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HPV Vaccine AcceptabilityPrevHPVNCT04945655

Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability

A study testing Adolescents and parents' education and motivation at school (component 1), General practitioners' training (component 2) and Access to vaccination at school (component 3) in people with HPV Vaccine Acceptability, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims at evaluating the effectiveness, efficiency and implementation of a multicomponent intervention (components being applied in combination or alone) on the acceptability of HPV vaccine among French adolescents (11-14 years old) through a cluster randomized controlled trial. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
HPV Vaccine Acceptability
What is being tested?
Adolescents and parents' education and motivation at school (component 1), General practitioners' training (component 2) and Access to vaccination at school (component 3)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30,739 participants
Where
1 siteFrance
Study dates
15 Nov 2021to 30 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Adolescents (school years 9-10), and parents of adolescents (school years 7-10) attending secondary schools in the participating municipalities.
  • General practitioners' practicing in the participating municipalities.
  • Adolescents (school years 7-10) attending secondary schools in the participating municipalities, aged 11-14 years (with a possible catch-up for those aged 15-19 years according to the French recommendations).

Who cannot join

  • /
  • General practitioners' training (component 2) and "KABP-6C" survey among general practitioners (arms 1, 2 and 5)
  • Exclusive particular type of practice.
  • Planning to retire or move their practice within the study period.
  • No internet access.
  • Access to vaccination at school (component 3 -- arms 1 and 3)
Show all 9Show fewer
  • Having initiated HPV vaccination.
  • No written consent from parents/caregivers for vaccination.
  • Contraindication to HPV vaccination.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Secondary schools and GPs' practices of the participating municipalities

    Multiple Locations

Other trials in France

About this study

Official title: Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability Among French Adolescents: a Cluster Randomized Controlled Trial

This study aims at evaluating the effectiveness, efficiency and implementation of a multicomponent intervention (components being applied in combination or alone) on the acceptability of HPV vaccine among French adolescents (11-14 years old) through a cluster randomized controlled trial. The primary outcome to measure acceptability is vaccine coverage. The three components are: adolescents and parents' education and motivation at school (component 1); general practitioners' training (component 2); and access to vaccination at school (component 3). Ninety municipalities are included and randomized into six groups of 15 municipalities, according an incomplete factorial plan.

Being tested
Adolescents and parents' education and motivation at school (component 1), General practitioners' training (component 2), Access to vaccination at school (component 3)
Keywords
Human Papillomavirus, Vaccination coverage, eHealth tools, Motivational interview, Pragmatic randomized controlled trial, Effectiveness, Implementation, Vaccination behaviors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adolescents and parents' education and motivation at school (component 1)Other

    The component 1 includes first an information group session (duration: 1h30) on HPV infection and vaccination for parents. This session starts with a webconference delivered by two medical experts on HPV, using a standardized presentation. Then, a discussion is open for parents' questions and/or comments.

    Second, adolescents participate during the school time to two educational group sessions on HPV infections and vaccination, using a pedagogy based on active learning. These sessions (duration: 2h each) are delivered by the school staff (e.g., nurse, teacher in life sciences) using an educational package comprising: a guide that describes activities that should be implemented during each session; one video and a fact sheet developed by health students; a serious video game that promotes HPV vaccination and accessible on an internet website. Before the sessions, the school staff is encouraged to attend an e-learning training course (duration: 1 hour).

  • General practitioners' training (component 2)Other

    The component 2 consists of an individual e-learning training session for general practitioners (GPs) that is accessible on computer and smartphone. Lasting 3 hours, GPs are able to access to the training whenever they want and then to progress at their own pace. The training includes three main parts: up-dated information on HPV infection and vaccination; an introduction to the use of motivational interviewing techniques in the field of vaccination; and a presentation of the decision aid tool developed as part of the intervention and explanation of how to use it during consultations. GPs may ask questions to the consortium team by using a dedicated chat.

  • Access to vaccination at school (component 3)Other

    The component 3 aims at enhancing access to HPV vaccination for adolescents by offering them the first free-of-charge injection at school, without any medical prescription. For each concerned school, we organise a vaccination day inside the school premises where health professionals (one physician and one nurse) from the local vaccination centre initiate HPV vaccination with Gardasil-9® (in accordance with the French recommendations) for all eligible adolescents.

