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

November 14, 2025 updated by: Hospital Israelita Albert Einstein

A Stepped-wedge, Cluster, and Randomized Trial to Evaluate Active Health Education Methods to Increase Human Papillomavirus Vaccine Coverage in Youth

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

5000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Ceará
      • Crato, Ceará, Brazil
        • Recruiting
        • Cel Filemon Fernandes Teles
        • Contact:
      • Crato, Ceará, Brazil
        • Recruiting
        • Dom Vicente de Paula Araujo Matos
        • Contact:
      • Crato, Ceará, Brazil
        • Recruiting
        • EEIEF Maria Yara de Brito Gonçalves CAIC
        • Contact:
      • Crato, Ceará, Brazil
        • Recruiting
        • EEIF Antonio Antuérpio Gonzaga de Melo
        • Contact:
      • Juazeiro do Norte, Ceará, Brazil
        • Recruiting
        • EEF José Ferreira Menezes
        • Contact:
      • Juazeiro do Norte, Ceará, Brazil
        • Recruiting
        • EEF Raimundo Pessoa
        • Contact:
      • Juazeiro do Norte, Ceará, Brazil
        • Recruiting
        • EEF Zila Belem
        • Contact:
      • Juazeiro do Norte, Ceará, Brazil
        • Recruiting
        • Emef Mário Da Silva Bem
        • Contact:
      • Juazeiro do Norte, Ceará, Brazil
        • Recruiting
        • Emef Professora Maria de Lourdes Lopes de Sousa
        • Contact:
      • Juazeiro do Norte, Ceará, Brazil
        • Recruiting
        • EMEIF Maria Do Socorro Cardoso
        • Contact:
    • Federal District
      • Brasília, Federal District, Brazil
      • Brasília, Federal District, Brazil
      • Brasília, Federal District, Brazil
      • Brasília, Federal District, Brazil
      • Brasília, Federal District, Brazil
      • Brasília, Federal District, Brazil
      • Brasília, Federal District, Brazil
      • Brasília, Federal District, Brazil
      • Brasília, Federal District, Brazil
    • Mato Grosso
      • Cuiabá, Mato Grosso, Brazil
        • Recruiting
        • Cei 02 - Prof João Crisóstomo de Figueiredo
        • Contact:
      • Cuiabá, Mato Grosso, Brazil
        • Recruiting
        • Ee Ana Maria Do Couto
        • Contact:
      • Cuiabá, Mato Grosso, Brazil
        • Recruiting
        • Ee Mariana Luiza Moreira
        • Contact:
      • Cuiabá, Mato Grosso, Brazil
        • Recruiting
        • EE PROFª DIVA HUGUENEY DE SIQUEIRA BASTOS
        • Contact:
      • Cuiabá, Mato Grosso, Brazil
        • Recruiting
        • EE PROFº RAFAEL RUEDA
        • Contact:
      • Várzea Grande, Mato Grosso, Brazil
        • Recruiting
        • Ee Deputado Milton Figueiredo
        • Contact:
    • Minas Gerais
      • Couto de Magalhães de Minas, Minas Gerais, Brazil
      • Couto de Magalhães de Minas, Minas Gerais, Brazil
      • Diamantina, Minas Gerais, Brazil
      • Diamantina, Minas Gerais, Brazil
      • Diamantina, Minas Gerais, Brazil
      • Diamantina, Minas Gerais, Brazil
      • Diamantina, Minas Gerais, Brazil
      • Diamantina, Minas Gerais, Brazil
      • Felício dos Santos, Minas Gerais, Brazil
      • Felício dos Santos, Minas Gerais, Brazil
      • São Gonçalo do Rio Preto, Minas Gerais, Brazil
      • São Gonçalo do Rio Preto, Minas Gerais, Brazil
    • Paraná
      • Ponta Grossa, Paraná, Brazil
        • Recruiting
        • CE C-M-Ef M Profis Jose Elias da Rocha
        • Contact:
      • Ponta Grossa, Paraná, Brazil
        • Recruiting
        • CE Pe-Ef M Pedro Grzelczaki
        • Contact:
      • Ponta Grossa, Paraná, Brazil
        • Recruiting
        • CE Prof-Ef M Profis Meneleu A Torres
        • Contact:
      • Ponta Grossa, Paraná, Brazil
        • Recruiting
        • CE Prof-Ef M Profis. Joao R V B du Vernay
        • Contact:
      • Ponta Grossa, Paraná, Brazil
        • Recruiting
        • EE Profa-Ef Halia T Gruba
        • Contact:
      • Ponta Grossa, Paraná, Brazil
        • Recruiting
        • EE-Ef Jesus Divino Operario
        • Contact:
      • Ponta Grossa, Paraná, Brazil
        • Recruiting
        • EM Doutor Leopoldo Pinto Rosas
        • Contact:
      • Ponta Grossa, Paraná, Brazil
        • Recruiting
        • EM Professora Agenoridas Stadler
        • Contact:
      • Ponta Grossa, Paraná, Brazil
        • Recruiting
        • EM Professora Cristiane Levandowski
        • Contact:
      • Ponta Grossa, Paraná, Brazil
        • Recruiting
        • EM Professora Zair Santos Nascimento
        • Contact:
      • Ponta Grossa, Paraná, Brazil
        • Recruiting
        • EM Professora Zanoni Rogoski
        • Contact:
    • Pará
      • Augusto Corrêa, Pará, Brazil
        • Recruiting
        • EM Alfredo Monteiro de Seixas
        • Contact:
