Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT06075732
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2023-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ACTIVATE in Public Housing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-02-27', 'unreleaseDate': '2025-02-27'}], 'estimatedResultsFirstSubmitDate': '2025-02-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000088823', 'term': 'Vaccination Hesitancy'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D000072758', 'term': 'Vaccination Refusal'}, {'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': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2023-10-04', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of vaccination uptake for Influenza, Pneumonia, Meningitis, VZV, and COVID-19 using Vaccination History Self Report', 'timeFrame': 'Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention', 'description': 'By comparison of pre-, post- intervention, and 9- and 18-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in completion of Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination series'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccine Using the NIH Toolbox Surveys on COVID-19', 'timeFrame': 'Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention', 'description': 'By comparison of pre-, post- intervention, and 3- and 9-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in hesitancy toward Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination'}, {'measure': 'Percentage of Participants Achieving Increased Level of Behavior Change toward COVID-19 Vaccination Using the NIH Toolbox Surveys on Influenza, Pneumonia, Meningitis, VZV, and COVID-19', 'timeFrame': 'Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention', 'description': 'By comparison of pre-, post- intervention, and 3- and 9-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in their behavior stage of change toward Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia', 'Influenza', 'Varicella Zoster', 'Meningitis', 'COVID-19', 'Vaccine Hesitancy']}, 'descriptionModule': {'briefSummary': 'This multilevel, multidisciplinary, theoretically based, culturally sensitive, community-engaged intervention sets out to mitigate uptake barriers and non-adherence to vaccination schedules as recommended by the CDC and increase influenza, meningitis, pneumonia, VZV, and COVID-19 vaccine rates among under-resourced African American and Latino public housing residents in South Los Angeles.', 'detailedDescription': 'Vaccinations are critical for preventing infectious diseases such as influenza, meningitis, pneumonia, varicella zoster virus (VZV), and COVID-19. Despite increasing national distribution and promotion of routine recommendations for adult vaccination, coverage remains low, with historically lower uptake among racial and ethnic minorities. This is compounded by higher levels of vaccine hesitancy, which may be attributed to a myriad of issues, including worsening social determinants, medical mistrust, and lack of access to health services. Specifically, African American and Latino public housing residents may benefit from public health campaigns and vaccination initiatives to support high vaccine uptake and confidence. This R01 proposal seeks to expand on a proven, multilevel, multidisciplinary, theoretically based, culturally sensitive, community-engaged intervention by expanding the Academic-Community Team for Improving Vaccine Acceptability and Targeted Engagement (ACTIVATE) program. Guided by a fusion of the Social-Ecological framework (SEM) and the Practical, Robust Implementation and Sustainability Model (PRISM), the ACTIVATE program is inclusive of health factors on the individual, interpersonal, community, and societal level and elements for successful implementation. Led by leadership triads of public housing resident leaders, nurse practitioner students, and public health students, the ACTIVATE program centers on mitigating uptake barriers and non-adherence to vaccination schedules as recommended by the CDC and to increase influenza, meningitis, pneumonia, VZV, and COVID-19 vaccine rates among under-resourced AA and Latino adults in South LA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Aim 3:\n\nInclusion Criteria:\n\n* identify as Latinx or African American\n* age 18 or older\n* reside in one of the six collaborating public housing area\n* Speak either English or Spanish\n* Report vaccine hesitancy\n\nExclusion Criteria:\n\n* Not a resident at one of the collaborating public housing areas\n* Does not self-identify as African American or Latinx\n* Age 17 and younger\n* Unable to speak either English or Spanish\n* Received all recommended vaccines for Influenza, Pneumonia, Meningitis, VZV, and COVID-19\n* No reporting of vaccine hesitancy'}, 'identificationModule': {'nctId': 'NCT06075732', 'briefTitle': 'ACTIVATE in Public Housing', 'organization': {'class': 'OTHER', 'fullName': 'Charles Drew University of Medicine and Science'}, 'officialTitle': 'Academic-Community Team for Improving Vaccine Acceptability and Targeted Engagement: Public Housing', 'orgStudyIdInfo': {'id': 'vaccpublichousing'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACTIVATE Leaders', 'description': 'This is a one group pretest-posttest design to increase COVID-19 vaccine uptake and completion among African American and Latinx 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 ACTIVATE triad leaders and researchers. The investigators will use the Information, Motivation, and Behavioral Skills (IMB) model and the Transtheoretical Model to implement the intervention. PRISM, a Dissemination and implementation (D\\&I) D\\&I-based model can guide the implementation of the ACTIVATE program for successfully expansion and maintenance in community settings, especially for under-resourced populations.', 'interventionNames': ['Behavioral: Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 Vaccination']}], 'interventions': [{'name': 'Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 Vaccination', 'type': 'BEHAVIORAL', 'description': 'Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce Influenza, Pneumonia, Meningitis, HZV, and COVID-19 vaccine hesitancy and increase willingness and uptake in Influenza, Pneumonia, Meningitis, HZV, and COVID-19 vaccination.', 'armGroupLabels': ['ACTIVATE Leaders']}]}, '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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles Drew University of Medicine and Science', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-02-27', 'type': 'RELEASE'}, {'date': '2025-02-27', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'Charles Drew University of Medicine and Science'}}}}