Study groups in NCT04945655
Study groupRoleWhat they receive
Arm 1: component 1 + component 2 + component 3ExperimentalAdolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2) + Access to vaccination at school (component 3)
Receives: Other: Adolescents and parents' education and motivation at school (component 1); Other: General practitioners' training (component 2); Other: Access to vaccination at school (component 3)
Arm 2: component 1 + component 2ExperimentalAdolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2)
Receives: Other: Adolescents and parents' education and motivation at school (component 1); Other: General practitioners' training (component 2)
Arm 3: component 1 + component 3ExperimentalAdolescents and parents' education and motivation at school (component 1) + Access to vaccination at school (component 3)
Receives: Other: Adolescents and parents' education and motivation at school (component 1); Other: Access to vaccination at school (component 3)
Arm 4: component 1ExperimentalAdolescents and parents' education and motivation at school (component 1)
Receives: Other: Adolescents and parents' education and motivation at school (component 1)
Arm 5: component 2ExperimentalGeneral practitioners' training (component 2)
Receives: Other: General practitioners' training (component 2)
Arm 6: ControlNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HPV vaccine coverage (≥ 1 dose)

    Percentage of adolescents aged 11-14 years, living in the municipality, who have received at least one dose of HPV vaccine

    Measured: 2 months after intervention

Secondary outcomes (9)

  1. HPV vaccine coverage (≥ 1 dose)

    Percentage of adolescents aged 11-14 years, living in the municipality, who have received at least one dose of HPV vaccine

    Measured: 6 months and 12 months after intervention

  2. HPV vaccine coverage (2 doses)

    Percentage of adolescents aged 11-14 years, living in the municipality, who have received two doses of HPV vaccine

    Measured: 2 months, 6 months and 12 months after intervention

  3. HPV vaccination intention

    Percentage of each group of participants (adolescents, parents and general practitioners) who have the intention to initiate/have their child vaccinated/recommend HPV vaccination

    Measured: Before intervention and 2 months after intervention

  4. Knowledge, attitude, beliefs and practices towards HPV vaccination and psychological determinants of vaccination intention ("KABP-6C")

    Each group participants' (adolescents, parents and general practitioners) knowledge and attitude towards HPV vaccination will be assessed for each of the " 6-C " components (Confidence, Complacency, Constraints, Calculation, Collective responsibility and social Conformism). Following results from otherwise onging research on psychological antecedents of vaccination, a 7 th C has been identified, refering to Confidence in the system (including reactance). The 6C thus has been extended to a 7C scale.

    In addition to analysis of individual items, a score of knowledge (from 0 - poor knowledge -- to 12 -- good knowledge) and a score of attitude (from 0 - unfavourable attitude -- to 24 - very favourable attitude) will then be calculated. Practices towards HPV vaccination (self-declared vaccination status / recommendation to patients) will be assessed using closed questions. Data will be collected using ad hoc self-administered online KABP-7C questionnaires.

    Measured: Before intervention and 2 months after intervention

  5. Incremental Cost-Effectiveness Ratio

    Incremental Cost-Effectiveness Ratio

    Measured: 2 months after intervention

  6. Intervention components' dose and fidelity

    Number of different activities really performed for each component / number of activities planned for each component according to the protocol. Data come from regular activity reports collected on a standardised form during components' implementation.

    Measured: Intervention components' implementation period

  7. Reached populations

    Percentage of target individuals who benefit from (or participate in) activities of each component (assessment of the acceptability of each component)

    Measured: Intervention components' implementation period

  8. Intervention components' adaptation

    Number of activities performed which have been modified to adapt them to the local context / total number of activities performed. A description of the adaptations performed will be provided. Data come from regular activity reports collected on a standardised form during components' implementation.

    Measured: Intervention components' implementation period

  9. Satisfaction of target populations about the activities / tools, assessed by a 4-point Likert scale

    Percentage of target individuals (adolescents, parents and general practitioners) who declare to be satisfied with each activity / tool (e.g., satisfaction of adolescents and school staff about the vaccination day organized inside the school premises, satisfaction of general practitioners about the e-learning training session). Satisfaction will be collected using self-administered (paper or online) questionnaires.

