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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Students Education plus Teacher Training | Experimental | Clusters will perform active training for both teachers and students. |
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| Active Students Education | Experimental | Clusters will perform active training for only students. |
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| Basic Health Unit Active Orientation | Experimental | Clusters will receive a nurse-led orientation session on vaccination for students in schools. |
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| Usual care | Other | No project interventions will be carried out. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Students Education plus Teacher Training | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of children and adolescents with complete HPV vaccination | Rate of complete HPV vaccination scheme (two doses) among childrens and adolescents | 12 months |
| Proportion of teachers with complete HPV vaccination (two doses) |
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Criteria for students
Inclusion Criteria:
Exclusion Criteria:
Criteria for Clusters
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soraya S Cruz | Contact | 55 11 2151-1233 | ARO | soraya.cruz@einstein.br |
| Henrique A Fonseca | Contact | 55 11 2151-1233 | henrique.fonseca@einstein.br |
| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cel Filemon Fernandes Teles | Recruiting | Crato | Ceará | Brazil |
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Stepped-wedge, Cluster, and Randomized trial
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| Active Students Education | Behavioral | Students receive active vaccinations and health education over two months. |
|
| Basic Health Unit Active Orientation | Behavioral | Nurses from basic health units will conduct an active orientation session at schools about vaccination for students. |
|
| Usual care | Other | No project interventions will be carried out. |
|
Rate of complete HPV vaccination scheme (two doses) among teachers
| 12 months |
| Proportion of vaccination refusal among children and adolescents | Rate of HPV vaccination refusal | 12 months |
| Proportion of vaccination refusal among teachers | Rate of teacher HPV vaccination refusal | 12 months |
| Dom Vicente de Paula Araujo Matos | Recruiting | Crato | Ceará | Brazil |
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| EEIEF Maria Yara de Brito Gonçalves CAIC | Recruiting | Crato | Ceará | Brazil |
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| EEIF Antonio Antuérpio Gonzaga de Melo | Recruiting | Crato | Ceará | Brazil |
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| EEF José Ferreira Menezes | Recruiting | Juazeiro do Norte | Ceará | Brazil |
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| EEF Raimundo Pessoa | Recruiting | Juazeiro do Norte | Ceará | Brazil |
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| EEF Zila Belem | Recruiting | Juazeiro do Norte | Ceará | Brazil |
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| Emef Mário Da Silva Bem | Recruiting | Juazeiro do Norte | Ceará | Brazil |
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| Emef Professora Maria de Lourdes Lopes de Sousa | Recruiting | Juazeiro do Norte | Ceará | Brazil |
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| EMEIF Maria Do Socorro Cardoso | Recruiting | Juazeiro do Norte | Ceará | Brazil |
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| CED 4 do Guará | Recruiting | Brasília | Federal District | Brazil |
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| CEF 04 Ceilandia | Recruiting | Brasília | Federal District | Brazil |
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| CEF 2 da estrutural | Recruiting | Brasília | Federal District | Brazil |
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| CEF 3 da Estrutural | Recruiting | Brasília | Federal District | Brazil |
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| CEF 4 Guará | Recruiting | Brasília | Federal District | Brazil |
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| CEF Lobo Guará | Recruiting | Brasília | Federal District | Brazil |
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| CEF Santos Dumont | Recruiting | Brasília | Federal District | Brazil |
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| CEF Telebrasília | Recruiting | Brasília | Federal District | Brazil |
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| CEF Vargem Bonita | Recruiting | Brasília | Federal District | Brazil |
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| Cei 02 - Prof João Crisóstomo de Figueiredo | Recruiting | Cuiabá | Mato Grosso | Brazil |
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| Ee Ana Maria Do Couto | Recruiting | Cuiabá | Mato Grosso | Brazil |
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| Ee Mariana Luiza Moreira | Recruiting | Cuiabá | Mato Grosso | Brazil |
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| EE PROFª DIVA HUGUENEY DE SIQUEIRA BASTOS | Recruiting | Cuiabá | Mato Grosso | Brazil |
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| EE PROFº RAFAEL RUEDA | Recruiting | Cuiabá | Mato Grosso | Brazil |
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| Ee Deputado Milton Figueiredo | Recruiting | Várzea Grande | Mato Grosso | Brazil |
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| EE Tancredo de Almeida Neves | Recruiting | Couto de Magalhães de Minas | Minas Gerais | Brazil |
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| EM São Judas Tadeu | Recruiting | Couto de Magalhães de Minas | Minas Gerais | Brazil |
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| EE Arthur Tibães | Recruiting | Diamantina | Minas Gerais | Brazil |
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| EE João Cesar de Oliveira | Recruiting | Diamantina | Minas Gerais | Brazil |
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| EE Professor Gabriel Madacaru | Recruiting | Diamantina | Minas Gerais | Brazil |
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| EE Professor Leopoldo Miranda | Recruiting | Diamantina | Minas Gerais | Brazil |
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| EE Professora Gabriela Neves | Recruiting | Diamantina | Minas Gerais | Brazil |
