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

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

Recruiting
9-14 years
All
Phase N/A

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Overview

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, 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 20 schools.

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

Eligibility

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

Study details
    Vaccine Refusal
    Vaccine Hesitancy

NCT06513494

Hospital Israelita Albert Einstein

15 October 2025

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