Clinical trial NCT04945655: Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability
Official title: Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability Among French Adolescents: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Vaccine Acceptability
Keywords: Human Papillomavirus
Vaccination coverage
eHealth tools
Motivational interview
Pragmatic randomized controlled trial
Effectiveness
Implementation
Vaccination behaviors
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2021-06-30
Enrollment: 30739
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Multicentre cluster randomized controlled trial using an incomplete factorial design
Primary purpose: PREVENTION

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.


Eligibility criteria: Adolescents and parents' education and motivation at school (component 1 -- arms 1-4) and "KABP-6C" survey among adolescents and parents (arms 1-6)

Inclusion Criteria:

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

Exclusion Criteria:

* /

General practitioners' training (component 2) and "KABP-6C" survey among general practitioners (arms 1, 2 and 5)

Inclusion Criteria:

* General practitioners' practicing in the participating municipalities.

Exclusion Criteria:

* 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)

Inclusion Criteria:

* 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:

* Having initiated HPV vaccination.
* No written consent from parents/caregivers for vaccination.
* Contraindication to HPV vaccination.

Primary outcomes:
measure: HPV vaccine coverage (≥ 1 dose)
timeFrame: 2 months after intervention
Secondary outcomes:
measure: HPV vaccine coverage (≥ 1 dose)
timeFrame: 6 months and 12 months after intervention
measure: HPV vaccine coverage (2 doses)
timeFrame: 2 months, 6 months and 12 months after intervention
measure: HPV vaccination intention
timeFrame: Before intervention and 2 months after intervention
measure: Knowledge, attitude, beliefs and practices towards HPV vaccination and psychological determinants of vaccination intention ("KABP-6C")
timeFrame: Before intervention and 2 months after intervention
measure: Incremental Cost-Effectiveness Ratio
timeFrame: 2 months after intervention
measure: Intervention components' dose and fidelity
timeFrame: Intervention components' implementation period
measure: Reached populations
timeFrame: Intervention components' implementation period
measure: Intervention components' adaptation
timeFrame: Intervention components' implementation period
measure: Satisfaction of target populations about the activities / tools, assessed by a 4-point Likert scale
timeFrame: End of the intervention components' implementation period
Other outcomes:
Locations:
city: Participating Municipalities
country: France
facility: Secondary schools and GPs' practices of the participating municipalities
Study officials:
affiliation: EA 4360 APEMAC - Université de Lorraine, Nancy
name: Nathalie THILLY, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Département de Médecine Générale - Université Paris, Paris
name: Serge GILBERG, Pr
role: STUDY_DIRECTOR
affiliation: Université Grenoble Alpes, LIP/PC2S, EA 4145, Grenoble
name: Aurélie GAUCHET, Dr
role: STUDY_DIRECTOR
affiliation: Centre Régional de Coordination des Dépistages des cancers-Pays de la Loire, Angers
name: Anne-Sophie LE DUC-BANASZUK, Dr
role: STUDY_DIRECTOR
affiliation: GIMAP, EA 3064, Université Jean Monnet, Université de Lyon, Saint-Etienne, France
name: Amandine GAGNEUX-BRUNON, Dr
role: STUDY_DIRECTOR
affiliation: INSERM, ECEVE UMR 1123, Paris
name: Karine CHEVREUL, Pr
role: STUDY_DIRECTOR
affiliation: Unité de Recherche et d'Expertise Epidémiologie des maladies émergentes, Institut Pasteur, Paris
name: Judith MUELLER, Dr
role: STUDY_DIRECTOR
affiliation: INSERM CIC 1415, CHRU de Tours, Tours, France
name: Bruno GIRAUDEAU, Pr
role: STUDY_DIRECTOR
References:
citation: 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.