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| Escola Estadual Professora Isabel Motta | Recruiting | Diamantina | Minas Gerais | Brazil |
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| EE Felício dos Santos | Recruiting | Felício dos Santos | Minas Gerais | Brazil |
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| EM Santo Antônio | Recruiting | Felício dos Santos | Minas Gerais | Brazil |
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| EE Dom João Antônio dos Santo | Recruiting | São Gonçalo do Rio Preto | Minas Gerais | Brazil |
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| EM Zulma Rocha dos Santos | Recruiting | São Gonçalo do Rio Preto | Minas Gerais | Brazil |
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| CE C-M-Ef M Profis Jose Elias da Rocha | Recruiting | Ponta Grossa | Paraná | Brazil |
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| CE Pe-Ef M Pedro Grzelczaki | Recruiting | Ponta Grossa | Paraná | Brazil |
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| CE Prof-Ef M Profis Meneleu A Torres | Recruiting | Ponta Grossa | Paraná | Brazil |
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| CE Prof-Ef M Profis. Joao R V B du Vernay | Recruiting | Ponta Grossa | Paraná | Brazil |
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| EE Profa-Ef Halia T Gruba | Recruiting | Ponta Grossa | Paraná | Brazil |
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| EE-Ef Jesus Divino Operario | Recruiting | Ponta Grossa | Paraná | Brazil |
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| EM Doutor Leopoldo Pinto Rosas | Recruiting | Ponta Grossa | Paraná | Brazil |
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| EM Professora Agenoridas Stadler | Recruiting | Ponta Grossa | Paraná | Brazil |
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| EM Professora Cristiane Levandowski | Recruiting | Ponta Grossa | Paraná | Brazil |
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| EM Professora Zair Santos Nascimento | Recruiting | Ponta Grossa | Paraná | Brazil |
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| EM Professora Zanoni Rogoski | Recruiting | Ponta Grossa | Paraná | Brazil |
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| EM Alfredo Monteiro de Seixas | Recruiting | Augusto Corrêa | Pará | Brazil |
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| EM Andre Alves | Recruiting | Augusto Corrêa | Pará | Brazil |
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| EM Carmem Dilce | Recruiting | Augusto Corrêa | Pará | Brazil |
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| EM Manoel Sady | Recruiting | Augusto Corrêa | Pará | Brazil |
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| EM Maria Benedita Mota | Recruiting | Augusto Corrêa | Pará | Brazil |
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| EM Maria da Conceição Santana | Recruiting | Augusto Corrêa | Pará | Brazil |
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| EM Rosa Athayde | Recruiting | Augusto Corrêa | Pará | Brazil |
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| EM Edom do Nascimento Pinheiro | Recruiting | Tracuateua | Pará | Brazil |
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| EM Elias Ferez Gorayeb | Recruiting | Tracuateua | Pará | Brazil |
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| EM Levina de Oliveira Reis | Recruiting | Tracuateua | Pará | Brazil |
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| EM Valdemar Pinheiro da Silva | Recruiting | Tracuateua | Pará | Brazil |
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| EM Zulmira Guedes | Recruiting | Tracuateua | Pará | Brazil |
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| EE Alceu Amoroso Lima | Recruiting | Natal | Rio Grande do Norte | Brazil |
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| EE Aldo Fernandes | Recruiting | Natal | Rio Grande do Norte | Brazil |
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| EE Djalma Aranha Marinho | Recruiting | Natal | Rio Grande do Norte | Brazil |
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| EE Isabel Gondim | Recruiting | Natal | Rio Grande do Norte | Brazil |
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| EE Reginaldo Ferreira Neto | Recruiting | Natal | Rio Grande do Norte | Brazil |
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| EM Ferreira Itajubá | Recruiting | Natal | Rio Grande do Norte | Brazil |
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| EM José Alves Landim | Recruiting | Natal | Rio Grande do Norte | Brazil |
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| EM José do Patrocínio Pereira Pinto | Recruiting | Natal | Rio Grande do Norte | Brazil |
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| EM Professora Lourdes Godeiro | Recruiting | Natal | Rio Grande do Norte | Brazil |
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| Cem Iii Irmã Maria Teresa Parodi | Recruiting | Boa Vista | Roraima | Brazil |
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| Ee Fagundes Varela | Recruiting | Boa Vista | Roraima | Brazil |
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| Ee Jesus Nazareno de Souza Cruz | Recruiting | Boa Vista | Roraima | Brazil |
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| Em Valdemarina Normando Martins | Recruiting | Boa Vista | Roraima | Brazil |
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| Cem José Aureliano Da Costa | Recruiting | Cantá | Roraima | Brazil |
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| Em Tia Ercília | Recruiting | Cantá | Roraima | Brazil |
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| Cem Maria Mariselma de Oliveira Cruz | Recruiting | Mucajaí | Roraima | Brazil |
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| Ee Vereador Francisco Pereira Lima | Recruiting | Mucajaí | Roraima | Brazil |
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| Em Irmã Leonilde Dal Pós | Recruiting | Mucajaí | Roraima | Brazil |
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| Em Jesus de Nazaré | Recruiting | Mucajaí | Roraima | Brazil |
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| ID | Term |
|---|---|
| D000072758 | Vaccination Refusal |
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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