Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04875520
Status:
COMPLETED
Last Update Posted:
2025-07-04
First Post:
2021-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population
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': 'Jason.Newland@nationwidechildrens.org', 'phone': '614-722-3416', 'title': 'Jason G. Newland, MD', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "Small sample size. Local and federal COVID-19 recommendations and precautions were continuously changing. The omicron surge in St. Louis presented an unforeseeable strain on the study's testing resources, and symptomatic testing had to be paused for 37 days. Due to the specific PCR test utilized not being designed for a high positivity rate. Study experienced lower recruitment than expected."}}, 'adverseEventsModule': {'description': 'Deaths, serious adverse events, and non-serious adverse events were not assessed for study participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Weekly Screening Testing Plus Symptomatic Testing', 'description': 'Among 16 middle and high schools, 8 will be randomized to offer students and staff weekly SARS-CoV-2 testing. Additionally, these schools will offer testing for symptomatic students, staff, household members in all age groups.\n\nScreening testing strategy: The intervention we are evaluating is the use of weekly screening testing among students and staff.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Symptomatic Testing', 'description': 'All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons.\n\nNo screening testing strategy: a group of schools will not receive screening testing.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Rate of All COVID-19 Cases in Schools.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}, {'units': 'Completed tests', 'counts': [{'value': '6436', 'groupId': 'OG000'}, {'value': '7488', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Weekly Screening Testing Plus Symptomatic Testing', 'description': 'Total reported school cases during study period divided by school population.'}, {'id': 'OG001', 'title': 'Symptomatic Testing', 'description': 'Total reported school cases during study period divided by school population.'}], 'classes': [{'categories': [{'measurements': [{'value': '453', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01845', 'ciLowerLimit': '-0.04981', 'ciUpperLimit': '0.01292', 'statisticalMethod': 'generalized estimating equations', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Overall rate compared using GEE model includes any person affiliated with the school who tested positive at least once during the study period that the schools reported to us that were positive. This includes people in our testing program and not in our testing program.'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to one year.', 'description': 'The rate of all new COVID-19 cases of student/staff in schools per randomization group.', 'unitOfMeasure': 'Completed tests', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Completed tests', 'denomUnitsSelected': 'Completed tests', 'populationDescription': 'The unit analyzed were the number of the tests completed overall during the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Weekly Screening Testing Plus Symptomatic Testing', 'description': 'Among 16 middle and high schools, 8 will be randomized to offer students and staff weekly SARS-CoV-2 testing. Additionally, these schools will offer testing for symptomatic students, staff, household members in all age groups.\n\nScreening testing strategy: The intervention we are evaluating is the use of weekly screening testing among students and staff.'}, {'id': 'FG001', 'title': 'Symptomatic Testing', 'description': 'All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons.\n\nNo screening testing strategy: a group of schools will not receive screening testing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '894'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '496'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '797'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '460'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '97'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '36'}]}]}], 'typeUnitsAnalyzed': 'schools', 'recruitmentDetails': 'All students, staff, and family members from 16 middle and high schools were eligible to participate.', 'preAssignmentDetails': '1390 individuals from 16 middle and high schools were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'BG000'}, {'value': '496', 'groupId': 'BG001'}, {'value': '1390', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Weekly Screening Testing Plus Symptomatic Testing', 'description': 'Among 16 middle and high schools, 8 will be randomized to offer students and staff weekly SARS-CoV-2 testing. Additionally, these schools will offer testing for symptomatic students, staff, household members in all age groups.\n\nScreening testing strategy: The intervention we are evaluating is the use of weekly screening testing among students and staff.'}, {'id': 'BG001', 'title': 'Symptomatic Testing', 'description': 'All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons.\n\nNo screening testing strategy: a group of schools will not receive screening testing.