Health TrialsbyHealthPanel

Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial

ConditionsVaccine RefusalVaccine Hesitancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-14
SponsorHospital Israelita Albert Einstein

About this trial

This study aims to evaluate the impact of active health education methodologies on increasing adherence to the HPV vaccine among schoolchildren. The project will involve 196 schools across Brazil, encompassing a total of 5,000 students.

A stepped-wedge implementation design will be applied, with clusters being randomized every two months to one of four interventions.

Each intervention will be implemented in 48 schools.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Students of both sexes aged 9 to 14 years old.

Disqualifiers

Students with a complete HPV vaccination (two doses) received.

The school has enrolled students aged 9 to 14 years old.

Schools that do not have students aged between 9 and 14;

Schools that provided only distance education

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active Students Education plus Teacher Training

    Behavioral

    The teacher undergoes 30 hours of self-instructional training on vaccination through an online platform tailored for the relevant age group. Additionally, students receive active vaccinations and health education over two months

  • Active Students Education

    Behavioral

    Students receive active vaccinations and health education over two months.

  • Basic Health Unit Active Orientation

    Behavioral

    Nurses from basic health units will conduct an active orientation session at schools about vaccination for students.

  • Usual care

    Other intervention

    No project interventions will be carried out.

Treatment groups

5,000 Participants
are divided into 4 treatment groups
Group A: Active Students Education plus Teacher TrainingExperimental treatment 1 intervention
Group B: Active Students EducationExperimental treatment 1 intervention
Group C: Basic Health Unit Active OrientationExperimental treatment 1 intervention
Group D: Usual careOther 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention

Rate of HPV vaccination among childrens and adolescents

Time frame
12 months

Secondary outcomes

1

Proportion of children and adolescents with complete HPV vaccination

Rate of complete HPV vaccination scheme (two doses) among childrens and adolescents

Time frame
12 months
2

Proportion of teachers with complete HPV vaccination (two doses)

Rate of complete HPV vaccination scheme (two doses) among teachers

Time frame
12 months
3

Proportion of vaccination refusal among children and adolescents

Rate of HPV vaccination refusal

Time frame
12 months
4

Proportion of vaccination refusal among teachers

Rate of teacher HPV vaccination refusal

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Israelita Albert Einstein

Lead sponsor

Ministry of Health, Brazil

Collaborator

Source ClinicalTrials.gov
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