Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT04766333
Status:
COMPLETED
Last Update Posted:
2023-03-10
First Post:
2021-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
New Jersey Healthcare Essential Worker Outreach and Education Study - Testing Overlooked Occupations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D015438', 'term': 'Health Behavior'}], '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'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hudsonsh@rutgers.edu', 'phone': '848-932-0215', 'title': 'Shawna V. Hudson', 'organization': 'Rutgers University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Healthcare Worker Focused Outreach Intervention Strategy', 'description': 'Healthcare Worker Focused Outreach Intervention Strategy\n\nHealthcare Worker Focused Outreach: This a focused outreach intervention strategy specifically designed for healthcare workers.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Community Organization Led Outreach', 'description': 'Community Organization Led Outreach\n\nCommunity Organization Led Outreach: This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach.', 'otherNumAtRisk': 211, 'deathsNumAtRisk': 211, 'otherNumAffected': 0, 'seriousNumAtRisk': 211, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Complete COVID-19 Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '1037', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthcare Worker Focused Outreach Intervention Strategy', 'description': 'Healthcare Worker Focused Outreach Intervention Strategy\n\nHealthcare Worker Focused Outreach: This a focused outreach intervention strategy specifically designed for healthcare workers.'}, {'id': 'OG001', 'title': 'Community Organization Led Outreach', 'description': 'Community Organization Led Outreach\n\nCommunity Organization Led Outreach: This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.17', 'ciUpperLimit': '1.23', 'estimateComment': 'Healthcare Arm is the reference category', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of participants who return their saliva testing kit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthcare Worker Focused Outreach Intervention Strategy', 'description': 'Healthcare Worker Focused Outreach Intervention Strategy\n\nHealthcare Worker Focused Outreach: This a focused outreach intervention strategy specifically designed for healthcare workers.'}, {'id': 'FG001', 'title': 'Community Organization Led Outreach', 'description': 'Community Organization Led Outreach\n\nCommunity Organization Led Outreach: This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '1037'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '211'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '826'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '826'}]}]}], 'recruitmentDetails': 'From May through December 2021, 2017 eligible New Jersey residents registered for and consented to be part of an on-line study with a single questionnaire (including items on sociodemographic characteristics as well as COVID-19-related perceptions, behaviors, and challenges), after which they were able to order a free at-home saliva COVID-19 polymerase chain reaction test.', 'preAssignmentDetails': 'Some participants (n=917) chose not to participate in the questionnaire data collection and as a result were not assigned to a study arm after consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthcare Worker Focused Outreach Intervention Strategy', 'description': 'Healthcare Worker Focused Outreach Intervention Strategy\n\nHealthcare Worker Focused Outreach: This a focused outreach intervention strategy specifically designed for healthcare workers.'}, {'id': 'BG001', 'title': 'Community Organization Led Outreach', 'description': 'Community Organization Led Outreach\n\nCommunity Organization Led Outreach: This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '51'}, {'value': '44', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '63'}, {'value': '40.5', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black, non-Latino', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}, {'title': 'Latino, non-Black', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'Black and Latino', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-21', 'size': 1545843, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-10T12:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2017}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2021-02-10', 'resultsFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-08', 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Complete COVID-19 Testing', 'timeFrame': '1 year', 'description': 'Number of participants who return their saliva testing kit.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Health Care Seeking Behavior', 'Health Behavior']}, 'referencesModule': {'references': [{'pmid': '34264327', 'type': 'BACKGROUND', 'citation': 'Jimenez ME, Rivera-Nunez Z, Crabtree BF, Hill D, Pellerano MB, Devance D, Macenat M, Lima D, Martinez Alcaraz E, Ferrante JM, Barrett ES, Blaser MJ, Panettieri RA Jr, Hudson SV. Black and Latinx Community Perspectives on COVID-19 Mitigation Behaviors, Testing, and Vaccines. JAMA Netw Open. 2021 Jul 1;4(7):e2117074. doi: 10.1001/jamanetworkopen.2021.17074.'