      • Augusto Corrêa, Pará, Brazil
        • Recruiting
        • EM Andre Alves
        • Contact:
      • Augusto Corrêa, Pará, Brazil
        • Recruiting
        • EM Carmem Dilce
        • Contact:
      • Augusto Corrêa, Pará, Brazil
        • Recruiting
        • EM Manoel Sady
        • Contact:
      • Augusto Corrêa, Pará, Brazil
        • Recruiting
        • EM Maria Benedita Mota
        • Contact:
      • Augusto Corrêa, Pará, Brazil
        • Recruiting
        • EM Maria da Conceição Santana
        • Contact:
      • Augusto Corrêa, Pará, Brazil
        • Recruiting
        • EM Rosa Athayde
        • Contact:
      • Tracuateua, Pará, Brazil
        • Recruiting
        • EM Edom do Nascimento Pinheiro
        • Contact:
      • Tracuateua, Pará, Brazil
        • Recruiting
        • EM Elias Ferez Gorayeb
        • Contact:
      • Tracuateua, Pará, Brazil
        • Recruiting
        • EM Levina de Oliveira Reis
        • Contact:
      • Tracuateua, Pará, Brazil
        • Recruiting
        • EM Valdemar Pinheiro da Silva
        • Contact:
      • Tracuateua, Pará, Brazil
        • Recruiting
        • EM Zulmira Guedes
        • Contact:
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil
      • Natal, Rio Grande do Norte, Brazil
      • Natal, Rio Grande do Norte, Brazil
      • Natal, Rio Grande do Norte, Brazil
      • Natal, Rio Grande do Norte, Brazil
      • Natal, Rio Grande do Norte, Brazil
      • Natal, Rio Grande do Norte, Brazil
      • Natal, Rio Grande do Norte, Brazil
      • Natal, Rio Grande do Norte, Brazil
    • Roraima
      • Boa Vista, Roraima, Brazil
        • Recruiting
        • Cem Iii Irmã Maria Teresa Parodi
        • Contact:
      • Boa Vista, Roraima, Brazil
        • Recruiting
        • Ee Fagundes Varela
        • Contact:
      • Boa Vista, Roraima, Brazil
        • Recruiting
        • Ee Jesus Nazareno de Souza Cruz
        • Contact:
      • Boa Vista, Roraima, Brazil
        • Recruiting
        • Em Valdemarina Normando Martins
        • Contact:
      • Cantá, Roraima, Brazil
        • Recruiting
        • Cem José Aureliano Da Costa
        • Contact:
      • Cantá, Roraima, Brazil
        • Recruiting
        • Em Tia Ercília
        • Contact:
      • Mucajaí, Roraima, Brazil
        • Recruiting
        • Cem Maria Mariselma de Oliveira Cruz
        • Contact:
      • Mucajaí, Roraima, Brazil
        • Recruiting
        • Ee Vereador Francisco Pereira Lima
        • Contact:
      • Mucajaí, Roraima, Brazil
        • Recruiting
        • Em Irmã Leonilde Dal Pós
        • Contact:
          • Marcos A A +55 95 991445480, BSc
          • Phone Number: marcos2rr@gmail.com
      • Mucajaí, Roraima, Brazil
        • Recruiting
        • Em Jesus de Nazaré
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Students Education plus Teacher Training
Clusters will perform active training for both teachers and students.
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
Experimental: Active Students Education
Clusters will perform active training for only students.
Behavioral: Active Students Education
Students receive active vaccinations and health education over two months.
Experimental: Basic Health Unit Active Orientation
Clusters will receive a nurse-led orientation session on vaccination for students in schools.
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.
Other: Usual care
No project interventions will be carried out.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention
Time Frame: 12 months
Rate of HPV vaccination among childrens and adolescents
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of children and adolescents with complete HPV vaccination
Time Frame: 12 months
Rate of complete HPV vaccination scheme (two doses) among childrens and adolescents
12 months
Proportion of teachers with complete HPV vaccination (two doses)
Time Frame: 12 months
Rate of complete HPV vaccination scheme (two doses) among teachers
12 months
Proportion of vaccination refusal among children and adolescents
Time Frame: 12 months
Rate of HPV vaccination refusal
12 months
Proportion of vaccination refusal among teachers
Time Frame: 12 months
Rate of teacher HPV vaccination refusal
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Collaborators

Ministry of Health, Brazil

Investigators

  • Study Chair: Prof. Henrique A Fonseca, PhD, Academic Research Organization - Hospital Israelita Albert Einstein
  • Study Chair: Prof. Luiz V Rizzo, PhD, Academic Research Organization - Hospital Israelita Albert Einstein

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDUCAVAC trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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