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Clinical Trials/NCT07266857
NCT07266857
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country11,000 target enrollmentStarted: May 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
11,000
Locations
1
Primary Endpoint
HPV vaccination uptake (1st and 2nd doses) in the pilot school compared with departmental data

Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • No individual participants are enrolled. The study uses only aggregated, anonymised vaccination data routinely collected by ARS PACA

Exclusion Criteria

  • Not applicable. No individual-level inclusion or exclusion criteria are defined, as no participants are enrolled.

Outcomes

Primary Outcomes

HPV vaccination uptake (1st and 2nd doses) in the pilot school compared with departmental data

Time Frame: From (start of 2023-2024 HPV vaccination campaign) to(end of 2024-2025)

e-Bug educational programme

Secondary Outcomes

  • Response rate (return of vaccination authorisation forms)(From (start of 2023-2024 HPV vaccination campaign) to(end of 2024-2025))
  • Parental consent rate (acceptability)(From (start of 2023-2024 HPV vaccination campaign) to(end of 2024-2025))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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