    Measured: End of the intervention components' implementation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start15 Nov 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Apr 2023

Resources

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
Factorial
Model description
Multicentre cluster randomized controlled trial using an incomplete factorial design
Masking
None (open label)
Enrolment
30,739 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04945655
Sponsor's protocol ID
C20-76
Other IDs
2020-A02031-38
Acronym
PrevHPV
Status last verified
Jul 2023
First submitted
7 Jun 2021
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thilly N, Michel M, Simon M, Bocquier A, Gagneux-Brunon A, Gauchet A, Gilberg S, Le Duc-Banaszuk AS, Bruel S, Mueller JE, Giraudeau B, Chevreul K; PrevHPV Study Group. Effectiveness of a School- and Primary Care-Based HPV Vaccination Intervention: The PrevHPV Cluster Randomized Trial. JAMA Netw Open. 2024 May 1;7(5):e2411938. doi: 10.1001/jamanetworkopen.2024.11938.

    PubMed 38780943

  • Oudin Doglioni D, Gauchet A, Gagneux-Brunon A, Bruel S, Banaszuk AS, Thilly N, Sicsic J, Raude J, Mueller JE; PrevHPV Consortium. Shared human papillomavirus vaccine readiness within families: A psychometric analysis of parent-adolescent dyads in France. Health Psychol. 2024 Dec;43(12):893-903. doi: 10.1037/hea0001387. Epub 2024 Aug 22.

    PubMed 39172389

  • Bocquier A, Simon M, Michel M, Bonnay S, Adam I, Gilberg S, Bruel S, Gauchet A, LeDuc-Banaszuk AS, Gagneux-Brunon A, Mueller JE, Giraudeau B, Thilly N; PrevHPV Study Group. Implementation evaluation of a school- and primary care-based multicomponent intervention to improve HPV vaccine coverage: Results from the PrevHPV randomized controlled trial. J Infect Public Health. 2025 Nov;18(11):102931. doi: 10.1016/j.jiph.2025.102931. Epub 2025 Aug 15.

    PubMed 40834467

  • Dussault J, Gagneux-Brunon A, Le Duc-Banaszuk AS, Bruel S, Michel M, Gauchet A, Oudin Doglioni D, Sicsic J, Raude J, Barret AS, Thilly N, Mueller JE; PrevHPV Group. Effect of a multicomponent HPV intervention on self-reported HPV vaccine uptake and intention among French adolescents and parents: results from the national, cluster-randomised PrevHPV trial. BMJ Public Health. 2025 Aug 3;3(2):e001007. doi: 10.1136/bmjph-2024-001007. eCollection 2025.

    PubMed 40761362

  • Bocquier A, Michel M, Giraudeau B, Bonnay S, Gagneux-Brunon A, Gauchet A, Gilberg S, Le Duc-Banaszuk AS, Mueller JE, Chevreul K, Thilly N; PrevHPV Study group. Impact of a school-based and primary care-based multicomponent intervention on HPV vaccination coverage among French adolescents: a cluster randomised controlled trial protocol (the PrevHPV study). BMJ Open. 2022 Mar 24;12(3):e057943. doi: 10.1136/bmjopen-2021-057943.

    PubMed 35332045

  • Bocquier A, Michel M, Mueller JE, Simon M, Gagneux-Brunon A, Gauchet A, Gilberg S, Le Duc-Banaszuk AS, Bruel S, Giraudeau B, Thilly N; PrevHPV Study Group. One-year impact on HPV vaccination coverage of a school- and primary care-based intervention: the PrevHPV cluster randomised trial. Sci Rep. 2026 Jun 22. doi: 10.1038/s41598-026-48222-x. Online ahead of print.

    PubMed 42324267

  • Bocquier A, Cadoret S, Fall E, Bonnay S, LeDuc-Banaszuk AS, Branchereau M, Gauchet A, Bruel S, Gagneux-Brunon A, Giraudeau B, Michel M, Mueller JE, Lefevre B, Thilly N; PrevHPV Study Group. Process evaluation of a school-based vaccination intervention to improve HPV vaccine coverage: A mixed-method study embedded in the French PrevHPV cluster randomized controlled trial. Vaccine. 2026 Feb 6;72:128122. doi: 10.1016/j.vaccine.2025.128122. Epub 2025 Dec 17.

    PubMed 41412015

Questions about this trial

What is this clinical trial studying?

A study testing Adolescents and parents' education and motivation at school (component 1), General practitioners' training (component 2) and Access to vaccination at school (component 3) in people with HPV Vaccine Acceptability, run by Institut National de la Santé Et de la Recherche Médicale, France 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 10 Dec 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HPV vaccine coverage (≥ 1 dose) (time frame: 2 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04945655, which also lists 7 linked publications.

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 10 Dec 2025.

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