Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
Study NCT ID:
NCT07266857
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of an e-Bug Educational Intervention on HPV Vaccine Uptake in Middle School Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D032962', 'term': 'Consent Forms'}], 'ancestors': [{'id': 'D007258', 'term': 'Informed Consent'}, {'id': 'D007603', 'term': 'Jurisprudence'}, {'id': 'D012926', 'term': 'Social Control, Formal'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2025-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPV vaccination uptake (1st and 2nd doses) in the pilot school compared with departmental data', 'timeFrame': 'From (start of 2023-2024 HPV vaccination campaign) to(end of 2024-2025)', 'description': 'e-Bug educational programme'}], 'secondaryOutcomes': [{'measure': 'Parental consent rate (acceptability)', 'timeFrame': 'From (start of 2023-2024 HPV vaccination campaign) to(end of 2024-2025)', 'description': 'Aggregated proportion of parents providing positive consent for HPV vaccination in the pilot school, compared with aggregated departmental consent rates collected by ARS PACA during the 2023-2024 and 2024-2025 school-based campaigns.'}, {'measure': 'Response rate (return of vaccination authorisation forms)', 'timeFrame': 'From (start of 2023-2024 HPV vaccination campaign) to(end of 2024-2025)', 'description': 'Aggregated rate of returned parental authorisation forms (regardless of response: yes/no) in the pilot school compared with departmental response rates.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Papillomavirus Infection', 'Papillomavirus Vaccines', 'Vaccination Coveage']}, 'descriptionModule': {'briefSummary': 'This study is a non-interventional observational pilot analysis assessing the possible impact of an educational programme (e-Bug) on parental consent and HPV vaccination uptake during the 2023-2024 and 2024-2025 national school-based HPV vaccination campaigns in France. The study focuses on one middle school in the Alpes-Maritimes department where teachers and the school nurse had been previously trained on HPV and used e-Bug educational resources in class as part of routine health education. No research-related intervention was conducted, and the educational programme was not introduced or modified for the purpose of the study. Only aggregated and anonymised vaccination data were used. These data were routinely collected by the Regional Health Agency (ARS PACA) as part of the national vaccination programme and transmitted for analysis. Aggregated data from the pilot school were compared with departmental-level outcomes to describe whether an upstream educational approach may be associated with improved parental acceptance and higher HPV vaccination coverage. This study aims to contribute to the understanding of educational determinants of vaccine uptake in a real-life school setting without involving any participant recruitment or individual data collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Aggregated data from 5th-grade students enrolled in one pilot middle school using the e-Bug programme, compared with aggregated data from all other middle schools in the Alpes-Maritimes department. No individual-level data were accessed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No individual participants are enrolled. The study uses only aggregated, anonymised vaccination data routinely collected by ARS PACA\n\nExclusion Criteria:\n\n* Not applicable. No individual-level inclusion or exclusion criteria are defined, as no participants are enrolled.'}, 'identificationModule': {'nctId': 'NCT07266857', 'briefTitle': 'Impact of an e-Bug Educational Intervention on HPV Vaccine Uptake in Middle School Students', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Pilot Observational Comparative Study Evaluating the Impact of the e-Bug Educational Programme on Parental Consent and HPV Vaccination Coverage During the National School-Based Vaccination Campaign in a Middle School in the Alpes-Maritimes', 'orgStudyIdInfo': {'id': '25SantéMentale02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pilot School Using e-Bug Programme', 'interventionNames': ['Other: Consent for HPV vaccination']}, {'label': 'Other Middle Schools in Alpes-Maritimes Department', 'interventionNames': ['Other: Consent for HPV vaccination']}], 'interventions': [{'name': 'Consent for HPV vaccination', 'type': 'OTHER', 'description': 'Consent for HPV vaccination', 'armGroupLabels': ['Other Middle Schools in Alpes-Maritimes Department', 'Pilot School Using e-Bug Programme']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'state': 'Alpes Maritimes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laure Hermet', 'role': 'CONTACT', 'email': 'hermet.l@chu-nice.fr', 'phone': '0492039007'}], 'facility': 'CHU de NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Laure Hermet', 'role': 'CONTACT', 'email': 'hermet.l@chu-nice.fr', 'phone': '0492039007'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}