Vaccine RefusalEDUCAVACNCT06513494
Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial
A study testing Active Students Education plus Teacher Training, Active Students Education and Basic Health Unit Active Orientation in people with Vaccine Refusal and Vaccine Hesitancy, run by Hospital Israelita Albert Einstein at 79 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Refusal, Vaccine Hesitancy
- What is being tested?
- Active Students Education plus Teacher Training, Active Students Education and Basic Health Unit Active Orientation
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 79 sitesBrazil
- Study dates
- 24 Mar 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students of both sexes aged 9 to 14 years old.
- The school has enrolled students aged 9 to 14 years old.
Who cannot join
- Students with a complete HPV vaccination (two doses) received.
- Criteria for Clusters
- Schools that do not have students aged between 9 and 14;
- Schools that provided only distance education
Trial locations and contacts
79 sites in 1 country. Contact the study team or a site near you to ask about taking part.
79 sites in 1 country
Brazil79 sites, 79 recruiting
- Recruiting
EM Alfredo Monteiro de Seixas
Augusto Corrêa, Pará
Lucinaldo S Blandtt, BSc, +55 91 992006535, blandtt.naldo@gmail.com
- Recruiting
EM Andre Alves
Augusto Corrêa, Pará
Lucinaldo S Blandtt, BSc, +55 91 992006535, blandtt.naldo@gmail.com
- Recruiting
EM Carmem Dilce
Augusto Corrêa, Pará
Lucinaldo S Blandtt, BSc, +55 91 992006535, blandtt.naldo@gmail.com
- Recruiting
EM Manoel Sady
Augusto Corrêa, Pará
Lucinaldo S Blandtt, BSc, +55 91 992006535, blandtt.naldo@gmail.com
- Recruiting
EM Maria Benedita Mota
Augusto Corrêa, Pará
Lucinaldo S Blandtt, BSc, +55 91 992006535, blandtt.naldo@gmail.com
- Recruiting
EM Maria da Conceição Santana
Augusto Corrêa, Pará
Lucinaldo S Blandtt, BSc, +55 91 992006535, blandtt.naldo@gmail.com
- Recruiting
EM Rosa Athayde
Augusto Corrêa, Pará
Lucinaldo S Blandtt, BSc, +55 91 992006535, blandtt.naldo@gmail.com
- Recruiting
Cem Iii Irmã Maria Teresa Parodi
Boa Vista, Roraima
Marcos A A Lima, BSc, +55 95 991445480, marcos2rr@gmail.com
- Recruiting
Ee Fagundes Varela
Boa Vista, Roraima
Marcos A A Lima, BSc, +55 95 991445480, marcos2rr@gmail.com
- Recruiting
Ee Jesus Nazareno de Souza Cruz
Boa Vista, Roraima
Marcos A A Lima, BSc, +55 95 991445480, marcos2rr@gmail.com
- Recruiting
Em Valdemarina Normando Martins
Boa Vista, Roraima
Marcos A A Lima, BSc, +55 95 991445480, marcos2rr@gmail.com
- Recruiting
CED 4 do Guará
Brasília, Federal District
Maria C O Figueiredo, BSc, +55 61 994508218, mariaclarafigueiredo2491@gmail.com
- Recruiting
CEF 04 Ceilandia
Brasília, Federal District
Maria C O Figueiredo, BSc, +55 61 994508218, mariaclarafigueiredo2491@gmail.com
- Recruiting
CEF 2 da estrutural
Brasília, Federal District
Maria C O Figueiredo, BSc, +55 61 994508218, mariaclarafigueiredo2491@gmail.com
- Recruiting
CEF 3 da Estrutural
Brasília, Federal District
Maria C O Figueiredo, BSc, +55 61 994508218, mariaclarafigueiredo2491@gmail.com
- Recruiting
CEF 4 Guará
Brasília, Federal District
Maria C O Figueiredo, BSc, +55 61 994508218, mariaclarafigueiredo2491@gmail.com
- Recruiting
