Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT04501458
Status:
UNKNOWN
Last Update Posted:
2021-09-22
First Post:
2020-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Western Kenya Integrated COVID-19 Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D003150', 'term': 'Community Health Workers'}], 'ancestors': [{'id': 'D000488', 'term': 'Allied Health Personnel'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2020-08-05', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '3 months', 'description': 'Mortality related to COVID-19'}, {'measure': 'Number of confirmed COVID-19 cases in Siaya', 'timeFrame': '3 months', 'description': 'Number of confirmed COVID-19 cases in Siaya'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['youth, community health, digital tools, capacity building'], 'conditions': ['Covid19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://wellcomeopenresearch.org/articles/6-15/v1', 'label': 'Full protocol'}]}, 'descriptionModule': {'briefSummary': 'To respond to the COVID-19 pandemic, investigators will be deploying community health workers, equipped with mobile technology, and accompanied by youth to visit households door to door to screen for symptoms of COVID-19, isolate, test, and manage suspected cases of COVID-19. The community health workers and youth will educate households about preventive measures including frequent handwashing and home management of mild cases. Simultaneously, investigators will work with nurses, doctors, and clinical officers, to test and treat more severe cases of COVID-19 in health facilities. Our goals are: to visit every household in Siaya county covering a population of close to 1 million, and to train and support health workers working in 32 health facilities with oxygen capacity in Siaya to reduce the morbidity and mortality related to COVID19 and other conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Youth aged 18 to 30 years old.\n* Active community health workers.\n* Facilities with oxygen capacity.\n\nExclusion Criteria:\n\n* Individuals younger than 18 or older than 30 years old.\n* Inactive community health workers.\n* Facilities without oxygen capacity.'}, 'identificationModule': {'nctId': 'NCT04501458', 'briefTitle': 'Western Kenya Integrated COVID-19 Response', 'organization': {'class': 'OTHER', 'fullName': 'Surgical Systems Research Group'}, 'officialTitle': 'Western Kenya Integrated COVID-19 Response Leveraging the Community Health Strategy, Youth, and Technology to Flatten the COVID-19 Curve and Improve COVID-19 Case Detection, Isolation and Management in Western Kenya', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional community health units', 'description': 'Community health units with active community health workers.', 'interventionNames': ['Other: Training of youth, community health assistants and community health workers.']}, {'type': 'NO_INTERVENTION', 'label': 'Non functional community health units', 'description': 'Community health units without active community health workers.'}, {'type': 'EXPERIMENTAL', 'label': 'Health facilities with oxygen capacity', 'description': 'Health facility with regular oxygen capacity.', 'interventionNames': ['Other: Training clinicians in basic critical care and the management of severe COVID-19 cases']}, {'type': 'NO_INTERVENTION', 'label': 'Health facilities without oxygen capacity'}], 'interventions': [{'name': 'Training of youth, community health assistants and community health workers.', 'type': 'OTHER', 'description': 'Training of youth, community health assistants, and community health workers in the screening, detection, contact tracing, prevention, and management of COVID-19 with concurrent maintenance of essential health services.', 'armGroupLabels': ['Functional community health units']}, {'name': 'Training clinicians in basic critical care and the management of severe COVID-19 cases', 'type': 'OTHER', 'description': 'Training clinicians in basic critical care and the management of severe COVID-19 cases with concurrent maintenance of essential health services.', 'armGroupLabels': ['Health facilities with oxygen capacity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'country': 'Kenya', 'facility': 'Surgical Systems Research Group/Tropical Institute of Community Health', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}], 'overallOfficials': [{'name': 'Neema Kaseje, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Surgical Systems Research Group'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Immediately following publication; indefinitely.', 'ipdSharing': 'YES', 'description': 'De-identified participant data will be available when results are reported.', 'accessCriteria': 'Anyone with an approved proposal who wishes to access the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Surgical Systems Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wellcome Trust', 'class': 'OTHER'}, {'name': 'Tropical Institute of Community Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Founding Director', 'investigatorFullName': 'Neema Kaseje', 'investigatorAffiliation': 'Surgical Systems Research Group'}}}}