Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-11 @ 5:24 PM
Study NCT ID:
NCT05533918
Status:
COMPLETED
Last Update Posted:
2025-01-16
First Post:
2022-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Text Message Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062526', 'term': 'Patient Navigation'}], 'ancestors': [{'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'guilherme.delfiol@utah.edu', 'phone': '801-581-4080', 'title': 'Dr. Guilherme Del Fiol', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '10 months', 'description': 'This study was a text message based study that had little risk to participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.', 'otherNumAtRisk': 7861, 'deathsNumAtRisk': 7861, 'otherNumAffected': 0, 'seriousNumAtRisk': 7861, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.', 'otherNumAtRisk': 7860, 'deathsNumAtRisk': 7860, 'otherNumAffected': 0, 'seriousNumAtRisk': 7860, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.', 'otherNumAtRisk': 7856, 'deathsNumAtRisk': 7856, 'otherNumAffected': 0, 'seriousNumAtRisk': 7856, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.\n\nIntervention message frequency is every 30 days for a total of 3 messages.', 'otherNumAtRisk': 7862, 'deathsNumAtRisk': 7862, 'otherNumAffected': 0, 'seriousNumAtRisk': 7862, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reach-Accept Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7861', 'groupId': 'OG000'}, {'value': '7860', 'groupId': 'OG001'}, {'value': '7856', 'groupId': 'OG002'}, {'value': '7862', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'OG001', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.'}, {'id': 'OG002', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'OG003', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.\n\nIntervention message frequency is every 30 days for a total of 3 messages.'}], 'classes': [{'categories': [{'measurements': [{'value': '509', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}, {'value': '329', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]', 'description': 'Number of patients that accept an offer to receive an at-home test kit and verify mailing address', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reach-Engage Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7861', 'groupId': 'OG000'}, {'value': '7860', 'groupId': 'OG001'}, {'value': '7856', 'groupId': 'OG002'}, {'value': '7862', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'OG001', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.'}, {'id': 'OG002', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'OG003', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.\n\nIntervention message frequency is every 30 days for a total of 3 messages.'}], 'classes': [{'categories': [{'measurements': [{'value': '785', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}, {'value': '603', 'groupId': 'OG002'}, {'value': '554', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]', 'description': 'Number of patients that reply to an offer to receive an at-home rapid test kit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PN-Request', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7856', 'groupId': 'OG002'}, {'value': '7862', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'OG001', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.'}, {'id': 'OG002', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'OG003', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.\n\nIntervention message frequency is every 30 days for a total of 3 messages.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]', 'description': 'Number of PN participants that request a Patient Navigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Groups analyzed for this outcome are only PN groups/arms. No Patient Navigation (NoPN) groups were not analyzed for this outcome since patient navigation was not offered to those groups.'}, {'type': 'SECONDARY', 'title': 'PN-Engage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7856', 'groupId': 'OG002'}, {'value': '7862', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'OG001', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.'}, {'id': 'OG002', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'OG003', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.\n\nIntervention message frequency is every 30 days for a total of 3 messages.