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

NCT06513494 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2025-11-18

No results posted yet for this study

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 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.

Conditions

  • Vaccine Refusal
  • Vaccine Hesitancy

Interventions

BEHAVIORAL

Active Students Education plus Teacher Training

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

BEHAVIORAL

Active Students Education

Students receive active vaccinations and health education over two months.

BEHAVIORAL

Basic Health Unit Active Orientation

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

OTHER

Usual care

No project interventions will be carried out.

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Prof. Henrique A Fonseca, PhD · Academic Research Organization - Hospital Israelita Albert Einstein

  • Prof. Luiz V Rizzo, PhD · Academic Research Organization - Hospital Israelita Albert Einstein

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-24
Primary Completion
2025-12-01
Completion
2026-12-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06513494 on ClinicalTrials.gov