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

Hospital Israelita Albert Einstein

Status: Enrolling

Conditions: Vaccine Refusal; Vaccine Hesitancy

Treatments: Other: Usual care; Behavioral: Active Students Education plus Teacher Training; Behavioral: Active Students Education; Behavioral: Basic Health Unit Active Orientation

Study type: Interventional

Funder types: Other

Identifiers

NCT06513494

EDUCAVAC trial

Details and patient eligibility

About

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.

Full description

The adherence to the HPV vaccine among young people has declined recently, particularly in Brazil. While previous studies have shown that interventions such as text messaging can increase vaccination coverage, there is still a lack of robust data on the effectiveness of direct interventions in school populations using active health education methods. 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 80 schools across Brazil, including a total of 5,000 students. These schools will be randomized into clusters of five.

The study will apply a stepped-wedge implementation design, with clusters being randomized every two months to one of four interventions:

Education for students and teachers training + Basic Health Unit action in schools Education for students without teachers training + Basic Health Unit action in schools Only Basic Health Unit activities Usual control

Enrollment: 5,000 estimated patients

Sex: All

Ages: 9 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Criteria for students

Inclusion Criteria:

• Students of both sexes aged 9 to 14 years old.

Exclusion Criteria:

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

Criteria for Clusters

Inclusion Criteria:

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

Exclusion Criteria:

• Schools that do not have students aged between 9 and 14;
• Schools that provided only distance education

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5,000 participants in 4 patient groups

Active Students Education plus Teacher Training

Experimental group

Description:

Clusters will perform active training for both teachers and students.

Treatment:

Behavioral: Active Students Education plus Teacher Training

Active Students Education

Experimental group

Description:

Clusters will perform active training for only students.

Treatment:

Behavioral: Active Students Education

Basic Health Unit Active Orientation

Experimental group

Description:

Clusters will receive a nurse-led orientation session on vaccination for students in schools.

Treatment:

Behavioral: Basic Health Unit Active Orientation

Usual care

Other group

Description:

No project interventions will be carried out.

Treatment:

Other: Usual care