Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT04797858
Status:
COMPLETED
Last Update Posted:
2025-05-11
First Post:
2021-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
COVID-19 Self-Testing Through Rapid Network Distribution
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': 'grossr@pennmedicine.upenn.edu', 'phone': '2158982437', 'title': 'Robert Gross', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Subjects were considered enrolled in our study for 8 weeks. 8 weeks after enrollment, they completed a follow-up survey and were then considered to have completed the study. Note that network contacts could still continue testing for COVID-19 through study completion, up to 30 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Self-Test Kit Distribution', 'description': 'Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.\n\nCOVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.', 'otherNumAtRisk': 388, 'deathsNumAtRisk': 388, 'otherNumAffected': 0, 'seriousNumAtRisk': 388, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Test Referral Distribution', 'description': 'Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.\n\nCOVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.', 'otherNumAtRisk': 388, 'deathsNumAtRisk': 388, 'otherNumAffected': 0, 'seriousNumAtRisk': 388, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Network Contact Test Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Test Kit Distribution', 'description': 'Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.\n\nCOVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.'}, {'id': 'OG001', 'title': 'Test Referral Distribution', 'description': 'Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.\n\nCOVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0077', 'ciLowerLimit': '-0.021', 'ciUpperLimit': '0.056', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'The primary outcome is the proportion of study participants who distributed tests/referrals to least two network contacts who completed testing. This outcome will be measured by number of participants with at least 2 unique network contacts who completed a test linked to a study participant by week 8. The investigators will test for differences in the primary outcome between the two study arms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Network Contact Test Uptake, End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Test Kit Distribution', 'description': 'Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.\n\nCOVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.'}, {'id': 'OG001', 'title': 'Test Referral Distribution', 'description': 'Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.\n\nCOVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.015', 'ciLowerLimit': '-0.0004', 'ciUpperLimit': '0.03', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, up to 30 months.', 'description': 'Test uptake among at least two network contacts. This outcome will be measured by the number of participants with at least two unique network contacts who completed a test linked to an index participant by end of study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Contacts Tested at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}, {'units': 'Network contacts', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1940', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Test Kit Distribution', 'description': 'Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.\n\nCOVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.'}, {'id': 'OG001', 'title': 'Test Referral Distribution', 'description': 'Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.\n\nCOVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '8 weeks', 'description': 'Number of unique network contacts who completed a test linked to an index participant by week 8. Participants analyzed reflects the number of network contacts only who completed a test.', 'unitOfMeasure': 'Network contacts', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Network contacts', 'denomUnitsSelected': 'Network contacts', 'populationDescription': 'Note that each participant could have up to 5 network contacts, so the denominator = 5 times the number of index participants.'}, {'type': 'SECONDARY', 'title': 'Number of Contacts Tested', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}, {'units': 'Network contacts', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1940', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Test Kit Distribution', 'description': 'Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.\n\nCOVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.'}, {'id': 'OG001', 'title': 'Test Referral Distribution', 'description': 'Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.\n\nCOVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through study completion, up to 30 months', 'description': 'Number of unique network contacts who completed a test linked to an index participant by end of study.', 'unitOfMeasure': 'Network contacts', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Network contacts', 'denomUnitsSelected': 'Network contacts', 'populationDescription': 'Note that each participant could have up to 5 network contacts, so the denominator = 5 times the number of index participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19 at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Test Kit Distribution', 'description': 'Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.\n\nCOVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.'}, {'id': 'OG001', 'title': 'Test Referral Distribution', 'description': 'Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.\n\nCOVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Number of participants with at least one network contact who tested positive for COVID-19 within 8 weeks of enrollment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19, End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Test Kit Distribution', 'description': 'Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.\n\nCOVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.'}, {'id': 'OG001', 'title': 'Test Referral Distribution', 'description': 'Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.