NCT07266857

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 25, 2025

Last Update Submit

November 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    e-Bug educational programme

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

Secondary Outcomes (2)

  • Parental consent rate (acceptability)

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

  • Response rate (return of vaccination authorisation forms)

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

Study Arms (2)

Pilot School Using e-Bug Programme

Other: Consent for HPV vaccination

Other Middle Schools in Alpes-Maritimes Department

Other: Consent for HPV vaccination

Interventions

Consent for HPV vaccination

Other Middle Schools in Alpes-Maritimes DepartmentPilot School Using e-Bug Programme

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de NICE

Nice, Alpes Maritimes, 06000, France

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Consent Forms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Informed ConsentJurisprudenceSocial Control, FormalHealth Care Economics and OrganizationsRecordsOrganization and AdministrationHealth Services AdministrationData CollectionHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 5, 2025

Study Start

May 1, 2025

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

December 5, 2025

Record last verified: 2025-11

Locations