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

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

Interventions

OTHER

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).

OTHER

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.

OTHER

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.

Sponsors & Collaborators

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

  lead OTHER_GOV

Principal Investigators

• 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

• 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

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-15

Primary Completion

2022-06-30

Completion

2023-04-30

Countries

• France