\n\nCOVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, up to 30 months', 'description': 'Number of participants with at least one network contact who tested positive for COVID-19 by the end of study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Self-Test Kit Distribution', 'description': 'Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.\n\nCOVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.'}, {'id': 'FG001', 'title': 'Test Referral Distribution', 'description': 'Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.\n\nCOVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '395'}, {'groupId': 'FG001', 'numSubjects': '397'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '388'}, {'groupId': 'FG001', 'numSubjects': '388'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Excluded due to administrative error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '776', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Self-Test Kit Distribution', 'description': 'Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.\n\nCOVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.'}, {'id': 'BG001', 'title': 'Test Referral Distribution', 'description': 'Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.\n\nCOVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '776', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '352', 'groupId': 'BG000'}, {'value': '352', 'groupId': 'BG001'}, {'value': '704', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '776', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '58'}, {'value': '44', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '56'}, {'value': '44', 'groupId': 'BG002', 'lowerLimit': '32', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'BG000'}, {'value': '387', 'groupId': 'BG001'}, {'value': '774', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '2 individuals declined to answer.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '776', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '322', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '640', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Not all participants provided data or agreed to answer this question.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '776', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '479', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '776', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '388', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '776', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-28', 'size': 698680, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-01T10:11', 'hasProtocol': True}, {'date': '2023-05-19', 'size': 630539, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-20T09:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 792}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2021-03-05', 'resultsFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2021-03-12', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-08', 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Network Contact Test Uptake', 'timeFrame': '8 weeks', 'description': 'The primary outcome is the proportion of study participants who distributed tests/referrals to least two network contacts who completed testing. This outcome will be measured by number of participants with at least 2 unique network contacts who completed a test linked to a study participant by week 8. The investigators will test for differences in the primary outcome between the two study arms.'}], 'secondaryOutcomes': [{'measure': 'Network Contact Test Uptake, End of Study', 'timeFrame': 'Through study completion, up to 30 months.', 'description': 'Test uptake among at least two network contacts. This outcome will be measured by the number of participants with at least two unique network contacts who completed a test linked to an index participant by end of study.'}, {'measure': 'Number of Contacts Tested at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Number of unique network contacts who completed a test linked to an index participant by week 8. Participants analyzed reflects the number of network contacts only who completed a test.'}, {'measure': 'Number of Contacts Tested', 'timeFrame': 'Through study completion, up to 30 months', 'description': 'Number of unique network contacts who completed a test linked to an index participant by end of study.'}, {'measure': 'Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19 at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Number of participants with at least one network contact who tested positive for COVID-19 within 8 weeks of enrollment.'}, {'measure': 'Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19, End of Study', 'timeFrame': 'Through study completion, up to 30 months', 'description': 'Number of participants with at least one network contact who tested positive for COVID-19 by the end of study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '33471114', 'type': 'BACKGROUND', 'citation': 'Bien-Gund C, Dugosh K, Acri T, Brady K, Thirumurthy H, Fishman J, Gross R. Factors Associated With US Public Motivation to Use and Distribute COVID-19 Self-tests. JAMA Netw Open. 2021 Jan 4;4(1):e2034001. doi: 10.1001/jamanetworkopen.2020.34001.'}, {'pmid': '29771792', 'type': 'BACKGROUND', 'citation': "Lightfoot MA, Campbell CK, Moss N, Treves-Kagan S, Agnew E, Kang Dufour MS, Scott H, Sa'id AM, Lippman SA. Using a Social Network Strategy to Distribute HIV Self-Test Kits to African American and Latino MSM. J Acquir Immune Defic Syndr. 2018 Sep 1;79(1):38-45. doi: 10.1097/QAI.0000000000001726."}, {'pmid': '25590331', 'type': 'BACKGROUND', 'citation': 'Golden MR, Kerani RP, Stenger M, Hughes JP, Aubin M, Malinski C, Holmes KK. Uptake and population-level impact of expedited partner therapy (EPT) on Chlamydia trachomatis and Neisseria gonorrhoeae: the Washington State community-level randomized trial of EPT. PLoS Med. 2015 Jan 15;12(1):e1001777. doi: 10.1371/journal.pmed.1001777. eCollection 2015 Jan.'}, {'pmid': '32592670', 'type': 'BACKGROUND', 'citation': 'Bagcchi S. Stigma during the COVID-19 pandemic. Lancet Infect Dis. 2020 Jul;20(7):782. doi: 10.1016/S1473-3099(20)30498-9. No abstract available.'