Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-26 @ 6:47 PM
Study NCT ID:
NCT04673292
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2020-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Community Collaboration to Combat COVID-19 (C-FORWARD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennings@jhmi.edu; smehta@jhu.edu; jfarley1@jhu.edu', 'phone': '410-550-4132', 'title': 'Jacky Jennings,PhD, MPH; Shruti Mehta, PhD, MPH; Jason Farley, PhD, MPH, ANP-BC, FAAN', 'organization': 'Johns Hopkins School of Medicine; Johns Hopkins Bloomberg School of Public Health; Johns Hopkins University School of Nursing'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '22 months', 'eventGroups': [{'id': 'EG000', 'title': 'Fixed Site SOC Testing', 'description': 'Fixed site Standard of Care (SOC) testing\n\nFixed site standard of care testing: This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule.', 'otherNumAtRisk': 277, 'deathsNumAtRisk': 277, 'otherNumAffected': 0, 'seriousNumAtRisk': 277, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Community-based Testing', 'description': 'Community-based, mobile van testing\n\nCommunity-based, mobile van testing: This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them.', 'otherNumAtRisk': 273, 'deathsNumAtRisk': 273, 'otherNumAffected': 0, 'seriousNumAtRisk': 273, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Self-collected Testing', 'description': "Self-collected, home-based testing\n\nSelf-collected, home-based testing: Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available.", 'otherNumAtRisk': 281, 'deathsNumAtRisk': 281, 'otherNumAffected': 0, 'seriousNumAtRisk': 281, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0.2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fixed Site SOC Testing', 'description': 'Fixed site Standard of Care (SOC) testing\n\nFixed site standard of care testing: This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule.'}, {'id': 'OG001', 'title': 'Community-based Testing', 'description': 'Community-based, mobile van testing\n\nCommunity-based, mobile van testing: This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them.'}, {'id': 'OG002', 'title': 'Self-collected Testing', 'description': "Self-collected, home-based testing\n\nSelf-collected, home-based testing: Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available."}], 'classes': [{'categories': [{'title': 'Completed PCR testing within 30 days of study randomization', 'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}, {'title': 'Did not complete PCR testing within 30 days of randomization', 'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Prevalence Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.27', 'statisticalMethod': 'Poisson Regression', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Adjusted poisson regression was performed using Study Arm as a nominal variable in the model with the Fixed Site SOC Testing as the reference group.', 'nonInferiorityComment': 'The fixed site SOC testing study arm was the standard of care and reference group. The null hypothesis was that there is not a statistically significant difference in the proportion of participants who complete PCR COVID-19 testing within 30 days of randomization when comparing community-based testing to the fixed site SOC testing.', 'otherAnalysisDescription': 'Models were adjusted for employment.'}, {'pValue': '0.43', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Prevalence Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.31', 'statisticalMethod': 'Poisson Regression', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Adjusted poisson regression was performed using Study Arm as a nominal variable in the model with the Fixed Site SOC Testing as the reference group.', 'nonInferiorityComment': 'The fixed site SOC testing study arm was the standard of care and reference group. The null hypothesis was that there is not a statistically significant difference in the proportion of participants who complete PCR COVID-19 testing within 30 days of randomization when comparing self-collected testing to the fixed site SOC testing.', 'otherAnalysisDescription': 'Models were adjusted for employment.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured within 30 days of randomization/consent', 'description': 'Uptake of SARS CoV-2 testing will be assessed by proportion of participants who are randomized and complete SARS CoV-2 testing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Completion of SARS-CoV-2 Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fixed Site SOC Testing', 'description': 'Fixed site Standard of Care (SOC) testing\n\nFixed site standard of care testing: This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule.'}, {'id': 'OG001', 'title': 'Community-based Testing', 'description': 'Community-based, mobile van testing\n\nCommunity-based, mobile van testing: This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them.'}, {'id': 'OG002', 'title': 'Self-collected Testing', 'description': "Self-collected, home-based testing\n\nSelf-collected, home-based testing: Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available."}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '11'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '10'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '12'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.05', 'pValueComment': 'aprior significance threshold: p-value\\<0.05', 'groupDescription': 'Times were censored at 30 days.', 'statisticalMethod': 'Accelerated Failure Time', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.', 'nonInferiorityComment': 'Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the community-based testing to fixed site SOC testing. Alpha threshold of 0.05.', 'otherAnalysisDescription': 'Models adjusted for employment'}, {'pValue': '0.09', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Time Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.03', 'pValueComment': 'aprior significance threshold: p-value\\<0.05', 'groupDescription': 'Times were censored at 30 days.', 'statisticalMethod': 'Accelerated Failure Time', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.', 'nonInferiorityComment': 'Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the self-collected testing arm to the fixed site SOC testing Alpha threshold of 0.05.', 'otherAnalysisDescription': 'Models adjusted for employment'}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured from randomization to testing completion (within 30 days of randomization)].', 'description': 'Time (In days) to completion of SARS CoV-2 testing from randomization', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time From SARS CoV-2 Testing to Receipt of Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fixed Site SOC Testing', 'description': 'Fixed site Standard of Care (SOC) testing\n\nFixed site standard of care testing: This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule.'