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Recruiting NCT07414719

Impact of an HPV Primary Prevention Intervention on HPV Vaccination Rates Among Adolescents in the AuRA Region.

No phase Interventional Middle School and High School Students

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HPV animation.
Who it may be relevant to
Registry conditions: Middle School and High School Students. Basic parameters: 11 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective, Randomized, Cluster-controlled, Multicenter Study to Evaluate the Impact of an HPV Primary Prevention Intervention on HPV Vaccination Rates Among Adolescents in the AuRA Region.

Overview

Human papillomaviruses (HPV) are very common contagious viruses: approximately 70% of men and women will be infected during their lifetime. Vaccination, recommended since 2007 for girls and since 2021 for all young people aged 11 to 14 (with catch-up vaccination possible up to age 26), remains insufficiently followed. Today, only 40.7% of adolescents are vaccinated in France, and the Auvergne Rhône Alpes region remains below the targets (47.5% for girls and 12.3% for boys). This is still far from the national target of 80% vaccination coverage by 2030, while 6,400 new cases of HPV-related cancers are reported each year. The PIMCOP regional study aims to assess the impact of a primary prevention intervention, co-developed with stakeholders and implemented in middle and high schools, on the HPV vaccination rate at 6 months among 11-17 year olds.

Interventions

  • Behavioral HPV animation
    This presentation will enable young people to gather key information about HPV: - What is it? - How is it transmitted? - Who is affected? - What are the possible consequences? - How can you protect yourself? To this end, it was decided to hold a 1.5-hour presentation for 9th grade classes in middle school and 12th grade classes in high school. This presentation consists of a discussion with the students about the five key pieces of information mentioned above, followed by a game to find the loca

Primary outcome measures

  • Vaccination [Time frame: Month 6]
Secondary outcome measures (3)
  • health literacy level [Time frame: inclusion (Day 0), month 6]
  • levels of knowledge about HPV-related risks and other cancer risk factors [Time frame: inclusion (Day 0), month 6]
  • acceptability [Time frame: At the end of the intervention, maximum Day 5]

Eligibility criteria

Inclusion Criteria for children :

  • Girl or boy, student at a public school participating in the study
  • Aged 11 to 17
  • Having received an information sheet about the study and having signed a declaration of non-objection
  • Whose parents have also received an information sheet and have not expressed their non-objection
  • Able to read, write, and understand French
  • Affiliated with the SS or equivalent

Exclusion Criteria for children:

  • children protected by the law

Inclusion Criteria for teachers :

  • Male or female, teacher at a public school participating in the study and supervising a participating class
  • Aged 18 or over
  • Having received an information sheet about the study and not having expressed their opposition
  • Able to read, write, and understand French
  • Affiliated with the SS or equivalent

Exclusion Criteria for teachers :

\- Person specially protected by law

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • Lycée BELTRAME — Saint-Priest

Identifiers

NCT: NCT07414719 · PIMCOP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