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'BG000'}, {'value': '496', 'groupId': 'BG001'}, {'value': '1390', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '47'}, {'value': '30', 'groupId': 'BG001', 'lowerLimit': '13', 'upperLimit': '48'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '15', 'upperLimit': '47'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'BG000'}, {'value': '496', 'groupId': 'BG001'}, {'value': '1390', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '530', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '829', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '310', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '485', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'BG000'}, {'value': '496', 'groupId': 'BG001'}, {'value': '1390', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '771', 'groupId': 'BG000'}, {'value': '413', 'groupId': 'BG001'}, {'value': '1184', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'BG000'}, {'value': '496', 'groupId': 'BG001'}, {'value': '1390', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '605', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '431', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '575', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Participant Type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'BG000'}, {'value': '469', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Staff', 'measurements': [{'value': '353', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '556', 'groupId': 'BG002'}]}, {'title': 'Student', 'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}, {'title': 'Household', 'measurements': [{'value': '290', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data'}, {'title': 'Received COVID-19 Vaccine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'BG000'}, {'value': '496', 'groupId': 'BG001'}, {'value': '1390', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '509', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '761', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '317', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Other = prefer not to answer and unknown.', 'unitOfMeasure': 'Participants'}, {'title': 'Social Vulnerability Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '875', 'groupId': 'BG000'}, {'value': '491', 'groupId': 'BG001'}, {'value': '1366', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Low', 'measurements': [{'value': '293', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}, {'title': 'Low-Medium', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}, {'title': 'Medium - High', 'measurements': [{'value': '331', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}, {'title': 'High', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-24', 'size': 248563, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-23T15:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2021-04-29', 'resultsFirstSubmitDate': '2024-12-26', 'studyFirstSubmitQcDate': '2021-05-05', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-17', 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Rate of All COVID-19 Cases in Schools.', 'timeFrame': 'Up to one year.', 'description': 'The rate of all new COVID-19 cases of student/staff in schools per randomization group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Screening testing', 'School-based COVID-19 Transmission'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '33735165', 'type': 'BACKGROUND', 'citation': 'Van Dyke ME, Mendoza MCB, Li W, Parker EM, Belay B, Davis EM, Quint JJ, Penman-Aguilar A, Clarke KEN. Racial and Ethnic Disparities in COVID-19 Incidence by Age, Sex, and Period Among Persons Aged <25 Years - 16 U.S. Jurisdictions, January 1-December 31, 2020. MMWR Morb Mortal Wkly Rep. 2021 Mar 19;70(11):382-388. doi: 10.15585/mmwr.mm7011e1.'}, {'pmid': '32551773', 'type': 'BACKGROUND', 'citation': 'Bryant DJ, Oo M, Damian AJ. The rise of adverse childhood experiences during the COVID-19 pandemic. Psychol Trauma. 2020 Aug;12(S1):S193-S194. doi: 10.1037/tra0000711. Epub 2020 Jun 18.'}, {'pmid': '33230400', 'type': 'BACKGROUND', 'citation': 'Benner AD, Mistry RS. Child Development During the COVID-19 Pandemic Through a Life Course Theory Lens. Child Dev Perspect. 2020 Dec;14(4):236-243. doi: 10.1111/cdep.12387. Epub 2020 Oct 15.'}, {'pmid': '33419869', 'type': 'BACKGROUND', 'citation': 'Zimmerman KO, Akinboyo IC, Brookhart MA, Boutzoukas AE, McGann KA, Smith MJ, Maradiaga Panayotti G, Armstrong SC, Bristow H, Parker D, Zadrozny S, Weber DJ, Benjamin DK Jr; ABC SCIENCE COLLABORATIVE. Incidence and Secondary Transmission of SARS-CoV-2 Infections in Schools. Pediatrics. 2021 Apr;147(4):e2020048090. doi: 10.1542/peds.2020-048090. Epub 2021 Jan 8.'}, {'pmid': '33507890', 'type': 'BACKGROUND', 'citation': 'Falk A, Benda A, Falk P, Steffen S, Wallace Z, Hoeg TB. COVID-19 Cases and Transmission in 17 K-12 Schools - Wood County, Wisconsin, August 31-November 29, 2020. MMWR Morb Mortal Wkly Rep. 2021 Jan 29;70(4):136-140. doi: 10.15585/mmwr.mm7004e3.'}, {'pmid': '32980377', 'type': 'BACKGROUND', 'citation': 'Orscheln RC, Newland JG, Rosen DA. Practical School Algorithms for Symptomatic or SARS-CoV-2-Exposed Students Are Essential for Returning Children to In-Person Learning. J Pediatr. 2021 Feb;229:275-277. doi: 10.1016/j.jpeds.2020.09.060. Epub 2020 Sep 25. No abstract available.'}, {'pmid': '32213337', 'type': 'BACKGROUND', 'citation': 'To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.'}, {'pmid': '32511508', 'type': 'BACKGROUND', 'citation': 'Lalli MA, Langmade SJ, Chen X, Fronick CC, Sawyer CS, Burcea LC, Wilkinson MN, Fulton RS, Heinz M, Buchser WJ, Head RD, Mitra RD, Milbrandt J. Rapid and extraction-free detection of SARS-CoV-2 from saliva with colorimetric LAMP. medRxiv [Preprint]. 2020 Aug 6:2020.05.07.20093542. doi: 10.1101/2020.05.07.20093542.'