Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 3:54 PM
Study NCT ID:
NCT04939506
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2021-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in SE Louisiana
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-03-17', 'unreleaseDate': '2025-03-21'}, {'resetDate': '2025-04-22', 'releaseDate': '2025-04-02'}], 'estimatedResultsFirstSubmitDate': '2025-03-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000072758', 'term': 'Vaccination Refusal'}, {'id': 'D000088823', 'term': 'Vaccination Hesitancy'}], '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'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 379}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 Vaccine Completion', 'timeFrame': '9 months intervention', 'description': 'COVID-19 vaccination verified by the Louisiana Links© system'}], 'secondaryOutcomes': [{'measure': 'Vaccine Hesitancy Likelihood Scale', 'timeFrame': '9 months post intervention', 'description': 'Measured on a 5-point scale indicating likelihood to be vaccinated. The scale ranges from 1 (Not at all likely to be vaccinated), 2 (Not likely to be vaccinated), 3 (No opinion/Undecided about vaccination), 4 (Likely to be vaccinated) to 5 (Very likely to be vaccinated)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaccine Completion', 'COVID19 Testing', 'COVID19 Education', 'Point of Care Testing', 'Healthcare Personnel Education', 'Healthcare Disparities'], 'conditions': ['Covid19', 'Vaccine Refusal', 'Vaccine Hesitancy']}, 'descriptionModule': {'briefSummary': 'This project is a 2-year study to investigate vaccine hesitancy and vaccine completion among vulnerable communities in the Southeastern Louisiana region. This study will be used to track COVID-19 vaccine completion among patients who seek testing, either as in-person or purchasing at home COVID testing, from pharmacies, urgent cares and clinics using a rapid vaccine education model delivered at the point of care.', 'detailedDescription': "This project is a 2-year study to investigate vaccine hesitancy and vaccine completion among vulnerable communities in the Southeastern Louisiana region. This study will be used to track COVID-19 vaccine completion among patients who seek testing, either as in-person or purchasing at home COVID testing, from pharmacies, urgent cares and clinics. The proposal will introduce a rapid vaccination education model to be delivered at the point of COVID-19 testing by pharmacy students, pharmacy technicians, nurse's aides and other health care personnel and includes monitoring for COVID-19 vaccine completion among enrolled patients. Investigators anticipate an increase in COVID-19 vaccine completion rates for those who participate in the rapid vaccination education model."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unvaccinated adult participants, 18-99 years of age, able to provide informed consent, and to communicate in English, Spanish or Arabic. Also, individuals with incomplete vaccination (primary series or COVID-19 booster).\n\nExclusion Criteria:\n\n* Persons fully vaccinated for COVID-19 (including primary series and boosters), persons with any documented allergies to components of the COVID-19 vaccines, or contraindications to receiving a COVID-19 vaccine.'}, 'identificationModule': {'nctId': 'NCT04939506', 'briefTitle': 'COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in SE Louisiana', 'organization': {'class': 'OTHER', 'fullName': 'Xavier University of Louisiana.'}, 'officialTitle': 'COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in Southeastern Louisiana', 'orgStudyIdInfo': {'id': 'IRB850-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants Which Receive COVID-19 Vaccine Education at the Point of COVID-19 Testing', 'description': 'Vaccine education will be focused on addressing misinformation and concerns in a culturally competent manner with referral to resources. The vaccine education model will be translated to reach minority groups including African Americans, Vietnamese Americans and Hispanic Americans.', 'interventionNames': ['Behavioral: COVID-19 Vaccine Education at the Point of COVID-19 Testing']}], 'interventions': [{'name': 'COVID-19 Vaccine Education at the Point of COVID-19 Testing', 'type': 'BEHAVIORAL', 'description': "A rapid vaccination education model to be delivered at the point of COVID-19 testing by pharmacy students, pharmacy technicians, nurse's aides and other health care personnel. The intervention will include: 1) 15 minute vaccine counseling, 2) print material 3) referral to a dedicated vaccine website with feedback forums and 4) opportunity to sign-up for one-on-one vaccine counseling with a clinical pharmacist", 'armGroupLabels': ['Participants Which Receive COVID-19 Vaccine Education at the Point of COVID-19 Testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70125', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Xavier University of Louisiana', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Sara Al-Dahir, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xavier University of Louisiana.'}, {'name': 'Klaus Heyer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nunez Community College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xavier University of Louisiana.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-17', 'type': 'RELEASE'}, {'date': '2025-03-21', 'type': 'UNRELEASE'}, {'date': '2025-04-02', 'type': 'RELEASE'}, {'date': '2025-04-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Xavier University of Louisiana.'}}}}