Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability
- Conditions
- HPV Vaccine Acceptability
- Interventions
- 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)
- Registration Number
- NCT04945655
- Lead Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30739
- Adolescents (school years 9-10), and parents of adolescents (school years 7-10) attending secondary schools in the participating municipalities.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Arm 2: component 1 + component 2 General practitioners' training (component 2) Adolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2) Arm 3: component 1 + component 3 Access to vaccination at school (component 3) Adolescents and parents' education and motivation at school (component 1) + Access to vaccination at school (component 3) Arm 1: component 1 + component 2 + component 3 Access to vaccination at school (component 3) Adolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2) + Access to vaccination at school (component 3) Arm 1: component 1 + component 2 + component 3 General practitioners' training (component 2) Adolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2) + Access to vaccination at school (component 3) Arm 2: component 1 + component 2 Adolescents and parents' education and motivation at school (component 1) Adolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2) Arm 3: component 1 + component 3 Adolescents and parents' education and motivation at school (component 1) Adolescents and parents' education and motivation at school (component 1) + Access to vaccination at school (component 3) Arm 1: component 1 + component 2 + component 3 Adolescents and parents' education and motivation at school (component 1) Adolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2) + Access to vaccination at school (component 3) Arm 4: component 1 Adolescents and parents' education and motivation at school (component 1) Adolescents and parents' education and motivation at school (component 1) Arm 5: component 2 General practitioners' training (component 2) General practitioners' training (component 2)
- Primary Outcome Measures
Name Time Method HPV vaccine coverage (≥ 1 dose) 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 Outcome Measures
Name Time Method HPV vaccine coverage (≥ 1 dose) 6 months and 12 months after intervention Percentage of adolescents aged 11-14 years, living in the municipality, who have received at least one dose of HPV vaccine
HPV vaccine coverage (2 doses) 2 months, 6 months and 12 months after intervention Percentage of adolescents aged 11-14 years, living in the municipality, who have received two doses of HPV vaccine
HPV vaccination intention Before intervention and 2 months after intervention Percentage of each group of participants (adolescents, parents and general practitioners) who have the intention to initiate/have their child vaccinated/recommend HPV vaccination
Intervention components' adaptation Intervention components' implementation period 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.
Satisfaction of target populations about the activities / tools, assessed by a 4-point Likert scale End of the intervention components' implementation period 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.
Knowledge, attitude, beliefs and practices towards HPV vaccination and psychological determinants of vaccination intention ("KABP-6C") Before intervention and 2 months after intervention 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.Incremental Cost-Effectiveness Ratio 2 months after intervention Incremental Cost-Effectiveness Ratio
Reached populations Intervention components' implementation period Percentage of target individuals who benefit from (or participate in) activities of each component (assessment of the acceptability of each component)
Intervention components' dose and fidelity Intervention components' implementation period 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.
Trial Locations
- Locations (1)
Secondary schools and GPs' practices of the participating municipalities
🇫🇷Participating Municipalities, France