Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial
EDUCAVAC
A Stepped-wedge, Cluster, and Randomized Trial to Evaluate Active Health Education Methods to Increase Human Papillomavirus Vaccine Coverage in Youth
1 other identifier
interventional
5,000
1 country
79
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2024
CompletedFirst Posted
Study publicly available on registry
July 22, 2024
CompletedStudy Start
First participant enrolled
March 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedNovember 18, 2025
March 1, 2025
8 months
July 16, 2024
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention
Rate of HPV vaccination among childrens and adolescents
12 months
Secondary Outcomes (4)
Proportion of children and adolescents with complete HPV vaccination
12 months
Proportion of teachers with complete HPV vaccination (two doses)
12 months
Proportion of vaccination refusal among children and adolescents
12 months
Proportion of vaccination refusal among teachers
12 months
Study Arms (4)
Active Students Education plus Teacher Training
EXPERIMENTALClusters will perform active training for both teachers and students.
Active Students Education
EXPERIMENTALClusters will perform active training for only students.
Basic Health Unit Active Orientation
EXPERIMENTALClusters will receive a nurse-led orientation session on vaccination for students in schools.
Usual care
OTHERNo project interventions will be carried out.
Interventions
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
Students receive active vaccinations and health education over two months.
Nurses from basic health units will conduct an active orientation session at schools about vaccination for students.
Eligibility Criteria
You may qualify if:
- Students of both sexes aged 9 to 14 years old.
You may not qualify if:
- Students with a complete HPV vaccination (two doses) received.
- Criteria for Clusters
- The school has enrolled students aged 9 to 14 years old.
- Schools that do not have students aged between 9 and 14;
- Schools that provided only distance education
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Israelita Albert Einsteinlead
- Ministry of Health, Brazilcollaborator
Study Sites (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
CED 4 do Guará
Brasília, Federal District, Brazil
CEF 04 Ceilandia
Brasília, Federal District, Brazil
CEF 2 da estrutural
Brasília, Federal District, Brazil
CEF 3 da Estrutural
Brasília, Federal District, Brazil
CEF 4 Guará
Brasília, Federal District, Brazil
CEF Lobo Guará
Brasília, Federal District, Brazil
CEF Santos Dumont
Brasília, Federal District, Brazil
CEF Telebrasília
Brasília, Federal District, Brazil
CEF Vargem Bonita
Brasília, Federal District, Brazil
Cei 02 - Prof João Crisóstomo de Figueiredo
Cuiabá, Mato Grosso, Brazil
Ee Ana Maria Do Couto
Cuiabá, Mato Grosso, Brazil
Ee Mariana Luiza Moreira
Cuiabá, Mato Grosso, Brazil
EE PROFª DIVA HUGUENEY DE SIQUEIRA BASTOS
Cuiabá, Mato Grosso, Brazil
EE PROFº RAFAEL RUEDA
Cuiabá, Mato Grosso, Brazil
Ee Deputado Milton Figueiredo
Várzea Grande, Mato Grosso, Brazil
EE Tancredo de Almeida Neves
Couto de Magalhães de Minas, Minas Gerais, Brazil
EM São Judas Tadeu
Couto de Magalhães de Minas, Minas Gerais, Brazil