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]', 'description': 'Number of PN participants that speak to a Patient Navigator', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Groups analyzed for this outcome are only PN groups/arms. No Patient Navigation (NoPN) groups were not analyzed for this outcome since patient navigation was not offered to those groups.'}, {'type': 'SECONDARY', 'title': 'Opt-out', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7861', 'groupId': 'OG000'}, {'value': '7860', 'groupId': 'OG001'}, {'value': '7856', 'groupId': 'OG002'}, {'value': '7862', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'OG001', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.'}, {'id': 'OG002', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'OG003', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.\n\nIntervention message frequency is every 30 days for a total of 3 messages.'}], 'classes': [{'categories': [{'measurements': [{'value': '982', 'groupId': 'OG000'}, {'value': '583', 'groupId': 'OG001'}, {'value': '995', 'groupId': 'OG002'}, {'value': '564', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Daily [up to 90 days post intervention messaging)', 'description': 'Number of participants that opt out throughout the duration of the intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self Reported Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}, {'value': '200', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'OG001', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.'}, {'id': 'OG002', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'OG003', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.\n\nIntervention message frequency is every 30 days for a total of 3 messages.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days post intervention messaging', 'description': 'Participants who self-reported testing as completed. Reported only for participants who requested COVID-19 test kits from the study and responded to follow-up messages.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were only analyzed if they requested a COVID-19 test kit and responded to follow up messages. Not all participants completed both requirements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'FG001', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.'}, {'id': 'FG002', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'FG003', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.\n\nIntervention message frequency is every 30 days for a total of 3 messages.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7861'}, {'groupId': 'FG001', 'numSubjects': '7860'}, {'groupId': 'FG002', 'numSubjects': '7856'}, {'groupId': 'FG003', 'numSubjects': '7862'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6879'}, {'groupId': 'FG001', 'numSubjects': '7277'}, {'groupId': 'FG002', 'numSubjects': '6861'}, {'groupId': 'FG003', 'numSubjects': '7298'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '982'}, {'groupId': 'FG001', 'numSubjects': '583'}, {'groupId': 'FG002', 'numSubjects': '995'}, {'groupId': 'FG003', 'numSubjects': '564'}]}]}], 'recruitmentDetails': 'This study recruited participants in partnership with the Association for Utah Community Health and its affiliated Community Health Centers (CHCs). Three CHCs with 12 primary care clinics participated. Eligible patients had an appointment at one of the participating CHCs in the last 3 years, were 18 years and older, and had a valid cellphone number in the CHC EHR.', 'preAssignmentDetails': '1. Opted out- opted out at introductory message but before randomization\n2. Reported not having a smart phone\n3. Did not respond to introductory message'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7861', 'groupId': 'BG000'}, {'value': '7860', 'groupId': 'BG001'}, {'value': '7856', 'groupId': 'BG002'}, {'value': '7862', 'groupId': 'BG003'}, {'value': '31439', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'BG001', 'title': 'Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.'}, {'id': 'BG002', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 10 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.'}, {'id': 'BG003', 'title': 'Text Messaging (TM) + Patient Navigation (PN) + 30 Day', 'description': 'Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.\n\nText-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.\n\nPatient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.\n\nIntervention message frequency is every 30 days for a total of 3 messages.