Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-28 @ 4:37 AM
Study NCT ID:
NCT04761692
Status:
WITHDRAWN
Last Update Posted:
2022-08-19
First Post:
2021-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D000072758', 'term': 'Vaccination Refusal'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'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'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D016312', 'term': 'Treatment Refusal'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The VEPMP will consist of recruited churches in 15 cohorts of 2 churches per cohort (total n = 30). Each cohort of church will include an AA and a Latinx church. The 15 church cohorts will be randomized to three arms based on a 1:1:1 ratio, using an online random number generator.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study not funded', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report', 'timeFrame': 'Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention', 'description': 'By comparison of pre-, post- intervention, and 9- and 18-months follow-up data, we anticipate the following compared to baseline: a 30% change in uptake for vaccination.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Adherence to COVID-19, influenza, and pneumonia vaccination schedules Risk Using the NIH Toolbox Surveys on COVID-19', 'timeFrame': 'Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention', 'description': 'By comparison of pre-, post- intervention, and 9 and 18-months follow-up data, we anticipate the following compared to baseline: a 30% change in adherence to COVID-19, influenza, and pneumonia vaccination schedules.'}, {'measure': 'Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of COVID-19, influenza, and pneumonia Using the NIH Toolbox Surveys on COVID-19, influenza, and pneumonia', 'timeFrame': 'Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention', 'description': 'By comparison of pre-, post- intervention, and 9 and 18-months follow-up data, we anticipate the following compared to baseline: a 40% change in vaccine hesitancy toward COVID-19, influenza, and pneumonia vaccination'}, {'measure': 'Percentage of Participants Achieving Decreased Levels of COVID-19, influenza, and pneumonia Mistrust and Barriers Using the NIH Toolbox Surveys on COVID-19, influenza, and pneumonia', 'timeFrame': 'Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention', 'description': 'By comparison of pre-, post- intervention, and 9 and 18-months follow-up data, we anticipate the following compared to baseline: a 40% change in mistrust and perceived barriers toward COVID-19, influenza, and pneumonia vaccination'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['African American', 'Latinx', 'Vaccine', 'Hispanic', 'Latino', 'COVID19 Vaccine'], 'conditions': ['Covid19', 'Influenza', 'Pneumonia', 'Vaccine Refusal']}, 'descriptionModule': {'briefSummary': 'This proposed study seeks to community knowledge and understand the experience of underserved communities in the exploration of reducing health disparities and increasing vaccine uptake and acceptability COVID-19, influenza, and pneumonia for AA and Latinx populations. Unique in its design, it has the following characteristics: 1) multifaceted, 2) culturally tailored, 3) community-based, and 4) mixed methods in which the outcomes of interest will be measured before and after the intervention with 18-month interval. Furthermore, we seek to enhance our partnerships and collaborations with churches in South Los Angeles by supporting efforts to encourage COVID-19, influenza, and pneumonia vaccination uptake among underserved minorities in one of the most challenged and hard-to-reach population areas in the nation.', 'detailedDescription': 'This study seeks to augment community knowledge and increase vaccine uptake among under-resourced African American and Latinx communities in South LA via leveraging trusted church leaders, educators and influencers to delivering COVID-19, influenza, and pneumonia education on vaccination. Unique in its design, this study has the following characteristics, beneficial to the acceptability and success of the proposal, it is: 1) multifaceted, 2) culturally tailored, and 3) community-based, in which the outcomes of interest will be compared longitudinally between arms 1-3, including measurement before and after the intervention with 9- and 18-month interval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parishioner at a church receiving the VEPMP intervention\n* Identify as African American or Latinx,\n* at least 65 years and older\n* Have Not received a vaccine for COVID-19, influenza, or pneumonia within the previous 24 months\n* Agrees to study terms, which include follow-up interviews 9 and 18 months after study enrollment\n\nExclusion Criteria:\n\n* Does not attend or identify as a Parishioner at a church receiving the VEPMP intervention\n* Does not identify as African American or Latinx\n* Under the age of 65 years\n* Received all vaccine doses for COVID-19, influenza, or pneumonia within the previous 24 months'}, 'identificationModule': {'nctId': 'NCT04761692', 'briefTitle': 'Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake', 'organization': {'class': 'OTHER', 'fullName': 'Charles Drew University of Medicine and Science'}, 'officialTitle': 'Improving Vaccine Acceptance and Uptake Among Underresourced African American and Latinx Older Adults: A Multidisciplinary and Culturally Based Training Program for Minority Churches', 'orgStudyIdInfo': {'id': 'vaccineinc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'This arm will include 5 churches who will receive all study activities in the Vaccine Education Promotion Management Plan', 'interventionNames': ['Behavioral: Full VEPMP Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'This arm will include 5 churches who will receive some study activities in the Vaccine Education Promotion Management Plan', 'interventionNames': ['Behavioral: Partial VEPMP Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'This arm will include 5 churches who will receive all study activities in the Vaccine Education Promotion Management Plan following completion of Arm 1 and 2.', 'interventionNames': ['Behavioral: Delayed VEPMP Intervention']}], 'interventions': [{'name': 'Full VEPMP Intervention', 'type': 'BEHAVIORAL', 'description': 'Delivery of intrapersonal/interpersonal (i.e., motivational interviewing, vaccine educators, personal testimony, etc.), AND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.)', 'armGroupLabels': ['Arm 1']}, {'name': 'Partial VEPMP Intervention', 'type': 'BEHAVIORAL', 'description': 'Delivery of iAND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.)', 'armGroupLabels': ['Arm 2']}, {'name': 'Delayed VEPMP Intervention', 'type': 'BEHAVIORAL', 'description': 'Delayed implementation of delivery of intrapersonal/interpersonal AND organizational after 1 year of study start', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90059', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Charles R. Drew University of Medicine & Science', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Mohsen Bazargan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles R. Drew University of Medicine & Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles Drew University of Medicine and Science', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}