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

NCT04945655 | Completed

• 2 other identifiers: C20-762020-A02031-38
• Study Type: interventional
• Target: 30,739
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HPV Vaccine Acceptability

Keywords

Human Papillomavirus; Vaccination coverage; eHealth tools; Motivational interview; Pragmatic randomized controlled trial; Effectiveness; Implementation; Vaccination behaviors

Outcome Measures

Primary Outcomes (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

  2 months after intervention

Secondary Outcomes (9)

• 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

Study Arms (6)

Arm 1: component 1 + component 2 + component 3

EXPERIMENTAL

Adolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2) + Access to vaccination at school (component 3)

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 2

EXPERIMENTAL

Adolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2)

Other: Adolescents and parents' education and motivation at school (component 1); Other: General practitioners' training (component 2)

Arm 3: component 1 + component 3

EXPERIMENTAL

Adolescents and parents' education and motivation at school (component 1) + Access to vaccination at school (component 3)

Other: Adolescents and parents' education and motivation at school (component 1); Other: Access to vaccination at school (component 3)

Arm 4: component 1

EXPERIMENTAL

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

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

Arm 5: component 2

EXPERIMENTAL

General practitioners' training (component 2)

Other: General practitioners' training (component 2)

Arm 6: Control

NO INTERVENTION

No intervention

Interventions

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.

Arm 1: component 1 + component 2 + component 3; Arm 2: component 1 + component 2; Arm 5: component 2

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.

Arm 1: component 1 + component 2 + component 3; Arm 3: component 1 + component 3

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).

Arm 1: component 1 + component 2 + component 3; Arm 2: component 1 + component 2; Arm 3: component 1 + component 3; Arm 4: component 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adolescents (school years 9-10), and parents of adolescents (school years 7-10) attending secondary schools in the participating municipalities.

You may not qualify if:

• General practitioners' training (component 2) and "KABP-6C" survey among general practitioners (arms 1, 2 and 5)
• General practitioners' practicing in the participating municipalities.
• 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)
• 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).
• Having initiated HPV vaccination.
• No written consent from parents/caregivers for vaccination.
• Contraindication to HPV vaccination.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Secondary schools and GPs' practices of the participating municipalities

Multiple Locations, France

Location

Related Publications (6)

• 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.

  PMID: 38780943 RESULT

• 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.

  PMID: 39172389 RESULT

• 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.

  PMID: 40834467 RESULT

• 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.

  PMID: 40761362 RESULT

• 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.

  PMID: 35332045 RESULT

• 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.

  PMID: 41412015 DERIVED

Study Officials

• Nathalie THILLY, Pr

  EA 4360 APEMAC - Université de Lorraine, Nancy

  PRINCIPAL INVESTIGATOR

• Serge GILBERG, Pr

  Département de Médecine Générale - Université Paris, Paris

  STUDY DIRECTOR

• Aurélie GAUCHET, Dr

  Université Grenoble Alpes, LIP/PC2S, EA 4145, Grenoble

  STUDY DIRECTOR

• Anne-Sophie LE DUC-BANASZUK, Dr

  Centre Régional de Coordination des Dépistages des cancers-Pays de la Loire, Angers

  STUDY DIRECTOR

• Amandine GAGNEUX-BRUNON, Dr

  GIMAP, EA 3064, Université Jean Monnet, Université de Lyon, Saint-Etienne, France

  STUDY DIRECTOR

• Karine CHEVREUL, Pr

  INSERM, ECEVE UMR 1123, Paris

  STUDY DIRECTOR

• Judith MUELLER, Dr

  Unité de Recherche et d'Expertise Epidémiologie des maladies émergentes, Institut Pasteur, Paris

  STUDY DIRECTOR

• Bruno GIRAUDEAU, Pr

  INSERM CIC 1415, CHRU de Tours, Tours, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Multicentre cluster randomized controlled trial using an incomplete factorial design

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 30, 2021
• Study Start: November 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: April 30, 2023
• Last Updated: December 10, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)