Papillomavirus InfectionNCT07266857
Impact of an e-Bug Educational Intervention on HPV Vaccine Uptake in Middle School Students
An observational study of Papillomavirus Infection and Papillomavirus Vaccines, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Papillomavirus Infection, Papillomavirus Vaccines, Vaccination Coveage
- What is being tested?
- Consent for HPV vaccination
- Type of treatment
- Vaccines
- How many people
- 11,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- No individual participants are enrolled. The study uses only aggregated, anonymised vaccination data routinely collected by ARS PACA
Who cannot join
- Not applicable. No individual-level inclusion or exclusion criteria are defined, as no participants are enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de NICE
Nice, Alpes Maritimes, 06000
Laure Hermet, 0492039007, hermet.l@chu-nice.fr
About this study
Official title: 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.
- Being tested
- Consent for HPV vaccination
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consent for HPV vaccinationOther
Consent for HPV vaccination
| Study group | Role | What they receive |
|---|---|---|
| Pilot School Using e-Bug Programme | Not described Receives: Other: Consent for HPV vaccination | |
| Other Middle Schools in Alpes-Maritimes Department | Not described Receives: Other: Consent for HPV vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccination uptake (1st and 2nd doses) in the pilot school compared with departmental data
e-Bug educational programme
Measured: From (start of 2023-2024 HPV vaccination campaign) to(end of 2024-2025)
Secondary outcomes (2)
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.
Measured: 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.
Measured: From (start of 2023-2024 HPV vaccination campaign) to(end of 2024-2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 May 2025
- Primary completion30 Jun 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 11,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266857
- Sponsor's protocol ID
- 25SantéMentale02
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07266857
- Acronym / sponsor ID
- 25SantéMentale02
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot School Using e-Bug Programme | – | Other: Consent for HPV vaccination |
| Other Middle Schools in Alpes-Maritimes Department | – | Other: Consent for HPV vaccination |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- No individual participants are enrolled. The study uses only aggregated, anonymised vaccination data routinely collected by ARS PACA
Key exclusion criteria (1 listed)
- Not applicable. No individual-level inclusion or exclusion criteria are defined, as no participants are enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consent for HPV vaccinationConsent for HPV vaccination | Other | Other Middle Schools in Alpes-Maritimes Department, Pilot School Using e-Bug Programme |
Primary outcome
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
2 secondary outcomes
Parental consent rate (acceptability)
Time frame: From (start of 2023-2024 HPV vaccination campaign) to(end of 2024-2025)
Response rate (return of vaccination authorisation forms)
Time frame: From (start of 2023-2024 HPV vaccination campaign) to(end of 2024-2025)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillomavirus Infection and Papillomavirus Vaccines, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laure Hermet (0492039007, hermet.l@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.