}, {'pmid': '36265092', 'type': 'BACKGROUND', 'citation': 'Barrett ES, Andrews TR, Roy J, Greenberg P, Ferrante JM, Horton DB, Gordon M, Rivera-Nunez Z, Pellerano MB, Tallia AF, Budolfson M, Georgopoulos P, Reed D, Lynn B, Rosati R, Castaneda M, Dixon F, Pernell C, Hill D, Jimenez ME, Blaser MJ, Panettieri R Jr, Hudson SV. Community- Versus Health Care Organization-Based Approaches to Expanding At-Home COVID-19 Testing in Black and Latino Communities, New Jersey, 2021. Am J Public Health. 2022 Nov;112(S9):S918-S922. doi: 10.2105/AJPH.2022.306989. Epub 2022 Oct 20.'}, {'pmid': '35041702', 'type': 'BACKGROUND', 'citation': 'Rivera-Nunez Z, Jimenez ME, Crabtree BF, Hill D, Pellerano MB, Devance D, Macenat M, Lima D, Gordon M, Sullivan B, Rosati RJ, Ferrante JM, Barrett ES, Blaser MJ, Panettieri RA Jr, Hudson SV. Experiences of Black and Latinx health care workers in support roles during the COVID-19 pandemic: A qualitative study. PLoS One. 2022 Jan 18;17(1):e0262606. doi: 10.1371/journal.pone.0262606. eCollection 2022.'}, {'pmid': '36108254', 'type': 'DERIVED', 'citation': 'Juarez R, Phankitnirundorn K, Ramirez A, Peres R, Maunakea AK, Okihiro M. Vaccine-Associated Shifts in SARS-CoV-2 Infectivity Among the Native Hawaiian and Other Pacific Islander Population in Hawaii. Am J Public Health. 2022 Nov;112(S9):S896-S899. doi: 10.2105/AJPH.2022.306973. Epub 2022 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'This mixed methods study evaluates the effectiveness and cost of a healthcare worker focused outreach intervention strategy versus community organization led outreach to explore contextual factors (individual, family, and community) affecting COVID-19 testing implementation outcomes and scalability.', 'detailedDescription': 'In Aim 2, the investigators conduct a mixed methods study to evaluate the effectiveness and cost of: (1) the healthcare worker focused outreach intervention strategy versus (2) community organization led outreach working with community based organizations. The investigators explore contextual factors (individual, family, and community) affecting COVID-19 testing implementation outcomes and scalability. The primary outcome is uptake of COVID-19 testing using the novel Rutgers Clinical Genomics Laboratory/RUCDR saliva test, the first FDA authorized diagnostic test using saliva to detect SARS-CoV-2 for non-invasive, home based self-testing. To compare participation rates in the two arms, our primary outcome, the investigators will use data on the number of tests performed per month up to a 12 month study period. For each intervention, the start time is the date of first attempted contact with potential participants and the end date is either the end of the study period, or the date at which the 1000th individual was tested (whichever comes first).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Community Members and Healthcare Workers\n\n* Self-identification as Black or Hispanic/Latino.\n* Resident of Union, Passaic, Middlesex, or Essex County, NJ.\n* Parent/legal guardian able to provide permission to participate for those under 18\n\nExclusion Criteria:\n\n* Under 4 years of age.\n* Unable to speak, understand, and/or read English or Spanish.\n* Unable to provide informed consent/assent'}, 'identificationModule': {'nctId': 'NCT04766333', 'briefTitle': 'New Jersey Healthcare Essential Worker Outreach and Education Study - Testing Overlooked Occupations', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'NJ HEROES TOO (New Jersey Healthcare Essential Worker Outreach and Education Study - Testing Overlooked Occupations)', 'orgStudyIdInfo': {'id': '2020002549'}, 'secondaryIdInfos': [{'id': '3UL1TR003017-02S2', 'link': 'https://reporter.nih.gov/quickSearch/3UL1TR003017-02S2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthcare Worker Focused Outreach Intervention Strategy', 'description': 'Healthcare Worker Focused Outreach Intervention Strategy', 'interventionNames': ['Behavioral: Healthcare Worker Focused Outreach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Community Organization Led Outreach', 'description': 'Community Organization Led Outreach', 'interventionNames': ['Behavioral: Community Organization Led Outreach']}], 'interventions': [{'name': 'Healthcare Worker Focused Outreach', 'type': 'BEHAVIORAL', 'otherNames': ['Informational intervention'], 'description': 'This a focused outreach intervention strategy specifically designed for healthcare workers.', 'armGroupLabels': ['Healthcare Worker Focused Outreach Intervention Strategy']}, {'name': 'Community Organization Led Outreach', 'type': 'BEHAVIORAL', 'otherNames': ['Informational intervention'], 'description': 'This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach.', 'armGroupLabels': ['Community Organization Led Outreach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers University', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Research Division Chief Department of Family Medicine and Community Health', 'investigatorFullName': 'Shawna V. Hudson, PhD', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}