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

Not Applicable

Recruiting

• Conditions: Vaccine Refusal; Vaccine Hesitancy

• Registration Number: NCT06513494
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Status Verified: 2025-03
• Study Start: 2025-03-24
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention	12 months	Rate of HPV vaccination among childrens and adolescents

Secondary Outcome Measures

Name	Time	Method
Proportion of teachers with complete HPV vaccination (two doses)	12 months	Rate of complete HPV vaccination scheme (two doses) among teachers
Proportion of children and adolescents with complete HPV vaccination	12 months	Rate of complete HPV vaccination scheme (two doses) among childrens and adolescents
Proportion of vaccination refusal among teachers	12 months	Rate of teacher HPV vaccination refusal
Proportion of vaccination refusal among children and adolescents	12 months	Rate of HPV vaccination refusal

Trial Locations

Locations (79)

Cel Filemon Fernandes Teles; 🇧🇷 Crato, Ceará, Brazil

Dom Vicente de Paula Araujo Matos; 🇧🇷 Crato, Ceará, Brazil

EEIEF Maria Yara de Brito Gonçalves CAIC; 🇧🇷 Crato, Ceará, Brazil

EEIF Antonio Antuérpio Gonzaga de Melo; 🇧🇷 Crato, Ceará, Brazil

EEF José Ferreira Menezes; 🇧🇷 Juazeiro do Norte, Ceará, Brazil

EEF Raimundo Pessoa; 🇧🇷 Juazeiro do Norte, Ceará, Brazil

EEF Zila Belem; 🇧🇷 Juazeiro do Norte, Ceará, Brazil

Emef Mário Da Silva Bem; 🇧🇷 Juazeiro do Norte, Ceará, Brazil

Emef Professora Maria de Lourdes Lopes de Sousa; 🇧🇷 Juazeiro do Norte, Ceará, Brazil

EMEIF Maria Do Socorro Cardoso; 🇧🇷 Juazeiro do Norte, Ceará, Brazil

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