Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 2:06 PM
Study NCT ID:
NCT05150860
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2021-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Communities Fighting COVID Return to School
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rgulizia@sdsu.edu', 'phone': '(619) 594-5938', 'title': 'Assistant Vice President for Research Support Services', 'organization': 'San Diego State University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '21 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'At-home COVID-19 Testing', 'description': 'Weekly COVID-19 screening testing using at-home rapid antigen tests', 'otherNumAtRisk': 264, 'deathsNumAtRisk': 264, 'otherNumAffected': 0, 'seriousNumAtRisk': 264, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Onsite COVID-19 Testing', 'description': 'Weekly COVID-19 screening testing onsite at school with rapid antigen tests', 'otherNumAtRisk': 588, 'deathsNumAtRisk': 588, 'otherNumAffected': 0, 'seriousNumAtRisk': 588, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adherence to the Weekly COVID-19 Testing Schedule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'At-home COVID-19 Testing', 'description': 'Weekly COVID-19 screening testing using at-home rapid antigen tests'}, {'id': 'OG001', 'title': 'Onsite COVID-19 Testing', 'description': 'Weekly COVID-19 screening testing onsite at school with rapid antigen tests'}], 'classes': [{'categories': [{'measurements': [{'value': '0.394', 'spread': '0.038', 'groupId': 'OG000'}, {'value': '0.352', 'spread': '0.032', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, up to 21 weeks', 'description': 'Proportion of scheduled weekly COVID-19 tests completed when enrolled in the trial', 'unitOfMeasure': 'proportion of scheduled tests completed', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Student and school staff participants enrolled in the trial'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'At-home COVID-19 Testing', 'description': 'Weekly COVID-19 screening testing using at-home rapid antigen tests'}, {'id': 'FG001', 'title': 'Onsite COVID-19 Testing', 'description': 'Weekly COVID-19 screening testing onsite at school with rapid antigen tests'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'participants within one school who enrolled in the trial', 'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '264'}, {'comment': 'participants within 2 schools who enrolled in the trial', 'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '588'}]}, {'type': 'Students', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '199'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '500'}]}, {'type': 'School Staff', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '65'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '264'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '588'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'schools', 'recruitmentDetails': 'Trial enrollment of participants occurred from mid-October 2021 through late March 2022, with COVID-19 testing occurring from November 7, 2021 to March 27, 2022; the length of possible trial participation varied from 2 to 21 weeks. Participants were recruited from the three participating middle school populations. All students and school staff at the participating schools were eligible to enroll in the trial.', 'preAssignmentDetails': 'Schools were excluded if they had a lower proportion of students from households receiving SNAP Program benefits and a lower proportion of underrepresented minority students compared with other schools (3 schools); had ongoing school-wide testing programs with a commercial provider (2 schools); had larger (1 school) or smaller (1 school) student populations (for matching purposes) than the remaining schools; or were geographically closer to the remaining schools (1 school).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '588', 'groupId': 'BG001'}, {'value': '852', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'At-home COVID-19 Testing', 'description': 'Weekly COVID-19 screening testing using at-home rapid antigen tests'}, {'id': 'BG001', 'title': 'Onsite COVID-19 Testing', 'description': 'Weekly COVID-19 screening testing onsite at school with rapid antigen tests'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.04', 'spread': '14.18', 'groupId': 'BG000'}, {'value': '17.10', 'spread': '11.55', 'groupId': 'BG001'}, {'value': '18.01', 'spread': '12.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender Identity', 'categories': [{'title': 'Man', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}, {'title': 'Woman', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '325', 'groupId': 'BG001'}, {'value': '490', 'groupId': 'BG002'}]}, {'title': 'Another category (transgender, genderqueer, bigender, agender)', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race and ethnicity', 'categories': [{'title': 'Latinx', 'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '718', 'groupId': 'BG002'}]}, {'title': 'Filipino, Asian, or Asian Pacific Islander', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'African American/Black', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Another race or ethnicity', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Non-Hispanic white', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '588', 'groupId': 'BG001'}, {'value': '852', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary language spoken at home', 'classes': [{'categories': [{'title': 'Spanish', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}, {'title': 'English', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '481', 'groupId': 'BG001'}, {'value': '679', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Student and school staff participants enrolled in the trial'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-08', 