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

HPV Vaccine Acceptability Clinical Trial

— PrevHPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04945655
• Other study ID #: C20-76
• Secondary ID: 2020-A02031-38
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: July 2023
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30739
• Est. completion date: April 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• HPV Vaccine Acceptability

Intervention

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).
• 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.
• 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.

Locations

Country	Name	City	State
France	Secondary schools and GPs' practices of the participating municipalities	Participating Municipalities

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	6 months and 12 months after intervention
Secondary	HPV vaccine coverage (2 doses)	Percentage of adolescents aged 11-14 years, living in the municipality, who have received two doses of HPV vaccine	2 months, 6 months and 12 months after intervention
Secondary	HPV vaccination intention	Percentage of each group of participants (adolescents, parents and general practitioners) who have the intention to initiate/have their child vaccinated/recommend HPV vaccination	Before intervention and 2 months after intervention
Secondary	Knowledge, attitude, beliefs and practices towards HPV vaccination and psychological determinants of vaccination intention ("KABP-6C")	Each group participants' (adolescents, parents and general practitioners) knowledge and attitude towards HPV vaccination will be assessed for each of the " 6-C " components (Confidence, Complacency, Constraints, Calculation, Collective responsibility and social Conformism). Following results from otherwise onging research on psychological antecedents of vaccination, a 7 th C has been identified, refering to Confidence in the system (including reactance). The 6C thus has been extended to a 7C scale.; In addition to analysis of individual items, a score of knowledge (from 0 - poor knowledge -- to 12 -- good knowledge) and a score of attitude (from 0 - unfavourable attitude -- to 24 - very favourable attitude) will then be calculated. Practices towards HPV vaccination (self-declared vaccination status / recommendation to patients) will be assessed using closed questions. Data will be collected using ad hoc self-administered online KABP-7C questionnaires.	Before intervention and 2 months after intervention
Secondary	Incremental Cost-Effectiveness Ratio	Incremental Cost-Effectiveness Ratio	2 months after intervention
Secondary	Intervention components' dose and fidelity	Number of different activities really performed for each component / number of activities planned for each component according to the protocol. Data come from regular activity reports collected on a standardised form during components' implementation.	Intervention components' implementation period
Secondary	Reached populations	Percentage of target individuals who benefit from (or participate in) activities of each component (assessment of the acceptability of each component)	Intervention components' implementation period
Secondary	Intervention components' adaptation	Number of activities performed which have been modified to adapt them to the local context / total number of activities performed. A description of the adaptations performed will be provided. Data come from regular activity reports collected on a standardised form during components' implementation.	Intervention components' implementation period
Secondary	Satisfaction of target populations about the activities / tools, assessed by a 4-point Likert scale	Percentage of target individuals (adolescents, parents and general practitioners) who declare to be satisfied with each activity / tool (e.g., satisfaction of adolescents and school staff about the vaccination day organized inside the school premises, satisfaction of general practitioners about the e-learning training session). Satisfaction will be collected using self-administered (paper or online) questionnaires.	End of the intervention components' implementation period