CEF Lobo Guará
Brasília, Federal District
Maria C O Figueiredo, BSc, +55 61 994508218, mariaclarafigueiredo2491@gmail.com
- Recruiting
CEF Santos Dumont
Brasília, Federal District
Maria C O Figueiredo, BSc, +55 61 994508218, mariaclarafigueiredo2491@gmail.com
- Recruiting
CEF Telebrasília
Brasília, Federal District
Maria C O Figueiredo, BSc, +55 61 994508218, mariaclarafigueiredo2491@gmail.com
- Recruiting
CEF Vargem Bonita
Brasília, Federal District
Maria C O Figueiredo, BSc, +55 61 994508218, mariaclarafigueiredo2491@gmail.com
- Recruiting
Cem José Aureliano Da Costa
Cantá, Roraima
Marcos A A Lima, BSc, +55 95 991445480, marcos2rr@gmail.com
- Recruiting
Em Tia Ercília
Cantá, Roraima
Marcos A A Lima, BSc, +55 95 991445480, marcos2rr@gmail.com
- Recruiting
EE Tancredo de Almeida Neves
Couto de Magalhães de Minas, Minas Gerais
Paula M M G Corrêa, BSc, +55 38 999794395, paulinhamunnoguimaraes@gmail.com
- Recruiting
EM São Judas Tadeu
Couto de Magalhães de Minas, Minas Gerais
Paula M M G Corrêa, BSc, +55 38 999794395, paulinhamunnoguimaraes@gmail.com
- Recruiting
Cel Filemon Fernandes Teles
Crato, Ceará
Christian B Silva, BSc, +55 88 999855250, bezerra.chris@gmail.com
- Recruiting
Dom Vicente de Paula Araujo Matos
Crato, Ceará
Christian B Silva, BSc, +55 88 999855250, bezerra.chris@gmail.com
- Recruiting
EEIEF Maria Yara de Brito Gonçalves CAIC
Crato, Ceará
Christian B Silva, BSc, +55 88 999855250, bezerra.chris@gmail.com
- Recruiting
EEIF Antonio Antuérpio Gonzaga de Melo
Crato, Ceará
Christian B Silva, BSc, +55 88 999855250, bezerra.chris@gmail.com
- Recruiting
Cei 02 - Prof João Crisóstomo de Figueiredo
Cuiabá, Mato Grosso
Marta N S Medeiros, BSc, +55 65 992564577, martaneres13@gmail.com
- Recruiting
Ee Ana Maria Do Couto
Cuiabá, Mato Grosso
Marta N S Medeiros, BSc, +55 65 992564577, martaneres13@gmail.com
- Recruiting
Ee Mariana Luiza Moreira
Cuiabá, Mato Grosso
Marta N S Medeiros, BSc, +55 65 992564577, martaneres13@gmail.com
- Recruiting
EE PROFª DIVA HUGUENEY DE SIQUEIRA BASTOS
Cuiabá, Mato Grosso
Marta N S Medeiros, BSc, +55 65 992564577, martaneres13@gmail.com
- Recruiting
EE PROFº RAFAEL RUEDA
Cuiabá, Mato Grosso
Marta N S Medeiros, BSc, +55 65 992564577, martaneres13@gmail.com
- Recruiting
EE Arthur Tibães
Diamantina, Minas Gerais
Paula M M G Corrêa, BSc, +55 38 999794395, paulinhamunnoguimaraes@gmail.com
- Recruiting
EE João Cesar de Oliveira
Diamantina, Minas Gerais
Paula M M G Corrêa, BSc, +55 38 999794395, paulinhamunnoguimaraes@gmail.com
- Recruiting
EE Professor Gabriel Madacaru
Diamantina, Minas Gerais
Paula M M G Corrêa, BSc, +55 38 999794395, paulinhamunnoguimaraes@gmail.com
- Recruiting
EE Professor Leopoldo Miranda
Diamantina, Minas Gerais
Paula M M G Corrêa, BSc, +55 38 999794395, paulinhamunnoguimaraes@gmail.com
- Recruiting
EE Professora Gabriela Neves
Diamantina, Minas Gerais
Paula M M G Corrêa, BSc, +55 38 999794395, paulinhamunnoguimaraes@gmail.com
- Recruiting
Escola Estadual Professora Isabel Motta
Diamantina, Minas Gerais
Paula M M G Corrêa, BSc, +55 38 999794395, paulinhamunnoguimaraes@gmail.com
- Recruiting
EE Felício dos Santos
Felício dos Santos, Minas Gerais
Paula M M G Corrêa, BSc, +55 38 999794395, paulinhamunnoguimaraes@gmail.com
- Recruiting
