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

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

Status: Completed

Conditions: HPV Vaccine Acceptability

Treatments: Other: General practitioners' training (component 2); Other: Adolescents and parents' education and motivation at school (component 1); Other: Access to vaccination at school (component 3)

Study type: Interventional

Funder types: Other

Identifiers

NCT04945655

C20-76

2020-A02031-38 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 30,739 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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30,739 participants in 6 patient groups

Arm 1: component 1 + component 2 + component 3

Experimental group

Description:

Adolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2) + Access to vaccination at school (component 3)

Treatment:

Other: Access to vaccination at school (component 3)

Other: Adolescents and parents' education and motivation at school (component 1)

Other: General practitioners' training (component 2)

Arm 2: component 1 + component 2

Experimental group

Description:

Adolescents and parents' education and motivation at school (component 1) + General practitioners' training (component 2)

Treatment:

Other: Adolescents and parents' education and motivation at school (component 1)

Other: General practitioners' training (component 2)

Arm 3: component 1 + component 3

Experimental group

Description:

Adolescents and parents' education and motivation at school (component 1) + Access to vaccination at school (component 3)

Treatment:

Other: Access to vaccination at school (component 3)

Other: Adolescents and parents' education and motivation at school (component 1)

Arm 4: component 1

Experimental group

Description:

Adolescents and parents' education and motivation at school (component 1)

Treatment:

Other: Adolescents and parents' education and motivation at school (component 1)

Arm 5: component 2

Experimental group

Description:

General practitioners' training (component 2)

Treatment:

Other: General practitioners' training (component 2)

Arm 6: Control

No Intervention group

Description:

No intervention