}, {'id': 'OG001', 'title': 'Community-based Testing', 'description': 'Community-based, mobile van testing\n\nCommunity-based, mobile van testing: This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them.'}, {'id': 'OG002', 'title': 'Self-collected Testing', 'description': "Self-collected, home-based testing\n\nSelf-collected, home-based testing: Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available."}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.10', 'pValueComment': 'aprior threshold for significance: p\\<0.05', 'groupDescription': 'Times were censored at 10 days.', 'statisticalMethod': 'Accelerated Failure Time', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Study arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.', 'nonInferiorityComment': 'Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the community-based testing to fixed site SOC testing.', 'otherAnalysisDescription': 'Models adjusted for employment'}, {'pValue': '0.32', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Time Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.07', 'pValueComment': 'aprior significance threshold: p-value\\<0.05', 'groupDescription': 'Times were censored at 10 days.', 'statisticalMethod': 'Accelerated Failure Time', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.', 'nonInferiorityComment': 'Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the self-collected testing arm to the fixed site SOC testing.', 'otherAnalysisDescription': 'Models adjusted for employment'}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured from testing completion to receipt of results (within 10 days of testing)', 'description': 'Time (in days) from SARS CoV-2 testing completion to the receipt of results by the participant.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fixed Site SOC Testing', 'description': 'Fixed site Standard of Care (SOC) testing\n\nFixed site standard of care testing: This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule.'}, {'id': 'FG001', 'title': 'Community-based Testing', 'description': 'Community-based, mobile van testing\n\nCommunity-based, mobile van testing: This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them.'}, {'id': 'FG002', 'title': 'Self-collected Testing', 'description': "Self-collected, home-based testing\n\nSelf-collected, home-based testing: Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '277', 'numSubjects': '277'}, {'groupId': 'FG001', 'numUnits': '273', 'numSubjects': '273'}, {'groupId': 'FG002', 'numUnits': '281', 'numSubjects': '281'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '277', 'numSubjects': '277'}, {'groupId': 'FG001', 'numUnits': '273', 'numSubjects': '273'}, {'groupId': 'FG002', 'numUnits': '281', 'numSubjects': '281'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Households', 'recruitmentDetails': 'One person per household was enrolled'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}, {'value': '831', 'groupId': 'BG003'}]}, {'units': 'Households', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}, {'value': '831', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Fixed Site SOC Testing', 'description': 'Fixed site Standard of Care (SOC) testing\n\nFixed site standard of care testing: This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule.'}, {'id': 'BG001', 'title': 'Community-based Testing', 'description': 'Community-based, mobile van testing\n\nCommunity-based, mobile van testing: This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them.'}, {'id': 'BG002', 'title': 'Self-collected Testing', 'description': "Self-collected, home-based testing\n\nSelf-collected, home-based testing: Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '37', 'upperLimit': '65'}, {'value': '57', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '67'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '65'}, {'value': '56', 'groupId': 'BG003', 'lowerLimit': '39', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}, {'value': '573', 'groupId': 'BG003'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '253', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}, {'value': '756', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': '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'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '412', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Employment', 'classes': [{'categories': [{'title': 'Working now (either full or part time)', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}, {'value': '457', 'groupId': 'BG003'}]}, {'title': 'Retired/Disabled/Keeping House', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}, {'title': 'Student', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Unemployed', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Essential Worker Status', 'classes': [{'categories': [{'title': 'Essential Worker', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}]}, {'title': 'Not an Essential Worker', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '605', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Educational Attainment', 'classes': [{'categories': [{'title': 'High School Graduate or Less', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}, {'title': "Some College Level/Technical/Vocational Degree/Associate's Degree", 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}]}, {'title': "Bachelor's Degree", 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}, {'title': 'Other Advanced Degree', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '285', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Health Insurance', 'classes': [{'categories': [{'title': 'No Health Insurance', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Public (Medicare, Medicaid, Tricare)', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '315', 'groupId': 'BG003'}]}, {'title': 'Private (purchased directly or through employer)', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '342', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'History of COVID-19 Vaccination', 'classes': [{'categories': [{'title': 'Any COVID-19 Vaccination', 'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}, {'value': '719', 'groupId': 'BG003'}]}, {'title': 'No COVID-19 Vaccination', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Households'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-23', 'size': 536759, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-20T13:28', 'hasProtocol': True}, {'date': '2022-01-12', 'size': 432616, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-20T13:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each household will be randomized to one of three arms in the study: Fixed site SOC testing (Arm 1), community-based, mobile van testing (Arm 2), or self-collected, home-based testing (Arm 3).