NCT04945655|Completed
Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability
PrevHPV
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PrevHPV
Sponsor study identifier
Secondary identifiers
REGISTRY · ID-RCB
interventional
30,739
1 country
1
Study Start
November 15, 2021
Actual (reported)Primary Completion
June 30, 2022
Actual (reported)Study Completion
April 30, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 7, 2021
Actual (reported)June 30, 2021
Actual (reported)November 15, 2021
Actual (reported)June 30, 2022
Actual (reported)April 30, 2023
Actual (reported)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
2 months after intervention
HPV vaccine coverage (≥ 1 dose)
6 months and 12 months after intervention
HPV vaccine coverage (2 doses)
2 months, 6 months and 12 months after intervention
HPV vaccination intention
Before intervention and 2 months after intervention
Knowledge, attitude, beliefs and practices towards HPV vaccination and psychological determinants of vaccination intention ("KABP-6C")
Before intervention and 2 months after intervention
Incremental Cost-Effectiveness Ratio
2 months after intervention
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) + General practitioners' training (component 2)
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).
Secondary schools and GPs' practices of the participating municipalities
Multiple Locations, France
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.
Nathalie THILLY, Pr
EA 4360 APEMAC - Université de Lorraine, Nancy
Serge GILBERG, Pr
Département de Médecine Générale - Université Paris, Paris
Aurélie GAUCHET, Dr
Université Grenoble Alpes, LIP/PC2S, EA 4145, Grenoble
Anne-Sophie LE DUC-BANASZUK, Dr
Centre Régional de Coordination des Dépistages des cancers-Pays de la Loire, Angers
30,739 participants (actual enrollment reported by the registry).
First Submitted
June 7, 2021
First Posted
June 30, 2021
Study Start
November 15, 2021
Actual (reported)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)
General practitioners' training (component 2)
No intervention
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
Amandine GAGNEUX-BRUNON, Dr
GIMAP, EA 3064, Université Jean Monnet, Université de Lyon, Saint-Etienne, France
Karine CHEVREUL, Pr
INSERM, ECEVE UMR 1123, Paris
Judith MUELLER, Dr
Unité de Recherche et d'Expertise Epidémiologie des maladies émergentes, Institut Pasteur, Paris
Bruno GIRAUDEAU, Pr
INSERM CIC 1415, CHRU de Tours, Tours, France
Primary Completion
June 30, 2022
Actual (reported)Study Completion
April 30, 2023
Actual (reported)Last Updated
December 10, 2025
Record last verified: 2023-07
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