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

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07414719
Acronym
PIMCOP
Enrollment
1422
Registered
2026-02-17
Start date
2025-12-16
Completion date
2027-06-30
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Middle School and High School Students

Keywords

HPV, primary prevention, vaccination, intervention

Brief summary

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

BEHAVIORALHPV 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).

Sponsors

Centre Leon Berard
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
VaccinationMonth 6Proportion of young people who received at least one dose of HPV vaccine in each of the two groups, assessed at 6 months

Secondary

MeasureTime frameDescription
health literacy levelinclusion (Day 0), month 6assessed 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.
levels of knowledge about HPV-related risks and other cancer risk factorsinclusion (Day 0), month 6auto-questionnaire, multiple-choice answer
acceptabilityAt the end of the intervention, maximum Day 5quantitatively assessed using Likert scales (0-4) at the end of the intervention in the classes that received the intervention

Countries

France

Contacts

CONTACTCarmen DUPUIS, PhD
carmen.dupuis@lyon.unicancer.fr0469856218
CONTACTOlivia PEROL, PhD
olivia.perol@lyon.unicancer.fr0478782897

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026