}, {'pmid': '31738378', 'type': 'BACKGROUND', 'citation': 'MacGowan RJ, Chavez PR, Borkowf CB, Owen SM, Purcell DW, Mermin JH, Sullivan PS; eSTAMP Study Group. Effect of Internet-Distributed HIV Self-tests on HIV Diagnosis and Behavioral Outcomes in Men Who Have Sex With Men: A Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):117-125. doi: 10.1001/jamainternmed.2019.5222.'}, {'pmid': '32530469', 'type': 'BACKGROUND', 'citation': 'Altamirano J, Govindarajan P, Blomkalns AL, Kushner LE, Stevens BA, Pinsky BA, Maldonado Y. Assessment of Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for Severe Acute Respiratory Syndrome Coronavirus 2Testing. JAMA Netw Open. 2020 Jun 1;3(6):e2012005. doi: 10.1001/jamanetworkopen.2020.12005.'}, {'pmid': '27240789', 'type': 'BACKGROUND', 'citation': 'Thirumurthy H, Masters SH, Mavedzenge SN, Maman S, Omanga E, Agot K. Promoting male partner HIV testing and safer sexual decision making through secondary distribution of self-tests by HIV-negative female sex workers and women receiving antenatal and post-partum care in Kenya: a cohort study. Lancet HIV. 2016 Jun;3(6):e266-74. doi: 10.1016/S2352-3018(16)00041-2. Epub 2016 Apr 8.'}, {'pmid': '40465296', 'type': 'DERIVED', 'citation': 'Bien-Gund CH, Stephens-Shields AJ, Acri T, Dugosh K, Gross R. Provision of COVID-19 Self-Test Kits to Patients for Distribution to Social Contacts: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2513708. doi: 10.1001/jamanetworkopen.2025.13708.'}]}, 'descriptionModule': {'briefSummary': 'COVID-19, the coronavirus disease caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), has led to a global pandemic and has exacerbated existing health inequities among vulnerable populations. Despite higher rates of COVID-19 in Black and Latinx individuals compared to White individuals, rates of testing in predominately non-White, low-income communities are significantly lower than in high-income areas. Self-testing, where individuals collect their own samples, is now feasible for the detection of SARS-CoV-2. One promising approach to increase test uptake is the secondary distribution of self-testing kits, where an individual distributes tests to contacts in their social network and encourages them to self-test.\n\nThe central hypothesis of this clinical trial is that the secondary distribution of SARS-CoV-2 self-tests can significantly expand test uptake among underserved populations. To test this hypothesis, the investigators will conduct a 1:1 randomized controlled trial that will assess a self-testing intervention that promotes the secondary distribution of SARS-CoV-2 test kits compared with test referrals, with a focus on reaching underserved populations.', 'detailedDescription': 'Strategies to rapidly disseminate COVID-19 testing are urgently needed, particularly to address increasing health disparities among underserved communities. One promising approach to increase test uptake is the secondary distribution of self-tests, where an individual distributes test kits to contacts in their social network and encourages them to self-test. By decentralizing testing, this approach does not require individuals to have contact with medical systems, and can lower potential barriers to obtaining testing. This approach can increase case detection by facilitating testing among exposed individuals, and potentially ameliorate stigma, fear, and medical mistrust associated with COVID-19 among vulnerable populations because the testing process is decentralized.\n\nThe investigators will conduct a 1:1 randomized controlled trial randomizing individuals to receive either multiple self-test kits to distribute within their social circles, or referrals for standard clinic-based tests. All study participants will be offered testing upon enrollment. Study participants, deemed "Index Participants," will be randomized to receive multiple self-testing kits (intervention) or test referral cards and text messages (control) to encourage individuals in their social networks, deemed "network contacts" to test. Participants will complete a baseline evaluation and a follow-up evaluation at 8 weeks. We will measure network contact test uptake in both study arms. The central hypothesis of this trial is that distribution of self-test kits will increase test uptake compared with distribution of test referrals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Has a working telephone number\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Does not have a working telephone number\n* Prior COVID-19 infection in the past 90 days\n* Previously received a COVID-19 test as part of this COVID-19 research study\n* Unable or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04797858', 'acronym': 'C-STRAND', 'briefTitle': 'COVID-19 Self-Testing Through Rapid Network Distribution', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Secondary Distribution of COVID-19 Self-tests vs. Referrals to Increase Test Uptake in Underserved Populations', 'orgStudyIdInfo': {'id': '3R01HL151292-01S1', 'link': 'https://reporter.nih.gov/quickSearch/3R01HL151292-01S1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-Test kit distribution', 'description': 'Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.', 'interventionNames': ['Behavioral: COVID-19 self-test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test referral distribution', 'description': 'Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.', 'interventionNames': ['Behavioral: COVID-19 test referral']}], 'interventions': [{'name': 'COVID-19 self-test', 'type': 'BEHAVIORAL', 'description': '5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.', 'armGroupLabels': ['Self-Test kit distribution']}, {'name': 'COVID-19 test referral', 'type': 'BEHAVIORAL', 'description': '5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.', 'armGroupLabels': ['Test referral distribution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Public Health Management Corporation', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Robert Gross, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health Management Corporation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Robert Gross', 'investigatorAffiliation': 'University of Pennsylvania'}}}}