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.43', 'spread': '16.31', 'groupId': 'BG000'}, {'value': '42.12', 'spread': '16.05', 'groupId': 'BG001'}, {'value': '42.02', 'spread': '16.13', 'groupId': 'BG002'}, {'value': '42.17', 'spread': '16.20', 'groupId': 'BG003'}, {'value': '42.18', 'spread': '16.17', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex', 'categories': [{'title': 'Female', 'measurements': [{'value': '4491', 'groupId': 'BG000'}, {'value': '4417', 'groupId': 'BG001'}, {'value': '4420', 'groupId': 'BG002'}, {'value': '4456', 'groupId': 'BG003'}, {'value': '17784', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3370', 'groupId': 'BG000'}, {'value': '3442', 'groupId': 'BG001'}, {'value': '3435', 'groupId': 'BG002'}, {'value': '3406', 'groupId': 'BG003'}, {'value': '13653', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'American Indian/Alaska Native', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}, {'value': '317', 'groupId': 'BG004'}]}, {'title': 'Black/African American', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '394', 'groupId': 'BG004'}]}, {'title': 'Hawaiian/Pacific Islander', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '205', 'groupId': 'BG004'}]}, {'title': 'Hispanic or Latino/a', 'measurements': [{'value': '4218', 'groupId': 'BG000'}, {'value': '4250', 'groupId': 'BG001'}, {'value': '4323', 'groupId': 'BG002'}, {'value': '4283', 'groupId': 'BG003'}, {'value': '17074', 'groupId': 'BG004'}]}, {'title': 'Multi-race', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '315', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '979', 'groupId': 'BG000'}, {'value': '974', 'groupId': 'BG001'}, {'value': '905', 'groupId': 'BG002'}, {'value': '941', 'groupId': 'BG003'}, {'value': '3799', 'groupId': 'BG004'}]}, {'title': 'White Non-Hispanic', 'measurements': [{'value': '2342', 'groupId': 'BG000'}, {'value': '2306', 'groupId': 'BG001'}, {'value': '2301', 'groupId': 'BG002'}, {'value': '2309', 'groupId': 'BG003'}, {'value': '9258', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Language', 'classes': [{'categories': [{'title': 'English', 'measurements': [{'value': '3834', 'groupId': 'BG000'}, {'value': '3798', 'groupId': 'BG001'}, {'value': '3808', 'groupId': 'BG002'}, {'value': '3772', 'groupId': 'BG003'}, {'value': '15212', 'groupId': 'BG004'}]}, {'title': 'Spanish', 'measurements': [{'value': '3398', 'groupId': 'BG000'}, {'value': '3415', 'groupId': 'BG001'}, {'value': '3429', 'groupId': 'BG002'}, {'value': '3463', 'groupId': 'BG003'}, {'value': '13705', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '347', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '541', 'groupId': 'BG000'}, {'value': '562', 'groupId': 'BG001'}, {'value': '545', 'groupId': 'BG002'}, {'value': '527', 'groupId': 'BG003'}, {'value': '2175', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Urban/Rural', 'classes': [{'categories': [{'title': 'Urban', 'measurements': [{'value': '7098', 'groupId': 'BG000'}, {'value': '7091', 'groupId': 'BG001'}, {'value': '7090', 'groupId': 'BG002'}, {'value': '7097', 'groupId': 'BG003'}, {'value': '28376', 'groupId': 'BG004'}]}, {'title': 'Rural', 'measurements': [{'value': '763', 'groupId': 'BG000'}, {'value': '769', 'groupId': 'BG001'}, {'value': '766', 'groupId': 'BG002'}, {'value': '765', 'groupId': 'BG003'}, {'value': '3063', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CHC', 'classes': [{'categories': [{'title': 'CHC 1', 'measurements': [{'value': '5280', 'groupId': 'BG000'}, {'value': '5281', 'groupId': 'BG001'}, {'value': '5279', 'groupId': 'BG002'}, {'value': '5284', 'groupId': 'BG003'}, {'value': '21124', 'groupId': 'BG004'}]}, {'title': 'CHC 2', 'measurements': [{'value': '884', 'groupId': 'BG000'}, {'value': '884', 'groupId': 'BG001'}, {'value': '882', 'groupId': 'BG002'}, {'value': '881', 'groupId': 'BG003'}, {'value': '3531', 'groupId': 'BG004'}]}, {'title': 'CHC 3', 'measurements': [{'value': '1697', 'groupId': 'BG000'}, {'value': '1695', 'groupId': 'BG001'}, {'value': '1695', 'groupId': 'BG002'}, {'value': '1697', 'groupId': 'BG003'}, {'value': '6784', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants from each CHC', 'unitOfMeasure': 'Participants'}, {'title': 'SCALE-UP I Randomization', 'classes': [{'categories': [{'title': 'Not enrolled in SCALE-UP I', 'measurements': [{'value': '2688', 'groupId': 'BG000'}, {'value': '2689', 'groupId': 'BG001'}, {'value': '2682', 'groupId': 'BG002'}, {'value': '2687', 'groupId': 'BG003'}, {'value': '10746', 'groupId': 'BG004'}]}, {'title': 'TM', 'measurements': [{'value': '2253', 'groupId': 'BG000'}, {'value': '2255', 'groupId': 'BG001'}, {'value': '2258', 'groupId': 'BG002'}, {'value': '2258', 