id': 'OG001', 'title': 'Group 2: Call + Text', 'description': 'Participants were randomized to Call at timepoint one and Text at timepoint two.'}, {'id': 'OG002', 'title': 'Group 3: Text + Call', 'description': 'Participants were randomized to Text at timepoint one and Call at timepoint two.'}, {'id': 'OG003', 'title': 'Group 4: Text + Text', 'description': 'Participants were randomized to Text at timepoint one and Text at timepoint two.'}, {'id': 'OG004', 'title': 'Group 5: Call Only', 'description': 'Participants were randomized to Call at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.'}, {'id': 'OG005', 'title': 'Group 6: Text Only', 'description': 'Participants were randomized to Text at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 weeks', 'description': 'The primary outcome of this study will be the percentage of individuals who received any COVID-19 vaccination or indicated they would receive any COVID-19 vaccination within two weeks of a study intervention. Vaccine uptake will be primarily assessed by verbal confirmation of recent vaccination during a follow-up visit with a study team member.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Call + Call', 'description': 'Participants were randomized to Call at timepoint one and Call at timepoint two'}, {'id': 'FG001', 'title': 'Group 2: Call + Text', 'description': 'Participants were randomized to Call at timepoint one and Text at timepoint two.'}, {'id': 'FG002', 'title': 'Group 3: Text + Call', 'description': 'Participants were randomized to Text at timepoint one and Call at timepoint two.'}, {'id': 'FG003', 'title': 'Group 4: Text + Text', 'description': 'Participants were randomized to Text at timepoint one and Text at timepoint two.'}, {'id': 'FG004', 'title': 'Group 5: Call Only', 'description': 'Participants were randomized to Call at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.'}, {'id': 'FG005', 'title': 'Group 6: Text Only', 'description': 'Participants were randomized to Text at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '71'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '71'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Individuals were recruited from previous COVID-19 testing studies. Individuals were eligible for the study if they were an employee, student, or a family member of a student or employees from nine school districts and charter schools in St. Louis or if they were a resident of St. Louis City or County and were completely unvaccinated for COVID-19. Eligibility expanded to include individuals that were not up to date for their COVID-19 vaccine.', 'preAssignmentDetails': '1558 families were called for recruitment, 666 families were screened, 262 individuals were consented, 251 participants received first randomization'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '251', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Call + Call', 'description': 'Participants were randomized to Call at timepoint one and Call at timepoint two'}, {'id': 'BG001', 'title': 'Group 2: Call + Text', 'description': 'Participants were randomized to Call at timepoint one and Text at timepoint two.'}, {'id': 'BG002', 'title': 'Group 3: Text + Call', 'description': 'Participants were randomized to Text at timepoint one and Call at timepoint two.'}, {'id': 'BG003', 'title': 'Group 4: Text + Text', 'description': 'Participants were randomized to Text at timepoint one and Text at timepoint two.'}, {'id': 'BG004', 'title': 'Group 5: Call Only', 'description': 'Participants were randomized to Call at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.'}, {'id': 'BG005', 'title': 'Group 6: Text Only', 'description': 'Participants were randomized to Text at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000', 'lowerLimit': '14', 'upperLimit': '47'}, {'value': '21', 'groupId': 'BG001', 'lowerLimit': '13', 'upperLimit': '43'}, {'value': '39', 'groupId': 'BG002', 'lowerLimit': '14', 'upperLimit': '49'}, {'value': '30', 'groupId': 'BG003', 'lowerLimit': '13', 'upperLimit': '44'}, {'value': '47', 'groupId': 'BG004', 'lowerLimit': '18.75', 'upperLimit': '53.5'}, {'value': '35', 'groupId': 'BG005', 'lowerLimit': '34', 'upperLimit': '51'}, {'value': '35', 'groupId': 'BG006', 'lowerLimit': '14', 'upperLimit': '46'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '169', 'groupId': 'BG006'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '81', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '233', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '135', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '92', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Received COVID-19 Vaccine', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '114', 'groupId': 'BG006'}]}, {'title': 'No', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '137', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Participant's COVID-19 Vaccine Status at Enrollment", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-06', 'size': 601508, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-27T16:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2022-06-11', 'resultsFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2022-06-11', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-04', 'studyFirstPostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaccine Uptake', 'timeFrame': 'Up to 8 weeks', 'description': 'The primary outcome of this study will be the percentage of individuals who received any COVID-19 vaccination within two weeks of a study intervention. Vaccine uptake will be primarily assessed by verbal confirmation of recent vaccination during a follow-up visit with a study team member.'