Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-27 @ 6:47 AM
Study NCT ID:
NCT05148559
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2021-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Adolescent Vaccine Reminder Notices Sent Via Preferred Method of Communication on HPV Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-20', 'size': 971290, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-02T15:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5451}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients that received 1 dose of HPV vaccine during follow-up based on electronic health data', 'timeFrame': '90 days', 'description': 'Receipt of 1 dose of HPV vaccine within 90 days of receipt of reminder (yes/no) will be assessed using vaccination data available from the Marshfield Clinic Health System electronic health record, which includes vaccinations administered outside of MCHS through data exchanges with the Wisconsin Immunization Registry. Specifically patients will be classified as having received 1 dose of HPV vaccine if they have record of receipt of HPV vaccine with a vaccination date during the 90-day follow-up period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Papillomavirus Vaccines']}, 'descriptionModule': {'briefSummary': "Vaccine uptake in the United States is lower in rural areas, especially for HPV vaccine. Reminder/recall has been identified as an effective strategy to increase vaccination rates. This study will assess the impact by rurality of vaccine reminder notices sent via the parent's preferred method of communication on HPV vaccination among 12 year-old patients in a regional healthcare system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Marshfield Clinic Health System patient aged 12 years with at least one preventive visit or two evaluation \\& management visits with a Marshfield Clinic Health System provider in the last 36 months\n* Due for at least one adolescent vaccine (HPV, MenACWY, Tdap)\n\nExclusion Criteria:\n\n* Primary care provider is not affiliated with Marshfield Clinic Health System\n* Opted out of Marshfield Clinic Health System vaccine reminder notifications\n* Missing or invalid contact information\n* Deceased'}, 'identificationModule': {'nctId': 'NCT05148559', 'briefTitle': 'Impact of Adolescent Vaccine Reminder Notices Sent Via Preferred Method of Communication on HPV Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Marshfield Clinic Research Foundation'}, 'officialTitle': 'Understanding and Addressing the Disparity in Vaccination Coverage Among U.S. Adolescents Living in Rural Versus Urban Areas', 'orgStudyIdInfo': {'id': 'MCL10517'}, 'secondaryIdInfos': [{'id': 'U01IP001093', 'link': 'https://reporter.nih.gov/quickSearch/U01IP001093', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Reminder', 'interventionNames': ['Behavioral: Reminder Sent Via Preferred Method of Communication']}, {'type': 'OTHER', 'label': 'Standard of Care', 'interventionNames': ['Behavioral: Reminder Sent Via Mailed Letter']}], 'interventions': [{'name': 'Reminder Sent Via Preferred Method of Communication', 'type': 'BEHAVIORAL', 'description': 'Parents of 12 year-old patients due for ≥1 adolescent vaccine will receive a vaccine reminder notice every other month via their preferred method of communication (text message, email, mailed letter) until the adolescent receives all recommended vaccines, opts out of reminders, or turns 13.', 'armGroupLabels': ['Enhanced Reminder']}, {'name': 'Reminder Sent Via Mailed Letter', 'type': 'BEHAVIORAL', 'description': 'Parents of 12 year-old patients due for ≥1 adolescent vaccine will receive a mailed vaccine reminder letter every other month until the adolescent receives all recommended vaccines, opts out of reminders, or turns 13.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinic Health System', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}], 'overallOfficials': [{'name': 'Huong McLean, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marshfield Clinic Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huong Nguyen, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Research Scientist', 'investigatorFullName': 'Huong Nguyen, PhD', 'investigatorAffiliation': 'Marshfield Clinic Research Foundation'}}}}