'groupId': 'BG003'}, {'value': '9024', 'groupId': 'BG004'}]}, {'title': 'TM+PN', 'measurements': [{'value': '2920', 'groupId': 'BG000'}, {'value': '2916', 'groupId': 'BG001'}, {'value': '2916', 'groupId': 'BG002'}, {'value': '2917', 'groupId': 'BG003'}, {'value': '11669', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance Status', 'classes': [{'categories': [{'title': 'Private', 'measurements': [{'value': '1878', 'groupId': 'BG000'}, {'value': '1772', 'groupId': 'BG001'}, {'value': '1798', 'groupId': 'BG002'}, {'value': '1858', 'groupId': 'BG003'}, {'value': '7306', 'groupId': 'BG004'}]}, {'title': 'Public', 'measurements': [{'value': '1193', 'groupId': 'BG000'}, {'value': '1160', 'groupId': 'BG001'}, {'value': '1165', 'groupId': 'BG002'}, {'value': '1233', 'groupId': 'BG003'}, {'value': '4751', 'groupId': 'BG004'}]}, {'title': 'Uninsured', 'measurements': [{'value': '4790', 'groupId': 'BG000'}, {'value': '4928', 'groupId': 'BG001'}, {'value': '4893', 'groupId': 'BG002'}, {'value': '4771', 'groupId': 'BG003'}, {'value': '19382', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-05', 'size': 4981457, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-23T11:20', 'hasProtocol': True}, {'date': '2024-09-05', 'size': 39479, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-23T11:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients will not know what intervention arm they are in.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patient-level, two-arm randomized design for Population Health Management interventions: (1) TM + No PN and (2) TM + Request PN'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31439}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2022-09-07', 'resultsFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-15', 'studyFirstPostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reach-Accept Testing', 'timeFrame': 'Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]', 'description': 'Number of patients that accept an offer to receive an at-home test kit and verify mailing address'}], 'secondaryOutcomes': [{'measure': 'Reach-Engage Testing', 'timeFrame': 'Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]', 'description': 'Number of patients that reply to an offer to receive an at-home rapid test kit'}, {'measure': 'PN-Request', 'timeFrame': 'Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]', 'description': 'Number of PN participants that request a Patient Navigator.'}, {'measure': 'PN-Engage', 'timeFrame': 'Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]', 'description': 'Number of PN participants that speak to a Patient Navigator'}, {'measure': 'Opt-out', 'timeFrame': 'Daily [up to 90 days post intervention messaging)', 'description': 'Number of participants that opt out throughout the duration of the intervention'}, {'measure': 'Self Reported Testing', 'timeFrame': '90 days post intervention messaging', 'description': 'Participants who self-reported testing as completed. Reported only for participants who requested COVID-19 test kits from the study and responded to follow-up messages.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '40720824', 'type': 'DERIVED', 'citation': 'Del Fiol G, Kuzmenko TV, Orleans B, Chipman JJ, Greene T, Meads R, Kaphingst KA, Gibson B, Kawamoto K, King AJ, Siaperas T, Hughes S, Pruhs A, Dinkins CP, Lam CY, Pierce JH, Benson R, Borsato EP, Cornia RC, Stevens L, Bradshaw RL, Schlechter CR, Wetter DW. Population-Based Digital Health Interventions to Deliver at-Home COVID-19 Testing: SCALE-UP II Randomized Clinical Trial. J Med Internet Res. 2025 Jul 28;27:e74145. doi: 10.2196/74145.'}, {'pmid': '38508633', 'type': 'DERIVED', 'citation': 'Del Fiol G, Orleans B, Kuzmenko TV, Chipman J, Greene T, Martinez A, Wirth J, Meads R, Kaphingst KK, Gibson B, Kawamoto K, King AJ, Siaperas T, Hughes S, Pruhs A, Pariera Dinkins C, Lam CY, Pierce JH, Benson R, Borsato EP, Cornia R, Stevens L, Bradshaw RL, Schlechter CR, Wetter DW. SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres. BMJ Open. 2024 Mar 20;14(3):e081455. doi: 10.1136/bmjopen-2023-081455.'}]}, 'descriptionModule': {'briefSummary': 'The long-term objective of SCALE-UP II is to increase the reach, uptake, and sustainability of COVID-19 testing among underserved populations. Through RADx-UP Phase I funding (SCALE-UP Utah), the team has established population health management (PHM) interventions that have been used since Feb 2021 to increase the uptake of COVID-19 testing and vaccination among community health center patients.