}], 'secondaryOutcomes': [{'measure': 'Vaccinated or Indicated They Would Receive Vaccine', 'timeFrame': 'Up to 8 weeks', 'description': 'The primary outcome of this study will be the percentage of individuals who received any COVID-19 vaccination or indicated they would receive any COVID-19 vaccination within two weeks of a study intervention. Vaccine uptake will be primarily assessed by verbal confirmation of recent vaccination during a follow-up visit with a study team member.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaccination Refusal', 'COVID-19']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention. COVID-19; 2022, https://www.cdc.gov/coronavirus/2019-ncov/index.html. Accessed March 1, 2022.'}, {'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention. COVID-19 Mortality Overview. 2022; https://www.cdc.gov/nchs/covid19/mortality-overview.htm. Accessed March 1, 2022'}, {'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention. COVID-19; 2022, https://www.cdc.gov/mmwr/volumes/71/wr/mm7101a4.htm#:~:text=COVID%2D19%20vaccines%20are%20highly,death%20(0.0033%25)%20were%20rare., Accessed March 1, 2022'}, {'pmid': '33926993', 'type': 'BACKGROUND', 'citation': "Milkman KL, Patel MS, Gandhi L, Graci HN, Gromet DM, Ho H, Kay JS, Lee TW, Akinola M, Beshears J, Bogard JE, Buttenheim A, Chabris CF, Chapman GB, Choi JJ, Dai H, Fox CR, Goren A, Hilchey MD, Hmurovic J, John LK, Karlan D, Kim M, Laibson D, Lamberton C, Madrian BC, Meyer MN, Modanu M, Nam J, Rogers T, Rondina R, Saccardo S, Shermohammed M, Soman D, Sparks J, Warren C, Weber M, Berman R, Evans CN, Snider CK, Tsukayama E, Van den Bulte C, Volpp KG, Duckworth AL. A megastudy of text-based nudges encouraging patients to get vaccinated at an upcoming doctor's appointment. Proc Natl Acad Sci U S A. 2021 May 18;118(20):e2101165118. doi: 10.1073/pnas.2101165118."}, {'pmid': '21812168', 'type': 'BACKGROUND', 'citation': 'Humiston SG, Bennett NM, Long C, Eberly S, Arvelo L, Stankaitis J, Szilagyi PG. Increasing inner-city adult influenza vaccination rates: a randomized controlled trial. Public Health Rep. 2011 Jul-Aug;126 Suppl 2(Suppl 2):39-47. doi: 10.1177/00333549111260S206.'}, {'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention. Immunization Strategies for Healthcare Practices and Providers. 2021; https://www.cdc.gov/vaccines/pubs/pinkbook/strat.html . Accessed April 11, 2022'}, {'pmid': '35248000', 'type': 'BACKGROUND', 'citation': "Morales-Campos DY, Flores BE, Donovan E, Burdick S, Parra-Medina D, Kahn JA. A qualitative descriptive study of providers' perspectives on human papillomavirus vaccine administration among Latino/a adolescents in South Texas clinics: barriers and facilitators. BMC Public Health. 2022 Mar 5;22(1):443. doi: 10.1186/s12889-022-12837-2."}, {'pmid': '30867173', 'type': 'BACKGROUND', 'citation': 'Shen SC, Dubey V. Addressing vaccine hesitancy: Clinical guidance for primary care physicians working with parents. Can Fam Physician. 2019 Mar;65(3):175-181.'}, {'pmid': '31764255', 'type': 'BACKGROUND', 'citation': 'Mehrotra ML, Petersen ML, Geng EH. Understanding HIV Program Effects: A Structural Approach to Context Using the Transportability Framework. J Acquir Immune Defic Syndr. 2019 Dec;82 Suppl 3(Suppl 3):S199-S205. doi: 10.1097/QAI.0000000000002202.'}, {'type': 'BACKGROUND', 'citation': 'Pearl, J., and E. Bareinboim. External Validity: From Do-Calculus to Transportability Across Populations. Statistical Science. 2014; 29:579-595'}, {'pmid': '34340242', 'type': 'BACKGROUND', 'citation': 'Dai H, Saccardo S, Han MA, Roh L, Raja N, Vangala S, Modi H, Pandya S, Sloyan M, Croymans DM. Behavioural nudges increase COVID-19 vaccinations. Nature. 2021 Sep;597(7876):404-409. doi: 10.1038/s41586-021-03843-2. Epub 2021 Aug 2.'}, {'pmid': '25264466', 'type': 'BACKGROUND', 'citation': 'Almirall D, Nahum-Shani I, Sherwood NE, Murphy SA. Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research. Transl Behav Med. 2014 Sep;4(3):260-74. doi: 10.1007/s13142-014-0265-0.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to assess the best COVID-19 vaccine uptake strategy among students, staff and household members that have not been vaccinated.\n\nThere is a multitude of recommendations present that highlight different vaccination strategy; however, it is still unclear which strategy is best to increase COVID-19 vaccination rates. We will compare the effectiveness and acceptance of two different communication strategies among unvaccinated students, staff, and their household members.', 'detailedDescription': "A sequential multiple assignment randomized trial (SMART) will be conducted to assess two strategies to increase COVID-19 vaccine uptake. The two strategies that will be assessed are a text message with a link to an information website and peer-based motivational interview. If individuals do not seek vaccination after the first intervention, they will again be randomized into the same two interventions. This will allow for testing of both interventions as well as understanding if the use of a more intense intervention (two 'doses') is optimal for vaccine uptake.