Impact of an e-Bug Educational Intervention on HPV Vaccine Uptake in Middle School Students

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

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 Overview

• Status: Recruiting
• Conditions: Papillomavirus Infection; Papillomavirus Vaccines; Vaccination Coveage
• Intervention / Treatment: Other: Consent for HPV vaccination

• Study Type: Observational
• Enrollment (Estimated): 11000

Contacts and Locations

• Study Contact: Name: Laure Hermet; Phone Number: 0492039007; Email: hermet.l@chu-nice.fr

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06000
      • Recruiting
      • Chu de Nice
      • Contact: Laure Hermet; Phone Number: 0492039007; Email: hermet.l@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pilot School Using e-Bug Programme	Other: Consent for HPV vaccination; Consent for HPV vaccination
Other Middle Schools in Alpes-Maritimes Department	Other: Consent for HPV vaccination; Consent for HPV vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental consent rate (acceptability)	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.	From (start of 2023-2024 HPV vaccination campaign) to(end of 2024-2025)
Response rate (return of vaccination authorisation forms)	Aggregated rate of returned parental authorisation forms (regardless of response: yes/no) in the pilot school compared with departmental response rates.	From (start of 2023-2024 HPV vaccination campaign) to(end of 2024-2025)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Papillomavirus Infections; Organization and Administration; Health Services Administration; Health Care Quality, Access, and Evaluation; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Economics and Organizations; Records; Jurisprudence; Social Control, Formal; Informed Consent; Consent Forms
• Other Study ID Numbers: 25SantéMentale02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No