Lycée BELTRAME
Saint-Priest, France
Location status: Recruiting
Recruiting
NCT Number: NCT07414719
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
11 year–17 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
HPV animation
BehavioralThis 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).
Primary outcomes
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Vaccination
Time frame: Month 6
Proportion of young people who received at least one dose of HPV vaccine in each of the two groups, assessed at 6 months
Secondary outcomes
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health literacy level
Time frame: inclusion (Day 0), month 6
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.
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levels of knowledge about HPV-related risks and other cancer risk factors
Time frame: inclusion (Day 0), month 6
auto-questionnaire, multiple-choice answer
-
acceptability
Time frame: At the end of the intervention, maximum Day 5
quantitatively assessed using Likert scales (0-4) at the end of the intervention in the classes that received the intervention
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Centre Leon Berard
Other
Registry information
Official study 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.
Acronym: PIMCOP
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Feb 17, 2026
- Registry last updated
- Feb 17, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.