\n\nIn addition, SARS-CoV-2 saliva-based testing will be conducted among students, staff, and household members from the summer of 2022 through the first semester of the 2022-2023 school year. As the pandemic is in its third year, the use of testing among students, staff, and their household members will be assessed Individuals are eligible to be tested multiple times and the testing will occur along different timelines."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Is not up to date with their COVID-19 vaccinations per CDC guidelines\n2. is considered eligible by the CDC at the time of enrollment to receive a COVID-19 vaccine\n3. is a staff, student, or household member of staff or student of one of the participating school districts OR a resident of St. Louis City or St. Louis County\n\nExclusion Criteria:\n\n1. Is currently up to date with their COVID-19 vaccinations per CDC guidelines\n2. ineligible to receive any COVID-19 vaccine due to medical history or age\n3. is not a staff or student, or household member of staff or student of one of the participating school districts AND is not a resident of St. Louis City or St. Louis County\n4. participant (or their parents/LAR) do not provide consent.'}, 'identificationModule': {'nctId': 'NCT05419232', 'briefTitle': 'COVID-19 Vaccine Uptake Trial', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'RADx Up Safe Return to Schools: Strategies to Increase Vaccine Uptake', 'orgStudyIdInfo': {'id': '202204166'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Short Message Service (SMS) with an associated link to a multi-media website', 'description': 'The participant will receive a SMS with a brief message containing the following: (1) statement encouraging them to get vaccinated and (2) a link to a multi-media page with videos and additional resources encouraging individuals to be vaccinated. The multi-media website will be housed in the Safe Return To School website and updated by a designated study team members. This page will include the following COVID-19-related resources: publicly available vaccine promotion videos, videos consisting of community members discussing vaccine topics, resources regarding local vaccine sites, and links to additional literature resources.', 'interventionNames': ['Other: Short Message Service (SMS) + Website Link Strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phone Call with Peer', 'description': "The participant's peer will be a study team member who has the same or similar racial demographic as the participant. All team members conducting the peer phone calls will be trained in motivational interviewing. The participant will be called by their peer via zoom or phone. Motivational interviewing techniques will be utilized with the participant to promote vaccine uptake. The team member will use a facilitator guide throughout the peer intervention.", 'interventionNames': ['Other: Phone Call with Peer Strategy']}], 'interventions': [{'name': 'Short Message Service (SMS) + Website Link Strategy', 'type': 'OTHER', 'description': 'The intervention we are evaluating is the effectiveness of a participant receiving a SMS + Website Link as a vaccine uptake strategy', 'armGroupLabels': ['Short Message Service (SMS) with an associated link to a multi-media website']}, {'name': 'Phone Call with Peer Strategy', 'type': 'OTHER', 'description': 'The intervention we are evaluating is the effectiveness of a participant having a phone call with a peer as a vaccine uptake strategy', 'armGroupLabels': ['Phone Call with Peer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63042', 'city': 'Hazelwood', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ferguson-Florissant School District', 'geoPoint': {'lat': 38.77144, 'lon': -90.37095}}, {'zip': '63136', 'city': 'Jennings', 'state': 'Missouri', 'country': 'United States', 'facility': 'Jennings School District', 'geoPoint': {'lat': 38.71922, 'lon': -90.26039}}, {'zip': '63074', 'city': 'Saint Ann', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pattonville School District', 'geoPoint': {'lat': 38.72727, 'lon': -90.38317}}, {'zip': '63103', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Language Immersion School', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63114', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ritenour School District', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63121', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Normandy Schools Collaborative', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63144', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Maplewood Richmond Heights School District', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63130', 'city': 'University City', 'state': 'Missouri', 'country': 'United States', 'facility': 'University City School District', 'geoPoint': {'lat': 38.65588, 'lon': -90.30928}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}