EE Arthur Tibães
Diamantina, Minas Gerais, Brazil
EE João Cesar de Oliveira
Diamantina, Minas Gerais, Brazil
EE Professor Gabriel Madacaru
Diamantina, Minas Gerais, Brazil
EE Professor Leopoldo Miranda
Diamantina, Minas Gerais, Brazil
EE Professora Gabriela Neves
Diamantina, Minas Gerais, Brazil
Escola Estadual Professora Isabel Motta
Diamantina, Minas Gerais, Brazil
EE Felício dos Santos
Felício dos Santos, Minas Gerais, Brazil
EM Santo Antônio
Felício dos Santos, Minas Gerais, Brazil
EE Dom João Antônio dos Santo
São Gonçalo do Rio Preto, Minas Gerais, Brazil
EM Zulma Rocha dos Santos
São Gonçalo do Rio Preto, Minas Gerais, Brazil
CE C-M-Ef M Profis Jose Elias da Rocha
Ponta Grossa, Paraná, Brazil
CE Pe-Ef M Pedro Grzelczaki
Ponta Grossa, Paraná, Brazil
CE Prof-Ef M Profis Meneleu A Torres
Ponta Grossa, Paraná, Brazil
CE Prof-Ef M Profis. Joao R V B du Vernay
Ponta Grossa, Paraná, Brazil
EE Profa-Ef Halia T Gruba
Ponta Grossa, Paraná, Brazil
EE-Ef Jesus Divino Operario
Ponta Grossa, Paraná, Brazil
EM Doutor Leopoldo Pinto Rosas
Ponta Grossa, Paraná, Brazil
EM Professora Agenoridas Stadler
Ponta Grossa, Paraná, Brazil
EM Professora Cristiane Levandowski
Ponta Grossa, Paraná, Brazil
EM Professora Zair Santos Nascimento
Ponta Grossa, Paraná, Brazil
EM Professora Zanoni Rogoski
Ponta Grossa, Paraná, Brazil
EM Alfredo Monteiro de Seixas
Augusto Corrêa, Pará, Brazil
EM Andre Alves
Augusto Corrêa, Pará, Brazil
EM Carmem Dilce
Augusto Corrêa, Pará, Brazil
EM Manoel Sady
Augusto Corrêa, Pará, Brazil
EM Maria Benedita Mota
Augusto Corrêa, Pará, Brazil
EM Maria da Conceição Santana
Augusto Corrêa, Pará, Brazil
EM Rosa Athayde
Augusto Corrêa, Pará, Brazil
EM Edom do Nascimento Pinheiro
Tracuateua, Pará, Brazil
EM Elias Ferez Gorayeb
Tracuateua, Pará, Brazil
EM Levina de Oliveira Reis
Tracuateua, Pará, Brazil
EM Valdemar Pinheiro da Silva
Tracuateua, Pará, Brazil
EM Zulmira Guedes
Tracuateua, Pará, Brazil
EE Alceu Amoroso Lima
Natal, Rio Grande do Norte, Brazil
EE Aldo Fernandes
Natal, Rio Grande do Norte, Brazil
EE Djalma Aranha Marinho
Natal, Rio Grande do Norte, Brazil
EE Isabel Gondim
Natal, Rio Grande do Norte, Brazil
EE Reginaldo Ferreira Neto
Natal, Rio Grande do Norte, Brazil
EM Ferreira Itajubá
Natal, Rio Grande do Norte, Brazil
EM José Alves Landim
Natal, Rio Grande do Norte, Brazil
EM José do Patrocínio Pereira Pinto
Natal, Rio Grande do Norte, Brazil
EM Professora Lourdes Godeiro
Natal, Rio Grande do Norte, Brazil
Cem Iii Irmã Maria Teresa Parodi
Boa Vista, Roraima, Brazil
Ee Fagundes Varela
Boa Vista, Roraima, Brazil
Ee Jesus Nazareno de Souza Cruz
Boa Vista, Roraima, Brazil
Em Valdemarina Normando Martins
Boa Vista, Roraima, Brazil
Cem José Aureliano Da Costa
Cantá, Roraima, Brazil
Em Tia Ercília
Cantá, Roraima, Brazil
Cem Maria Mariselma de Oliveira Cruz
Mucajaí, Roraima, Brazil
Ee Vereador Francisco Pereira Lima
Mucajaí, Roraima, Brazil
Em Irmã Leonilde Dal Pós
Mucajaí, Roraima, Brazil
Em Jesus de Nazaré
Mucajaí, Roraima, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2024
First Posted
July 22, 2024
Study Start
March 24, 2025
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
November 18, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share