Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 9:35 PM
Study NCT ID:
NCT06146361
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2023-11-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vale+Tú Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19
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': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Maria.E.Fernandez-Esquer@uth.tmc.edu', 'phone': '713-500-9657', 'title': 'Maria E. Fernandez-Esquer, PhD', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 30 days', 'eventGroups': [{'id': 'EG000', 'title': 'COVID-19 Group Problem Solving', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group Problem Solving Plus Booster Session', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only\n\nBooster session: Participants will have a 10 - 15 minute "booster\' session about a week after engaging in the small group intervention.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Standard of Care', 'description': 'Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 0, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Group Problem Solving', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}, {'id': 'OG001', 'title': 'Group Problem Solving Plus Booster Session', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only\n\nBooster session: Participants will have a 10 - 15 minute "booster\' session about a week after engaging in the small group intervention.'}, {'id': 'OG002', 'title': 'Standard of Care', 'description': 'Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Measure of compliance with COVID vaccination guidelines.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Group Problem Solving', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}, {'id': 'OG001', 'title': 'Group Problem Solving Plus Booster Session', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only\n\nBooster session: Participants will have a 10 - 15 minute "booster\' session about a week after engaging in the small group intervention.'}, {'id': 'OG002', 'title': 'Standard of Care', 'description': 'Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks post intervention', 'description': 'Post test measure of compliance with COVID vaccination guidelines.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 16 in the Group Problem Solving arm, for 20 in the Group Problem Solving plus Booster Session arm, and 24 in the Standard of Care arm--this is because these participants were lost to follow up at the 4-week timepoint.'}, {'type': 'PRIMARY', 'title': 'Mask Wearing Frequency as Assessed by a Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Group Problem Solving', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}, {'id': 'OG001', 'title': 'Group Problem Solving Plus Booster Session', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only\n\nBooster session: Participants will have a 10 - 15 minute "booster\' session about a week after engaging in the small group intervention.'}, {'id': 'OG002', 'title': 'Standard of Care', 'description': 'Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}], 'classes': [{'categories': [{'measurements': [{'value': '2.050', 'spread': '0.915', 'groupId': 'OG000'}, {'value': '2.109', 'spread': '0.836', 'groupId': 'OG001'}, {'value': '1.927', 'spread': '0.842', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected for 2 in the Group Problem Solving arm and for 4 in the Group Problem Solving plus Booster Session arm--this is because these participants did not complete this survey.'}, {'type': 'PRIMARY', 'title': 'Mask Wearing Frequency as Assessed by a Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Group Problem Solving', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}, {'id': 'OG001', 'title': 'Group Problem Solving Plus Booster Session', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only\n\nBooster session: Participants will have a 10 - 15 minute "booster\' session about a week after engaging in the small group intervention.'}, {'id': 'OG002', 'title': 'Standard of Care', 'description': 'Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}], 'classes': [{'categories': [{'measurements': [{'value': '1.720', 'spread': '0.621', 'groupId': 'OG000'}, {'value': '1.798', 'spread': '0.567', 'groupId': 'OG001'}, {'value': '1.632', 'spread': '0.673', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks post intervention', 'description': 'Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected for 16 in the Group Problem Solving arm, for 20 in the Group Problem Solving plus Booster Session arm, and for 24 in the Standard of Care arm--this is because these participants were lost to follow up at the 4-week timepoint.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Contacted an Agency About the Gold Card', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Group Problem Solving', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}, {'id': 'OG001', 'title': 'Group Problem Solving Plus Booster Session', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only\n\nBooster session: Participants will have a 10 - 15 minute "booster\' session about a week after engaging in the small group intervention.'}, {'id': 'OG002', 'title': 'Standard of Care', 'description': 'Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks post intervention', 'description': 'Percentage of participants who reported contacting a local community or health agency to request the Gold Card a local medical insurance for low income individuals living in Harris County.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this outcome measure, data were collected only for those who called a number on the resource sheet--for the Group Problem Solving arm, 20 called a number; for the Group Problem Solving plus Booster Session arm, 22 called a number; and for the Standard of Care arm, 7 called a number.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Reported Contacting the Agency for Assistance to Get Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Group Problem Solving', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}, {'id': 'OG001', 'title': 'Group Problem Solving Plus Booster Session', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only\n\nBooster session: Participants will have a 10 - 15 minute "booster\' session about a week after engaging in the small group intervention.'}, {'id': 'OG002', 'title': 'Standard of Care', 'description': 'Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks post intervention', 'description': 'Percentage of participants who reported seeking food assistance from a local community organization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this outcome measure, data were collected only for those who called a number on the resource sheet--for the Group Problem Solving arm, 20 called a number; for the Group Problem Solving plus Booster Session arm, 22 called a number; and for the Standard of Care arm, 7 called a number.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Group Problem Solving', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}, {'id': 'OG001', 'title': 'Group Problem Solving Plus Booster Session', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only\n\nBooster session: Participants will have a 10 - 15 minute "booster\' session about a week after engaging in the small group intervention.'