Clinical trial NCT06513494: Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial
Official title: A Stepped-wedge, Cluster, and Randomized Trial to Evaluate Active Health Education Methods to Increase Human Papillomavirus Vaccine Coverage in Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaccine Refusal
Vaccine Hesitancy
Keywords: vaccination coverage
HPV vaccine
stepped-wedge design
students
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2024-07-22
Enrollment: 5000
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-wedge, Cluster, and Randomized trial
Primary purpose: PREVENTION

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 80 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 20 schools.

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of children and adolescents with complete HPV vaccination
timeFrame: 12 months
measure: Proportion of teachers with complete HPV vaccination (two doses)
timeFrame: 12 months
measure: Proportion of vaccination refusal among children and adolescents
timeFrame: 12 months
measure: Proportion of vaccination refusal among teachers
timeFrame: 12 months
Other outcomes:
Locations:
city: Crato
country: Brazil
facility: Cel Filemon Fernandes Teles
state: Ceará
city: Crato
country: Brazil
facility: Dom Vicente de Paula Araujo Matos
state: Ceará
city: Crato
country: Brazil
facility: EEIEF Maria Yara de Brito Gonçalves CAIC
state: Ceará
city: Crato
country: Brazil
facility: EEIF Antonio Antuérpio Gonzaga de Melo
state: Ceará
city: Juazeiro do Norte
country: Brazil
facility: EEF José Ferreira Menezes
state: Ceará
city: Juazeiro do Norte
country: Brazil
facility: EEF Raimundo Pessoa
state: Ceará
city: Juazeiro do Norte
country: Brazil
facility: EEF Zila Belem
state: Ceará
city: Juazeiro do Norte
country: Brazil
facility: Emef Mário Da Silva Bem
state: Ceará
city: Juazeiro do Norte
country: Brazil
facility: Emef Professora Maria de Lourdes Lopes de Sousa
state: Ceará
city: Juazeiro do Norte
country: Brazil
facility: EMEIF Maria Do Socorro Cardoso
state: Ceará
city: Brasília
country: Brazil
facility: CED 4 do Guará
state: Distrito Federal
city: Brasília
country: Brazil
facility: CEF 04 Ceilandia
state: Distrito Federal
city: Brasília
country: Brazil
facility: CEF 2 da estrutural
state: Distrito Federal
city: Brasília
country: Brazil
facility: CEF 3 da Estrutural
state: Distrito Federal
city: Brasília
country: Brazil
facility: CEF 4 Guará
state: Distrito Federal
city: Brasília
country: Brazil
facility: CEF Lobo Guará
state: Distrito Federal
city: Brasília
country: Brazil
facility: CEF Santos Dumont
state: Distrito Federal
city: Brasília
country: Brazil
facility: CEF Telebrasília
state: Distrito Federal
city: Brasília
country: Brazil
facility: CEF Vargem Bonita
state: Distrito Federal
city: Cuiabá
country: Brazil
facility: Cei 02 - Prof João Crisóstomo de Figueiredo
state: Mato Grosso
city: Cuiabá
country: Brazil
facility: Ee Ana Maria Do Couto
state: Mato Grosso
city: Cuiabá
country: Brazil
facility: Ee Mariana Luiza Moreira
state: Mato Grosso
city: Cuiabá
country: Brazil
facility: EE PROFª DIVA HUGUENEY DE SIQUEIRA BASTOS
state: Mato Grosso
city: Cuiabá
country: Brazil
facility: EE PROFº RAFAEL RUEDA
state: Mato Grosso
city: Várzea Grande
country: Brazil
facility: Ee Deputado Milton Figueiredo
state: Mato Grosso
city: Couto de Magalhães de Minas
country: Brazil
facility: EE Tancredo de Almeida Neves
state: Minas Gerais
city: Couto de Magalhães de Minas
country: Brazil
facility: EM São Judas Tadeu
state: Minas Gerais
city: Diamantina
country: Brazil
facility: EE Arthur Tibães
state: Minas Gerais
city: Diamantina
country: Brazil
facility: EE João Cesar de Oliveira
state: Minas Gerais
city: Diamantina
country: Brazil
facility: EE Professor Gabriel Madacaru
state: Minas Gerais
city: Diamantina
country: Brazil
facility: EE Professor Leopoldo Miranda
state: Minas Gerais
city: Diamantina
country: Brazil
facility: EE Professora Gabriela Neves
state: Minas Gerais
city: Diamantina
country: Brazil
facility: Escola Estadual Professora Isabel Motta
state: Minas Gerais
city: Felício dos Santos
country: Brazil
facility: EE Felício dos Santos
state: Minas Gerais
