Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-25 @ 12:37 PM
Study NCT ID:
NCT04542395
Status:
WITHDRAWN
Last Update Posted:
2022-08-19
First Post:
2020-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-2019 Testing and Vaccination Among African American and Latinx Public Housing Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014611', 'term': 'Vaccination'}], 'ancestors': [{'id': 'D016233', 'term': 'Immunotherapy, Active'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study not funded', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2020-09-04', 'lastUpdatePostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of COVID-19 testing, pneumococcal and influenza vaccinations Using Test History Self-Report', 'timeFrame': 'Intervention: 3 months; Follow-up Point: 6 months post-intervention', 'description': 'By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 30% change in willingness and uptake for testing and vaccination.'}, {'measure': 'Percentage of Participants Achieving Decreased Levels of COVID-19 Risk Using the NIH Toolbox Surveys on COVID-19', 'timeFrame': 'Intervention: 3 months; Follow-up Point: 6 months post-intervention', 'description': 'By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 30% change in perceived COVID-19 risk.'}, {'measure': 'Percentage of Participants Achieving Decreased Levels of COVID-19 Mistrust and Barriers Using the NIH Toolbox Surveys on COVID-19', 'timeFrame': 'Intervention: 3 months; Follow-up Point: 6 months post-intervention', 'description': 'By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 40% change in mistrust and perceived barriers toward COVID-19 testing and vaccination,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus']}, 'descriptionModule': {'briefSummary': 'This proposal seeks to enhance acceptability and uptake of COVID-19 testing and vaccination to engage African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to reduce barriers and implement innovate strategies to engage this population in the uptake of COVID-19 testing and vaccination.', 'detailedDescription': 'Through the engagement and empowerment of 15 trained COVID-19 health ambassadors, the investigators will jointly implement and evaluate a theoretically based and culturally-sensitive socio-behavioral intervention that will: a) reduce mistrust, fatalistic beliefs, and related psychosocial barriers that hinder COVID-19 testing and vaccination; b) increase receptivity and willingness for uptake of COVID-19 testing and vaccination; and c) assess perceived impact of psychosocial and health outcomes related to COVID-19 testing and vaccination for 310 African American and Latinx public housing residents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identify as Latino/Hispanic or African American/Black\n* Reside in one of the six collaborating public housing\n* 18 years old and older\n* Speak either English or Spanish\n\nExclusion Criteria:\n\n* Does not self-identify as African American and/or Black\n* Under the age of 18\n* Unable to speak English or Spanish\n* Does not Reside in one of the six collaborating public housing'}, 'identificationModule': {'nctId': 'NCT04542395', 'briefTitle': 'COVID-2019 Testing and Vaccination Among African American and Latinx Public Housing Residents', 'organization': {'class': 'OTHER', 'fullName': 'Charles Drew University of Medicine and Science'}, 'officialTitle': 'Multilevel Participatory Intervention to Reduce Barriers and Promote Social and Behavioral Facilitators of COVID-19 Testing Among African Americans and Latinx Public Housing Residents', 'orgStudyIdInfo': {'id': 'COVID19testingvacc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Increasing Uptake of COVID-19 Testing and Vaccination', 'description': 'This is a pre-experimental "one group pretest-posttest" design to improve COVID-19 associated health outcomes and willingness and uptake toward testing and vaccination among 310 Hispanic and African American public housing residents in South Los Angeles. The proposed intervention will employ (1) culturally sensitive, (2) theoretically based intervention that will be jointly delivered by our COVID-19 health ambassadors and our researchers. We will use the Information, Motivation, and Behavioral Skills (IMB) model and the Transtheoretical Model to implement the intervention.', 'interventionNames': ['Behavioral: Increasing Willingness and Uptake of COVID-19 Testing and Vaccination']}], 'interventions': [{'name': 'Increasing Willingness and Uptake of COVID-19 Testing and Vaccination', 'type': 'BEHAVIORAL', 'description': 'Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 related risk and challenges and increase willingness and uptake in COVID-19 testing and vaccination.', 'armGroupLabels': ['Increasing Uptake of COVID-19 Testing and Vaccination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90059', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Housing Authority of Clty of Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Mohsen Bazargan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles R. Drew University of Medicine & Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles Drew University of Medicine and Science', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}