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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Middle School and High School Students
• Intervention / Treatment: Behavioral: HPV animation

• Study Type: Interventional
• Enrollment (Estimated): 1422
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmen Dupuis, PhD; Phone Number: +33 0469856218; Email: carmen.dupuis@lyon.unicancer.fr
• Study Contact Backup: Name: Olivia Pérol, PhD; Phone Number: +33 0478782897; Email: olivia.perol@lyon.unicancer.fr

Study Locations

• France
  • Saint-Priest, France
    • Recruiting
    • Lycée BELTRAME
    • Contact: Amélie WEBER; Phone Number: +33 0472980660; Email: Amelie.Weber@ac-lyon.fr
    • Principal Investigator: Amélie WEBER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Provision of the interactive exhibition "Taking care of yourself and preventing cancer risks" for one week (5 working days)
Experimental: Intervention : HPV animation; Provision of the interactive exhibition "Taking care of yourself and preventing cancer risks" for one week (5 working days),; Classroom presentation on HPV by a CLB-CPTS team; Distribution of prevention materials.	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 locations of possible cancers linked to HPV infection. Materials have been created to help facilitate this presentation, including five posters with the key messages to convey to students and the silhouette game (consisting of different cancer location markers).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccination	Proportion of young people who received at least one dose of HPV vaccine in each of the two groups, assessed at 6 months	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
health literacy level	assessed using the HLSAC (Health literacy for school-aged children) questionnaire. The score is simply the sum of the responses to the items, coding the responses for each item as follows: • Not at all = 1 • Rather no = 2 • Rather yes = 3 • Absolutely = 4 The score therefore ranges from 10 to 40, and three thresholds can be used to categorize health literacy levels: • HLSAC score ≤ 25: low level • HLSAC score >25 and ≤ 35: moderate level • HLSCA score > 35: high level.	inclusion (Day 0), month 6
levels of knowledge about HPV-related risks and other cancer risk factors	auto-questionnaire, multiple-choice answer	inclusion (Day 0), month 6
acceptability	quantitatively assessed using Likert scales (0-4) at the end of the intervention in the classes that received the intervention	At the end of the intervention, maximum Day 5

Collaborators and Investigators

• Sponsor: Centre Leon Berard

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: intervention; primary prevention; vaccination; HPV
• Other Study ID Numbers: PIMCOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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