}, {'pmid': '16204405', 'type': 'BACKGROUND', 'citation': 'Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.'}, {'pmid': '35698094', 'type': 'DERIVED', 'citation': 'Hayes S, Malone S, Bonty B, Mueller N, Reyes SM, Reyes SA, Evans C, Wilcher-Roberts M, Watterson T, Akuse S, Shelley J, Yuan G, Lackey I, Prater J, Montgomery B, Williams C, Butler-Barnes ST, Harris K, Caburnay C, Dougherty NL, Liu J, Lai A, Neidich J, Fritz S, Newland JG. Assessing COVID-19 testing strategies in K-12 schools in underserved populations: study protocol for a cluster-randomized trial. BMC Public Health. 2022 Jun 13;22(1):1177. doi: 10.1186/s12889-022-13577-z.'}], 'seeAlsoLinks': [{'url': 'http://www.propublica.org/article/early-data-shows-african-americans-have-contracted-and-died-of-coronavirus-at-an-alarming-rate', 'label': 'Johnson A, Buford T. Early Data Shows African Americans Have Contracted and Died of Coronavirus at an Alarming Rate. Propublica. 2020. Accessed March 11, 2021'}, {'url': 'https://www.educationnext.org/pandemic-parent-survey-finds-perverse-pattern-students-more-likely-to-be-attending-school-in-person-where-covid-is-spreading-more-rapidly', 'label': 'Henderson MB, West MR, Peterson PE. Pandemic Parent Survey Finds Perverse Pattern: Students are More Likely to Be Attending School in Person Where COVID Is Spreading More Rapidly. Education Next. 2021;21(2). Accessed March 11, 2021'}]}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to determine the most effective SARS-CoV-2 testing strategy for successful return of in-person school in the under-served communities of St. Louis.\n\nRegular screening testing has been recommended by the CDC as an additive mitigation strategy for in-person schools in areas of high community transmission. We will compare the effectiveness and acceptance of two different school-based testing strategies among students and school staff (symptomatic testing only versus weekly surveillance testing plus symptomatic testing), measuring school-based SARS-CoV-2 transmission through a cluster randomized trial.', 'detailedDescription': 'We will complete a cluster randomized trial to compare the incidence of school-based SARS-CoV-2 transmission between weekly screening testing of students and school staff versus testing only symptomatic students and staff. In this proposal, 16 middle and high schools from five school districts in the St. Louis metropolitan area will be cluster randomized to screening testing plus symptomatic testing versus symptomatic testing alone. The symptomatic testing will be provided to the entire school community as well as household members of students and staff.\n\nThe second Aim will evaluate existing mitigation strategies utilized in schools and the rate of school-based SARS-CoV-2 transmission by defining the mitigation strategies utilized in participating schools through survey tools developed with CDC and their impact on school-based COVID-19 transmission and quantifying the rate of COVID-19 transmission in schools and the impact of this transmission on households through extensive interviews and testing of contacts and household members.\n\nOur 3rd Aim involves partnering with community-based organizations to specify and address the social, ethical, and behavioral implications of in-person schooling during the COVID-19 pandemic and the impact of SARS-CoV-2 testing on the school and community. Listening sessions will be utilized to understand barriers and facilitators to testing, ethical concerns of the community in research participation, and the behavioral health impact of lack of in-person schooling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A student or staff in one of the five school districts.\n* Household members of a student or staff member in the five school districts.\n\nExclusion Criteria:\n\n* People not affiliated with the school.'}, 'identificationModule': {'nctId': 'NCT04875520', 'briefTitle': 'Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population', 'orgStudyIdInfo': {'id': '202104013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Weekly Screening testing plus symptomatic testing', 'description': 'Among 16 middle and high schools, 8 will be randomized to offer students and staff weekly SARS-CoV-2 testing. Additionally, these schools will offer testing for symptomatic students, staff, household members in all age groups.', 'interventionNames': ['Other: Screening testing strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Symptomatic testing', 'description': 'All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons.', 'interventionNames': ['Other: No screening testing strategy']}], 'interventions': [{'name': 'Screening testing strategy', 'type': 'OTHER', 'description': 'The intervention we are evaluating is the use of weekly screening testing among students and staff.', 'armGroupLabels': ['Weekly Screening testing plus symptomatic testing']}, {'name': 'No screening testing strategy', 'type': 'OTHER', 'description': 'a group of schools will not receive screening testing.', 'armGroupLabels': ['Symptomatic testing']}]}, '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': '63121', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Normandy Schools Collaborative', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63130', 'city': 'University City', 'state': 'Missouri', 'country': 'United States', 'facility': 'The School District of University City', 'geoPoint': {'lat': 38.65588, 'lon': -90.30928}}], 'overallOfficials': [{'name': 'Jason G. Newland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}