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 831}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2020-12-16', 'resultsFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-03', 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing', 'timeFrame': 'Measured within 30 days of randomization/consent', 'description': 'Uptake of SARS CoV-2 testing will be assessed by proportion of participants who are randomized and complete SARS CoV-2 testing.'}], 'secondaryOutcomes': [{'measure': 'Time to Completion of SARS-CoV-2 Testing', 'timeFrame': 'Measured from randomization to testing completion (within 30 days of randomization)].', 'description': 'Time (In days) to completion of SARS CoV-2 testing from randomization'}, {'measure': 'Time From SARS CoV-2 Testing to Receipt of Results', 'timeFrame': 'Measured from testing completion to receipt of results (within 10 days of testing)', 'description': 'Time (in days) from SARS CoV-2 testing completion to the receipt of results by the participant.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Infection']}, 'descriptionModule': {'briefSummary': 'This is randomized trial where households will be randomized to identify the optimal SARS-CoV-2 (COVID-19) testing modality in a population-representative sample of households in Baltimore City, Maryland. 1,386 households in Baltimore City will be randomized 1:1:1 to one of three testing modalities: 1) fixed-site standard of care testing; 2) community-based mobile van testing; or 3) self-collected home, based testing.', 'detailedDescription': 'The target population will include English- and Spanish-speaking families residing in Baltimore City households (N=238,427). The sample size goal is 1,386 households (0.44% of households) or 3,000 individual household members. Households will be sampled using a multi-stage approach with 1) selection of 105 of 653 census block groups (CBGs) with probabilities proportional to the estimated number of occupied households selected from 9 strata of CBGs defined by socioeconomic status and race/ethnicity with over-sampling of CBGs with harder-to-reach populations (e.g., Latinos/x, low-income whites); 2) selection of residential addresses within each of the strata via non-linear optimization; and finally, 3) screening of individuals selected for eligibility (e.g., household occupied vs. not, English/Spanish speaking).\n\nAfter completion of brief surveys, individuals will be asked to enroll other willing household members. One adult member of the household will be randomized 1:1:1 using a stratified, blocked approach with varying block sizes of 3, to one of three testing modalities: 1) fixed site standard of care testing; 2) community-based mobile van testing; or 3) self-collected home, based testing. Randomization will be stratified by geography (n=12 zones) and race/ethnicity (non-hispanic white/other, non-hispanic black and hispanic/latinx).\n\nArm 1 includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system.\n\nArm 2 includes a convenient, accessible mobile van option which will be located in the center of each of 12 geographic zones.\n\nArm 3 includes a home-based testing kit which will be delivered by courier service.\n\nOutcomes related to testing will be measured within 30 days of the initial randomization. Participants will be followed with weekly symptom pulses and monthly follow-up visits to ascertain subsequent testing need/COVID-19 symptoms. Testing during follow-up will be on-demand and participants can use either the fixed site or the home-based testing kits. The investigators will measure the impact of the time to receipt of SARS CoV-2 testing results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for households\n\n1. Selected address within Baltimore City\n2. At least one member of the household \\>18 years of age who speaks English and/or Spanish\n3. At least one member of the household provides informed consent\n4. At least one member of the household psychologically fit to complete survey\n\nInclusion Criteria for Individuals\n\n1. Reports primary residence within the sampled household\n2. Provides informed consent\n3. For children (12 years of age or older), with child assent.\n\nExclusion Criteria for households:\n\n1. Adult member of the household is under the influence of illicit substances, in the opinion of the phone interviewer\n2. Residents of nursing homes, half-ways houses or shelters\n3. Psychologically unfit to complete the survey\n4. Not a selected household address\n\nExclusion criteria for individuals\n\n1\\. Person providing informed consent is under the influence of illicit substances'}, 'identificationModule': {'nctId': 'NCT04673292', 'briefTitle': 'Community Collaboration to Combat COVID-19 (C-FORWARD)', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Community Collaboration to Combat COVID-19', 'orgStudyIdInfo': {'id': 'IRB00250298'}, 'secondaryIdInfos': [{'id': 'P30AI094189-09S1', 'link': 'https://reporter.nih.gov/quickSearch/P30AI094189-09S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fixed site SOC testing', 'description': 'Fixed site Standard of Care (SOC) testing', 'interventionNames': ['Behavioral: Fixed site standard of care testing']}, {'type': 'EXPERIMENTAL', 'label': 'Community-based testing', 'description': 'Community-based, mobile van testing', 'interventionNames': ['Behavioral: Community-based, mobile van testing']}, {'type': 'EXPERIMENTAL', 'label': 'Self-collected testing', 'description': 'Self-collected, home-based testing', 'interventionNames': ['Behavioral: Self-collected, home-based testing']}], 'interventions': [{'name': 'Fixed site standard of care testing', 'type': 'BEHAVIORAL', 'description': 'This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule.', 'armGroupLabels': ['Fixed site SOC testing']}, {'name': 'Community-based, mobile van testing', 'type': 'BEHAVIORAL', 'description': 'This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them.', 'armGroupLabels': ['Community-based testing']}, {'name': 'Self-collected, home-based testing', 'type': 'BEHAVIORAL', 'description': "Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available.", 'armGroupLabels': ['Self-collected testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': '2212 McElderry Street', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Jason E Farley, PhD, MPH, NP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University School of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}