\n\nInterventions are based on a PHM approach that uses widely available technology (i.e. cell phones and text messaging). SCALE-UP II will both build on SCALE-UP Utah PHM interventions and investigate novel resource conservation approaches (i.e., Request-Patient Navigation vs. No Patient Navigation and text messaging vs. conversational agent).\n\nSCALE-UP II builds on long standing partnerships among the University of Utah Clinical and Translational Science Institute (UofU CTSI), Association for Utah Community Health (AUCH), CHCs, and the Utah Department of Health(UDOH). CTSI and SCALE-UP II investigators are leading several COVID-19 initiatives that drive public health response and state government policies in Utah.', 'detailedDescription': "Racial/ethnic minority, low socioeconomic status (SES), and rural populations suffer profound health inequities across a wide variety of diseases and conditions, including COVID-19. For example, as of June 2021, the cumulative COVID case rate in Utah per 100,000 was 10,803 among Whites vs. 17,541 among Latinos. The positivity rate was 14% among Whites vs. 24% among Latinos. Similar disparities persist across the nation for vaccination rates between urban vs. rural, high vs. low SES, and White vs. non-White populations. Low vaccination rates leave underserved populations at risk for local outbreaks, and more contagious and severe variants. Thus, interventions targeting these populations at the interplay between testing and vaccination among underserved populations are critical for pandemic control.\n\nNot only do underserved populations experience profound health inequities, but there is also a critical digital divide between high and low resource healthcare systems. Low resource settings are far less likely to adopt Health Information Technology approaches, and often do not have the capacity to implement large scale population health management (PHM) efforts utilizing data analytics and automated patient outreach. As such, research is needed utilizing targeted PHM approaches that proactively identify, reach, and navigate vulnerable patients to both increase opportunities to engage in vaccination and testing, and to address barriers to engagement. Community Health Centers (CHCs) are optimal settings for implementation of PHM interventions to increase the uptake of COVID-19 testing and vaccination among underserved populations. Eleven Utah CHC systems are participating in SCALE-UP II. Their 38 primary care clinics serve over 112,000 unique patients annually (36% Latino, 10% Native American, 63% \\<100% poverty level, 57% uninsured, and 42% of clinics are in rural/frontier areas).\n\nSCALE UP II is comprised of two distinct studies, the Text Message (TM) study and the Conversational Agent (CA) study. Patients will be triaged into one of two studies based on self-reported ownership of a smart phone with internet access. Patients who report not owning a smart phone with internet access will be included in the TM study. Additionally, patients who do not respond to the question regarding smart phone ownership will be included in the TM study. Patients who self-report ownership of a smart phone with internet access will be included in the CA study.\n\nSCALE-UP II: TM study will implement and evaluate practical, accessible, and scalable PHM interventions to increase COVID-19 testing and vaccine uptake based on the best evidence available, patients' specific barriers and hesitancy factors, and extensive collaboration with CHCs, AUCH, and UDHHS. This study is a 1x2 design with all patients receiving text messages as well as either type of available patient navigation.\n\nText Messaging (TM): bidirectional text messaging to connect patients to vaccination or mailed at-home rapid test kits for use, as needed.\n\nPatient Navigation (PN): phone call from a community health worker to help address hesitancy and barriers, and to offer at-home rapid test kits. This study will examine two distinct forms of Patient Navigation: Request-PN and No PN. Each patient will be randomized to receive either Request PN or No PN. Request PN allows patients to request patient navigation by responding PERSON to a text message. Patients who are randomized to receive No PN will not be provided the opportunity to speak with a patient navigator.\n\nThis study examined the main effects for PN (PN \\& No PN) and message frequency (10-day \\& 30-day). Vaccine response was not examined.