city: Felício dos Santos
country: Brazil
facility: EM Santo Antônio
state: Minas Gerais
city: São Gonçalo do Rio Preto
country: Brazil
facility: EE Dom João Antônio dos Santo
state: Minas Gerais
city: São Gonçalo do Rio Preto
country: Brazil
facility: EM Zulma Rocha dos Santos
state: Minas Gerais
city: Ponta Grossa
country: Brazil
facility: CE C-M-Ef M Profis Jose Elias da Rocha
state: Paraná
city: Ponta Grossa
country: Brazil
facility: CE Pe-Ef M Pedro Grzelczaki
state: Paraná
city: Ponta Grossa
country: Brazil
facility: CE Prof-Ef M Profis Meneleu A Torres
state: Paraná
city: Ponta Grossa
country: Brazil
facility: CE Prof-Ef M Profis. Joao R V B du Vernay
state: Paraná
city: Ponta Grossa
country: Brazil
facility: EE Profa-Ef Halia T Gruba
state: Paraná
city: Ponta Grossa
country: Brazil
facility: EE-Ef Jesus Divino Operario
state: Paraná
city: Ponta Grossa
country: Brazil
facility: EM Doutor Leopoldo Pinto Rosas
state: Paraná
city: Ponta Grossa
country: Brazil
facility: EM Professora Agenoridas Stadler
state: Paraná
city: Ponta Grossa
country: Brazil
facility: EM Professora Cristiane Levandowski
state: Paraná
city: Ponta Grossa
country: Brazil
facility: EM Professora Zair Santos Nascimento
state: Paraná
city: Ponta Grossa
country: Brazil
facility: EM Professora Zanoni Rogoski
state: Paraná
city: Augusto Correa
country: Brazil
facility: EM Alfredo Monteiro de Seixas
state: Pará
city: Augusto Correa
country: Brazil
facility: EM Andre Alves
state: Pará
city: Augusto Correa
country: Brazil
facility: EM Carmem Dilce
state: Pará
city: Augusto Correa
country: Brazil
facility: EM Manoel Sady
state: Pará
city: Augusto Correa
country: Brazil
facility: EM Maria Benedita Mota
state: Pará
city: Augusto Correa
country: Brazil
facility: EM Maria da Conceição Santana
state: Pará
city: Augusto Correa
country: Brazil
facility: EM Rosa Athayde
state: Pará
city: Tracuateua
country: Brazil
facility: EM Edom do Nascimento Pinheiro
state: Pará
city: Tracuateua
country: Brazil
facility: EM Elias Ferez Gorayeb
state: Pará
city: Tracuateua
country: Brazil
facility: EM Levina de Oliveira Reis
state: Pará
city: Tracuateua
country: Brazil
facility: EM Valdemar Pinheiro da Silva
state: Pará
city: Tracuateua
country: Brazil
facility: EM Zulmira Guedes
state: Pará
city: Natal
country: Brazil
facility: EE Alceu Amoroso Lima
state: Rio Grande do Norte
city: Natal
country: Brazil
facility: EE Aldo Fernandes
state: Rio Grande do Norte
city: Natal
country: Brazil
facility: EE Djalma Aranha Marinho
state: Rio Grande do Norte
city: Natal
country: Brazil
facility: EE Isabel Gondim
state: Rio Grande do Norte
city: Natal
country: Brazil
facility: EE Reginaldo Ferreira Neto
state: Rio Grande do Norte
city: Natal
country: Brazil
facility: EM Ferreira Itajubá
state: Rio Grande do Norte
city: Natal
country: Brazil
facility: EM José Alves Landim
state: Rio Grande do Norte
city: Natal
country: Brazil
facility: EM José do Patrocínio Pereira Pinto
state: Rio Grande do Norte
city: Natal
country: Brazil
facility: EM Professora Lourdes Godeiro
state: Rio Grande do Norte
city: Boa Vista
country: Brazil
facility: Cem Iii Irmã Maria Teresa Parodi
state: Roraima
city: Boa Vista
country: Brazil
facility: Ee Fagundes Varela
state: Roraima
city: Boa Vista
country: Brazil
facility: Ee Jesus Nazareno de Souza Cruz
state: Roraima
city: Boa Vista
country: Brazil
facility: Em Valdemarina Normando Martins
state: Roraima
city: Cantá
country: Brazil
facility: Cem José Aureliano Da Costa
state: Roraima
city: Cantá
country: Brazil
facility: Em Tia Ercília
state: Roraima
city: Mucajaí
country: Brazil
facility: Cem Maria Mariselma de Oliveira Cruz
state: Roraima
city: Mucajaí
country: Brazil
facility: Ee Vereador Francisco Pereira Lima
state: Roraima
city: Mucajaí
country: Brazil
facility: Em Irmã Leonilde Dal Pós
state: Roraima
city: Mucajaí
country: Brazil
facility: Em Jesus de Nazaré
state: Roraima
Study officials:
affiliation: Academic Research Organization - Hospital Israelita Albert Einstein
name: Henrique A Fonseca, PhD
role: STUDY_CHAIR
affiliation: Academic Research Organization - Hospital Israelita Albert Einstein
name: Luiz V Rizzo, PhD
role: STUDY_DIRECTOR
References: