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

Study Overview
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Brief Summary
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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.

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

Conditions
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HPV Vaccine Acceptability

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Multicentre cluster randomized controlled trial using an incomplete factorial design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: component 1 + component 2 + component 3<br>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)<br>* 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).<br>Other: General practitioners' training (component 2)<br>* 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.<br>Other: Access to vaccination at school (component 3)<br>* 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.<br>|
| Experimental: Arm 2: component 1 + component 2<br>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)<br>* 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).<br>Other: General practitioners' training (component 2)<br>* 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.<br>|
| Experimental: Arm 3: component 1 + component 3<br>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)<br>* 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).<br>Other: Access to vaccination at school (component 3)<br>* 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.<br>|
| Experimental: Arm 4: component 1<br>Adolescents and parents' education and motivation at school (component 1) | Other: Adolescents and parents' education and motivation at school (component 1)<br>* 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).<br>|
| Experimental: Arm 5: component 2<br>General practitioners' training (component 2) | Other: General practitioners' training (component 2)<br>* 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.<br>|
| No Intervention: Arm 6: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Incremental Cost-Effectiveness Ratio | Incremental Cost-Effectiveness Ratio | 2 months after intervention | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papillomavirus, Vaccination coverage, eHealth tools, Motivational interview, Pragmatic randomized controlled trial, Effectiveness, Implementation, Vaccination behaviors