Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial
NCT ID: NCT06513494
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
5000 participants
INTERVENTIONAL
2025-03-24
2026-12-01
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Active Students Education plus Teacher Training
Clusters will perform active training for both teachers and students.
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
Active Students Education
Clusters will perform active training for only students.
Active Students Education
Students receive active vaccinations and health education over two months.
Basic Health Unit Active Orientation
Clusters will receive a nurse-led orientation session on vaccination for students in schools.
Basic Health Unit Active Orientation
Nurses from basic health units will conduct an active orientation session at schools about vaccination for students.
Usual care
No project interventions will be carried out.
Usual care
No project interventions will be carried out.
Interventions
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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
Active Students Education
Students receive active vaccinations and health education over two months.
Basic Health Unit Active Orientation
Nurses from basic health units will conduct an active orientation session at schools about vaccination for students.
Usual care
No project interventions will be carried out.
Eligibility Criteria
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Inclusion Criteria
* The school has enrolled students aged 9 to 14 years old.
Exclusion Criteria
Criteria for Clusters
* Schools that do not have students aged between 9 and 14;
* Schools that provided only distance education
9 Years
14 Years
ALL
Yes
Sponsors
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Ministry of Health, Brazil
OTHER_GOV
Hospital Israelita Albert Einstein
OTHER
Responsible Party
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Principal Investigators
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Prof. Henrique A Fonseca, PhD
Role: STUDY_CHAIR
Academic Research Organization - Hospital Israelita Albert Einstein
Prof. Luiz V Rizzo, PhD
Role: STUDY_CHAIR
Academic Research Organization - Hospital Israelita Albert Einstein
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EDUCAVAC trial
Identifier Type: -
Identifier Source: org_study_id
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