Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-09 @ 6:16 PM
Study NCT ID:
NCT03955757
Status:
UNKNOWN
Last Update Posted:
2022-08-16
First Post:
2019-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Boot Camp Translation to Address Rural Disparities in Adolescent Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study team data analyst will be provided with blinded data.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-12', 'studyFirstSubmitDate': '2019-05-13', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Receipt of influenza vaccine', 'timeFrame': 'Up to 24 months', 'description': 'Percent of 11-17 year olds who receive the influenza vaccine between Sept 2020 and May 2021'}], 'primaryOutcomes': [{'measure': 'Initiation of HPV vaccination series, 11-12 year olds', 'timeFrame': 'Up to 24 months', 'description': 'Percent of 11-12 year olds who have received \\>=1 dose of the HPV vaccine by May 31,2021'}], 'secondaryOutcomes': [{'measure': 'Completion of HPV vaccination series, 11-12 year olds', 'timeFrame': 'Up to 24 months', 'description': 'Percent of 11-12 year olds with \\>=2 doses of the HPV vaccine by May 31,2021'}, {'measure': 'Initiation of HPV vaccination series, 13-17 year olds', 'timeFrame': 'Up to 24 months', 'description': 'Percent of 13-17 year olds who have received \\>=1 dose of the HPV vaccine by May 31,2021'}, {'measure': 'Completion of HPV vaccination series, 13-17 year olds', 'timeFrame': 'Up to 24 months', 'description': 'Percent of 13-17 year olds who have completed the HPV vaccine series (2 or 3 doses, depending on age of initiation) by May 31,2021'}, {'measure': 'Receipt of Tdap vaccine, 11-12 year olds', 'timeFrame': 'Up to 24 months', 'description': 'Percent of 11-12 year olds who have received Tdap vaccine by May 31,2021'}, {'measure': 'Receipt of Tdap vaccine, 13-17 year olds', 'timeFrame': 'Up to 24 months', 'description': 'Percent of 13-17 year olds who have received Tdap vaccine by May 31,2021'}, {'measure': 'Receipt of MCV vaccine, 11-12 year olds', 'timeFrame': 'Up to 24 months', 'description': 'Percent of 11-12 year olds who have received \\>=1 dose of MCV vaccine by May 31,2021'}, {'measure': 'Receipt of MCV vaccine, 13-17 year olds', 'timeFrame': 'Up to 24 months', 'description': 'Percent of 13-17 year olds who have received \\>=1 dose of MCV vaccine by May 31,2021'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunization', 'Boot Camp Translation', 'Adolescent'], 'conditions': ['Primary Prevention']}, 'referencesModule': {'references': [{'pmid': '38253469', 'type': 'DERIVED', 'citation': "Cataldi JR, Suresh K, Brewer SE, Perreira C, Nederveld A, Skenadore A, Furniss A, Williams C, Severson R, Dempsey AF, O'Leary ST. Boot Camp Translation using Community-Engaged messaging for adolescent Vaccination: A Cluster-Randomized trial. Vaccine. 2024 Feb 15;42(5):1078-1086. doi: 10.1016/j.vaccine.2024.01.042. Epub 2024 Jan 21."}]}, 'descriptionModule': {'briefSummary': 'The overall goal of this project is to implement the Boot Camp Translation process to develop a replicable approach for increasing adolescent vaccine uptake that can be adaptable and feasible to use in rural settings more broadly.', 'detailedDescription': 'Boot Camp Translation (BCT) is a process to identify strategies that help communities improve health. It is a 6-month, facilitated, iterative community engagement process that brings together relevant stakeholders to develop and implement locally meaningful messages, materials, and strategies for health topics of interest.\n\nThis is a novel community engagement process that has a proven ability to result in meaningful and impactful strategies to improve compliance with recommended health behaviors in rural communities. The investigators will expand this work by testing BCT on its ability to improve vaccination with all recommend adolescent vaccines (Tdap, MenACWY, HPV, Flu).\n\nThe investigators will conduct a randomized, controlled trial in which 4 rural communities in Western Colorado will undergo BCT to develop and implement strategies to increase adolescent vaccination. Vaccination rates will be compared to 4 control communities that do not undergo BCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must live in one of the designated Colorado communities\n\nExclusion Criteria:\n\n* Does not live in one of the designated Colorado communities'}, 'identificationModule': {'nctId': 'NCT03955757', 'acronym': 'RADVax', 'briefTitle': 'Using Boot Camp Translation to Address Rural Disparities in Adolescent Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Using Boot Camp Translation to Address Rural Disparities in Adolescent Vaccination', 'orgStudyIdInfo': {'id': '18-1588'}, 'secondaryIdInfos': [{'id': 'U01IP001091', 'link': 'https://reporter.nih.gov/quickSearch/U01IP001091', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Boot Camp Translation', 'description': 'Intervention communities will undergo the Boot Camp Translation process.', 'interventionNames': ['Behavioral: Boot Camp Translation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control communities will behave as usual', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Boot Camp Translation', 'type': 'BEHAVIORAL', 'description': 'Communities in the intervention arm will participate in the Boot Camp translation process, where stakeholders will come together to develop and implement locally relevant materials to promote adolescent vaccination.', 'armGroupLabels': ['Boot Camp Translation']}, {'name': 'Control', 'type': 'OTHER', 'description': 'No intervention. Communities will continue to behave as usual.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': "Sean T O'Leary, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Amanda Dempsey, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}