Middle School and High School StudentsPIMCOPNCT07414719
Impact of an HPV Primary Prevention Intervention on HPV Vaccination Rates Among Adolescents in the AuRA Region.
A study testing HPV animation in people with Middle School and High School Students, run by Centre Leon Berard at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Middle School and High School Students
- What is being tested?
- HPV animation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,422 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2025to 30 Jun 2027
- Phase
- Interventional
- 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- children protected by the law
- Person specially protected by law
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
Lycée BELTRAME
Saint-Priest
Amélie WEBER, 0472980660 ext. +33, Amelie.Weber@ac-lyon.fr
Amélie WEBER
About this study
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.
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.
- Conditions
- Middle School and High School Students
- Being tested
- HPV animation
- Keywords
- HPV, primary prevention, vaccination, intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV animationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Provision of the interactive exhibition "Taking care of yourself and preventing cancer risks" for one week (5 working days) |
| Intervention : HPV animation | Experimental | * 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. Receives: Behavioral: HPV animation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination
Proportion of young people who received at least one dose of HPV vaccine in each of the two groups, assessed at 6 months
Measured: Month 6
Secondary outcomes (3)
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.
Measured: inclusion (Day 0), month 6
levels of knowledge about HPV-related risks and other cancer risk factors
auto-questionnaire, multiple-choice answer
Measured: 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
Measured: At the end of the intervention, maximum Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start16 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle School and High School StudentsStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414719
- Sponsor's protocol ID
- PIMCOP
- Acronym
- PIMCOP
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07414719
- Acronym / sponsor ID
- PIMCOP / PIMCOP
- Conditions
- Middle School and High School Students
- Keywords
- HPV, primary prevention, vaccination, intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,422 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Feb 2026 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Provision of the interactive exhibition "Taking care of yourself and preventing cancer risks" for one week (5 working days) |
| Intervention : HPV animation | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (2 listed)
- children protected by the law
- Person specially protected by law
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 |
|---|---|---|
| HPV animationThis 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). | Behavioural | Intervention : HPV animation |
Primary outcome
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
3 secondary outcomes
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
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 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Middle School and High School Students
Recruiting
A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students
Substance Use, Harm Reduction
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?
A study testing HPV animation in people with Middle School and High School Students, run by Centre Leon Berard 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 11 inclusion and 2 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 17 Feb 2026. 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 Carmen DUPUIS, PhD (0469856218 ext. +33, carmen.dupuis@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination (time frame: Month 6). 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 17 Feb 2026.