Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability Among French Adolescents: a Cluster Randomized Controlled Trial

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country30,739 target enrollmentNovember 15, 2021

ConditionsHPV Vaccine Acceptability

Overview

Phase: N/A
Intervention: Not specified
Conditions: HPV Vaccine Acceptability
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Enrollment: 30739
Locations: 1
Primary Endpoint: HPV vaccine coverage (≥ 1 dose)
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 15, 2021

End Date

April 30, 2023

Last Updated

4 months ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

HPV vaccine coverage (≥ 1 dose)

Time Frame: 2 months after intervention

Percentage of adolescents aged 11-14 years, living in the municipality, who have received at least one dose of HPV vaccine

Secondary Outcomes

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)
Intervention components' adaptation(Intervention components' implementation period)
Satisfaction of target populations about the activities / tools, assessed by a 4-point Likert scale(End of the intervention components' implementation period)
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)
Reached populations(Intervention components' implementation period)
Intervention components' dose and fidelity(Intervention components' implementation period)