Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability
NCT ID: NCT04945655
Last Updated: 2025-12-10
Study Results
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Basic Information
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COMPLETED
NA
30739 participants
INTERVENTIONAL
2021-11-15
2023-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Arm 1: component 1 + component 2 + component 3
Adolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2) + Access to vaccination at school (component 3)
Adolescents and parents' education and motivation at school (component 1)
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)
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)
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.
Arm 2: component 1 + component 2
Adolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2)
Adolescents and parents' education and motivation at school (component 1)
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)
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.
Arm 3: component 1 + component 3
Adolescents and parents' education and motivation at school (component 1) + Access to vaccination at school (component 3)
Adolescents and parents' education and motivation at school (component 1)
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).
Access to vaccination at school (component 3)
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.
Arm 4: component 1
Adolescents and parents' education and motivation at school (component 1)
Adolescents and parents' education and motivation at school (component 1)
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).
Arm 5: component 2
General practitioners' training (component 2)
General practitioners' training (component 2)
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.
Arm 6: Control
No intervention
No interventions assigned to this group
Interventions
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Adolescents and parents' education and motivation at school (component 1)
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)
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)
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
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)
* Having initiated HPV vaccination.
* No written consent from parents/caregivers for vaccination.
* Contraindication to HPV vaccination.
ALL
Yes
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Nathalie THILLY, Pr
Role: PRINCIPAL_INVESTIGATOR
EA 4360 APEMAC - Université de Lorraine, Nancy
Serge GILBERG, Pr
Role: STUDY_DIRECTOR
Département de Médecine Générale - Université Paris, Paris
Aurélie GAUCHET, Dr
Role: STUDY_DIRECTOR
Université Grenoble Alpes, LIP/PC2S, EA 4145, Grenoble
Anne-Sophie LE DUC-BANASZUK, Dr
Role: STUDY_DIRECTOR
Centre Régional de Coordination des Dépistages des cancers-Pays de la Loire, Angers
Amandine GAGNEUX-BRUNON, Dr
Role: STUDY_DIRECTOR
GIMAP, EA 3064, Université Jean Monnet, Université de Lyon, Saint-Etienne, France
Karine CHEVREUL, Pr
Role: STUDY_DIRECTOR
INSERM, ECEVE UMR 1123, Paris
Judith MUELLER, Dr
Role: STUDY_DIRECTOR
Unité de Recherche et d'Expertise Epidémiologie des maladies émergentes, Institut Pasteur, Paris
Bruno GIRAUDEAU, Pr
Role: STUDY_DIRECTOR
INSERM CIC 1415, CHRU de Tours, Tours, France
Locations
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Secondary schools and GPs' practices of the participating municipalities
Multiple Locations, , France
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2020-A02031-38
Identifier Type: REGISTRY
Identifier Source: secondary_id
C20-76
Identifier Type: -
Identifier Source: org_study_id
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