}, {'id': 'OG002', 'title': 'Standard of Care', 'description': 'Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks post intervention', 'description': 'Percentage of participants who reported seeking medical assistance or health advice from a local clinic or community organization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this outcome measure, data were collected only for those who called a number on the resource sheet--for the Group Problem Solving arm, 20 called a number; for the Group Problem Solving plus Booster Session arm, 22 called a number; and for the Standard of Care arm, 7 called a number.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COVID-19 Group Problem Solving', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}, {'id': 'FG001', 'title': 'Group Problem Solving Plus Booster Session', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only\n\nBooster session: Participants will have a 10 - 15 minute "booster\' session about a week after engaging in the small group intervention.'}, {'id': 'FG002', 'title': 'Standard of Care', 'description': 'Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '120'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '120'}, {'groupId': 'FG002', 'numUnits': '8', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '104'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '100'}, {'groupId': 'FG002', 'numUnits': '8', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '16'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '20'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '24'}]}]}], 'typeUnitsAnalyzed': 'street corners'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'COVID-19 Group Problem Solving', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}, {'id': 'BG001', 'title': 'Group Problem Solving Plus Booster Session', 'description': 'COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.\n\nStandard of Care: This group will receive a COVID-19 prevention flyer and social resources list only\n\nBooster session: Participants will have a 10 - 15 minute "booster\' session about a week after engaging in the small group intervention.'}, {'id': 'BG002', 'title': 'Standard of Care', 'description': 'Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '353', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '43.4', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '43.7', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '40.3', 'spread': '14.3', 'groupId': 'BG002'}, {'value': '42.5', 'spread': '13.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'For age, data were not collected for 2 in the Group Problem Solving arm, for 2 in the Group Problem Solving Plus Booster Session arm, and for 2 in the Standard of Care arm.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-01', 'size': 808139, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-04T16:49', 'hasProtocol': True}, {'date': '2023-05-01', 'size': 271037, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-04T17:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster Randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 359}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2023-11-22', 'resultsFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2023-11-22', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-03', 'studyFirstPostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey', 'timeFrame': 'Baseline', 'description': 'Measure of compliance with COVID vaccination guidelines.'}, {'measure': 'Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey', 'timeFrame': '4 weeks post intervention', 'description': 'Post test measure of compliance with COVID vaccination guidelines.'}, {'measure': 'Mask Wearing Frequency as Assessed by a Survey', 'timeFrame': 'Baseline', 'description': 'Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.'}, {'measure': 'Mask Wearing Frequency as Assessed by a Survey', 'timeFrame': '4 weeks post intervention', 'description': 'Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.'}, {'measure': 'Percentage of Participants Who Contacted an Agency About the Gold Card', 'timeFrame': '4 weeks post intervention', 'description': 'Percentage of participants who reported contacting a local community or health agency to request the Gold Card a local medical insurance for low income individuals living in Harris County.'}, {'measure': 'Percentage of Participants Who Reported Contacting the Agency for Assistance to Get Food', 'timeFrame': '4 weeks post intervention', 'description': 'Percentage of participants who reported seeking food assistance from a local community organization.'}, {'measure': 'Percentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources', 'timeFrame': '4 weeks post intervention', 'description': 'Percentage of participants who reported seeking medical assistance or health advice from a local clinic or community organization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Latino Day Laborers'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identify as Hispanic or Latino\n* Be present at the corner for the purposes of looking for work\n\nExclusion Criteria:\n\n* Have not been previously hired to work at a corner\n* Symptoms of COVID-19 in the previous 48 hours'}, 'identificationModule': {'nctId': 'NCT06146361', 'briefTitle': 'Vale+Tú Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Vale+ Tu Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19.', 'orgStudyIdInfo': {'id': 'HSC-SPH-20-1389 (phase 2)'}, 'secondaryIdInfos': [{'id': '1R01MD016328-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01MD016328-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COVID-19 Group Problem Solving', 'interventionNames': ['Behavioral: COVID-19 Group Problem Solving', 'Behavioral: Standard of Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'interventionNames': ['Behavioral: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Group Problem Solving Plus Booster Session', 'interventionNames': ['Behavioral: COVID-19 Group Problem Solving', 'Behavioral: Standard of Care', 'Behavioral: Booster session']}], 'interventions': [{'name': 'COVID-19 Group Problem Solving', 'type': 'BEHAVIORAL', 'description': 'This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers\' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.', 'armGroupLabels': ['COVID-19 Group Problem Solving', 'Group Problem Solving Plus Booster Session']}, {'name': 'Standard of Care', 'type': 'BEHAVIORAL', 'description': 'This group will receive a COVID-19 prevention flyer and social resources list only', 'armGroupLabels': ['COVID-19 Group Problem Solving', 'Group Problem Solving Plus Booster Session', 'Standard of Care']}, {'name': 'Booster session', 'type': 'BEHAVIORAL', 'description': 'Participants will have a 10 - 15 minute "booster\' session about a week after engaging in the small group intervention. They will be contacted by phone and the booster will consist of brief prompts to engage participants in a discussion to encourage them to act on their personal commitments to protect themselves and others against COVID. They will also be encouraged to seek COVID related resources based on the information provided during the small group intervention.', 'armGroupLabels': ['Group Problem Solving Plus Booster Session']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Maria E Fernandez-Esquer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Maria Eugenia Fernandez-Esquer', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}