'size': 256616, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-09T15:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 852}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2021-12-03', 'resultsFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2021-12-07', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-16', 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to the Weekly COVID-19 Testing Schedule', 'timeFrame': 'through study completion, up to 21 weeks', 'description': 'Proportion of scheduled weekly COVID-19 tests completed when enrolled in the trial'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'availIpds': [{'url': 'https://radx-hub.nih.gov/home', 'type': 'COVID Rapid Acceleration of Diagnostics (RADx) Data Hub', 'comment': 'Data from this study is available on the RADx Data Hub'}], 'references': [{'pmid': '36265090', 'type': 'BACKGROUND', 'citation': 'McDaniels-Davidson C, Arechiga-Romero M, Snyder T, Chris N, Sturgis K, Moore V, Bravo R, Famania-Martinez L, Oren E, Kiene SM. Development of an At-Home COVID-19 Test Results-Reporting System for a School District Primarily Serving Underrepresented Minority Groups, San Diego, CA, 2021-2022. Am J Public Health. 2022 Nov;112(S9):S883-S886. doi: 10.2105/AJPH.2022.307073. Epub 2022 Oct 20.'}, {'pmid': '37394511', 'type': 'RESULT', 'citation': 'Kiene SM, McDaniels-Davidson C, Lin CD, Rodriguez T, Chris N, Bravo R, Moore V, Snyder T, Arechiga-Romero M, Famania-Martinez L, Carbuccia J, Pinuelas-Morineau R, Oren E. At-Home Versus Onsite COVID-19 School-based Testing: A Randomized Noninferiority Trial. Pediatrics. 2023 Jul 1;152(Suppl 1):e2022060352F. doi: 10.1542/peds.2022-060352F.'}]}, 'descriptionModule': {'briefSummary': 'San Diego State University (SDSU), a designated Hispanic-serving institution, is partnering with Sweetwater Union High School District, an independent public school district serving 90% ethnic minority and a high proportion of socioeconomically disadvantaged students, and other community partners, to generate evidence for effective and feasible COVID-19 testing for unvaccinated and medically vulnerable middle school students and staff as part of broader COVID mitigation strategies including vaccination to return students back to school safely.', 'detailedDescription': "Equitable access to coronavirus 2019 (COVID-19) screening is important to reduce transmission and maintain in-person learning for middle school communities, particularly in disadvantaged schools. Rapid antigen testing, and at-home testing in particular, could offer substantial advantages over onsite testing from a school district's perspective, but it is unknown if engagement in at-home testing can be initiated and sustained. The investigators hypothesized that an at-home COVID-19 school testing program would be non-inferior to an onsite school COVID-19 testing program with regard to school participation rates and adherence to a weekly screening testing schedule. The study enrolled 3 middle schools within a large, predominantly Latinx-serving, independent school district into a noninferiority trial from October 2021 to March 2022. Two schools were randomized to onsite and 1 school to at-home COVID-19 testing programs. All students and staff were eligible to participate."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* student at a Sweetwater Union High School District Middle School, staff at a Sweetwater Union High School District Middle School\n\nExclusion Criteria:\n\n* \\<2 years of age\n* Not a student or staff at a participating Sweetwater Union High School District Middle School'}, 'identificationModule': {'nctId': 'NCT05150860', 'briefTitle': 'Communities Fighting COVID Return to School', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Communities Fighting COVID!: Returning Our Kids Back to School Safely', 'orgStudyIdInfo': {'id': 'HS-2021-0208'}, 'secondaryIdInfos': [{'id': '1OT2HD108112-01', 'link': 'https://reporter.nih.gov/quickSearch/1OT2HD108112-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'At-home testing', 'description': 'At-home COVID-19 testing model', 'interventionNames': ['Behavioral: At-home COVID-19 testing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'On-site testing', 'description': 'On-site COVID-19 testing model', 'interventionNames': ['Behavioral: Onsite COVID-19 testing']}], 'interventions': [{'name': 'At-home COVID-19 testing', 'type': 'BEHAVIORAL', 'description': 'At-home over-the-counter (OTC) COVID-19 testing kits provided to middle school students and staff', 'armGroupLabels': ['At-home testing']}, {'name': 'Onsite COVID-19 testing', 'type': 'BEHAVIORAL', 'description': 'Onsite COVID-19 testing for middle school students and staff', 'armGroupLabels': ['On-site testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Sweetwater Union High School District', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}]}, 'ipdSharingStatementModule': {'url': 'https://radx-hub.nih.gov/home', 'timeFrame': 'Data are available when released by NIH COVID RADx® Data Hub after study completion. Data are available as long as maintained within the Data Hub.', 'ipdSharing': 'YES', 'description': 'Data will be shared with the NIH RADx-UP Coordination and Data Collection Center (CDCC). The CDCC is charged by the NIH with making data funded by the RADx-UP initiative available to other researchers. Data are available on the NIH COVID RADx® Data Hub.', 'accessCriteria': 'Researchers can request access to the study data in the Data Hub via dbGaP, where they follow the prompts to request access. Once access is granted, the Researcher will be notified by email. If the Researcher is granted access to a specific study file, they will also have access to all the Data and Metadata files attached to the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Susan M Kiene', 'investigatorAffiliation': 'San Diego State University'}}}}