\n\nThe primary outcome, Reach-Accept Testing, captures the proportion of participants who request a test and confirm their mailing address. Secondary outcomes include: Reach-Engage Testing (proportion of patients that reply to an offer to receive an at-home rapid test kit), Patient Navigation- Request (proportion of PN participants that request a patient navigator), Patient Navigation-Engage (proportion of PN participants that speak to a patient navigator) and Self-reported testing (participants that request a COVID-19 test kit and respond to follow up messaging).\n\nSCALE-UP II will include a Consortium Data Reporting Unit (CDRU) consisting of a Data Manager and one member the project's biomedical informatics team. The unit will attend regular meetings and dissemination activities organized by the CDCC. The CDRU will seek guidance from the CDCC with regard to data acquisition and consent for data sharing. As required by the NIH, SCALE-UP II will collect RADx-UP Tier 1 Common Data Elements for study participants who receive an at-home COVID test through the project. These data will be collected through surveys administered one month after the participant receives their at-home test. Data will be standardized according to the data dictionary provided by the CDCC. Our CDRU will work closely with the CDCC to establish a protocol for frequency, format, and exchange of data. SCALE-UP II will share identifiable data with the CDCC and NIH for the Data Hub as well as future research. Participants who complete the survey data will first complete an informed consent process. The informed consent will be administered to the patient at the time of survey collection.\n\nLighthouse Research and Development will conduct phone surveys to assess patient reported use of COVID-19 at-home testing (\\~2,300 participants) among patients who received test kits and do no respond to the online survey request. Lighthouse will send notifications (e.g., postcards, text messages, voice messages, etc.) to participants to alert them of the opportunity to complete the survey online or over the phone. Interviewers will complete up to 15 call attempts across weekday, evening, and weekend calling shifts over a one-month period to each participant. Patients will be compensated with a gift card for completing the survey. Patients will be compensated with a gift card for completing the survey."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* current patient of a participating community health center\n* have a working cellphone,\n* have phone number listed in existing electronic medical record at their participating clinic\n* speak English or Spanish.\n\nExclusion Criteria:\n\n\\- Minors'}, 'identificationModule': {'nctId': 'NCT05533918', 'briefTitle': 'SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Text Message Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Testing and Vaccination Among Utah Community Health Centers', 'orgStudyIdInfo': {'id': '00150669'}, 'secondaryIdInfos': [{'id': 'U01MD017421', 'link': 'https://reporter.nih.gov/quickSearch/U01MD017421', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Text Messaging (TM) + No Patient Navigation', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to vaccination or mailed at-home rapid test kits for use as needed.\n\nPatients will not receive patient navigation.', 'interventionNames': ['Behavioral: Text-Messaging (TM)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Text Message (TM) + Request (RPN)', 'description': 'Bidirectional text messaging with a one-touch response to connect patients to vaccination or mailed at-home rapid test kits for use as needed.\n\nRPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.', 'interventionNames': ['Behavioral: Text-Messaging (TM)', 'Behavioral: Patient Navigation (PN)']}], 'interventions': [{'name': 'Text-Messaging (TM)', 'type': 'BEHAVIORAL', 'description': 'Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.', 'armGroupLabels': ['Text Message (TM) + Request (RPN)', 'Text Messaging (TM) + No Patient Navigation']}, {'name': 'Patient Navigation (PN)', 'type': 'BEHAVIORAL', 'description': 'Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.\n\nThere are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.', 'armGroupLabels': ['Text Message (TM) + Request (RPN)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Guilherme Del Fiol, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Utah Department of Health', 'class': 'OTHER'}, {'name': 'Association for Utah Community Health', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guilherme Del Fiol', 'investigatorAffiliation': 'University of Utah'}}}}