EM Santo Antônio
Felício dos Santos, Minas Gerais
Paula M M G Corrêa, BSc, +55 38 999794395, paulinhamunnoguimaraes@gmail.com
- Recruiting
EEF José Ferreira Menezes
Juazeiro do Norte, Ceará
Christian B Silva, BSc, +55 88 999855250, bezerra.chris@gmail.com
- Recruiting
EEF Raimundo Pessoa
Juazeiro do Norte, Ceará
Christian B Silva, BSc, +55 88 999855250, bezerra.chris@gmail.com
- Recruiting
EEF Zila Belem
Juazeiro do Norte, Ceará
Christian B Silva, BSc, +55 88 999855250, bezerra.chris@gmail.com
- Recruiting
Emef Mário Da Silva Bem
Juazeiro do Norte, Ceará
Christian B Silva, BSc, +55 88 999855250, bezerra.chris@gmail.com
- Recruiting
Emef Professora Maria de Lourdes Lopes de Sousa
Juazeiro do Norte, Ceará
Christian B Silva, BSc, +55 88 999855250, bezerra.chris@gmail.com
- Recruiting
EMEIF Maria Do Socorro Cardoso
Juazeiro do Norte, Ceará
Christian B Silva, BSc, +55 88 999855250, bezerra.chris@gmail.com
- Recruiting
Cem Maria Mariselma de Oliveira Cruz
Mucajaí, Roraima
Marcos A A Lima, BSc, +55 95 991445480, marcos2rr@gmail.com
- Recruiting
Ee Vereador Francisco Pereira Lima
Mucajaí, Roraima
Marcos A A Lima, BSc, +55 95 991445480, marcos2rr@gmail.com
- Recruiting
Em Irmã Leonilde Dal Pós
Mucajaí, Roraima
Marcos A A +55 95 991445480, BSc, marcos2rr@gmail.com
- Recruiting
Em Jesus de Nazaré
Mucajaí, Roraima
Marcos A A Lima, BSc, +55 95 991445480, marcos2rr@gmail.com
- Recruiting
EE Alceu Amoroso Lima
Natal, Rio Grande do Norte
Nayara C Costa, BSc, +55 84 994444998, nayaracarvalho.costa@gmail.com
- Recruiting
EE Aldo Fernandes
Natal, Rio Grande do Norte
Nayara C Costa, BSc, +55 84 994444998, nayaracarvalho.costa@gmail.com
- Recruiting
EE Djalma Aranha Marinho
Natal, Rio Grande do Norte
Nayara C Costa, BSc, +55 84 994444998, nayaracarvalho.costa@gmail.com
- Recruiting
EE Isabel Gondim
Natal, Rio Grande do Norte
Nayara C Costa, BSc, +55 84 994444998, nayaracarvalho.costa@gmail.com
- Recruiting
EE Reginaldo Ferreira Neto
Natal, Rio Grande do Norte
Nayara C Costa, BSc, +55 84 994444998, nayaracarvalho.costa@gmail.com
- Recruiting
EM Ferreira Itajubá
Natal, Rio Grande do Norte
Nayara C Costa, BSc, +55 84 994444998, nayaracarvalho.costa@gmail.com
- Recruiting
EM José Alves Landim
Natal, Rio Grande do Norte
Nayara C Costa, BSc, +55 84 994444998, nayaracarvalho.costa@gmail.com
- Recruiting
EM José do Patrocínio Pereira Pinto
Natal, Rio Grande do Norte
Nayara C Costa, BSc, +55 84 994444998, nayaracarvalho.costa@gmail.com
- Recruiting
EM Professora Lourdes Godeiro
Natal, Rio Grande do Norte
Nayara C Costa, BSc, +55 84 994444998, nayaracarvalho.costa@gmail.com
- Recruiting
CE C-M-Ef M Profis Jose Elias da Rocha
Ponta Grossa, Paraná
Rodolfo A Dellagrana, BSc, +55 42 984040300, radellagrana@gmail.com
- Recruiting
CE Pe-Ef M Pedro Grzelczaki
Ponta Grossa, Paraná
Rodolfo A Dellagrana, BSc, +55 42 984040300, radellagrana@gmail.com
- Recruiting
CE Prof-Ef M Profis Meneleu A Torres
Ponta Grossa, Paraná
Rodolfo A Dellagrana, BSc, +55 42 984040300, radellagrana@gmail.com
- Recruiting
CE Prof-Ef M Profis. Joao R V B du Vernay
Ponta Grossa, Paraná
Rodolfo A Dellagrana, BSc, +55 42 984040300, radellagrana@gmail.com
- Recruiting
EE Profa-Ef Halia T Gruba
Ponta Grossa, Paraná
Rodolfo A Dellagrana, BSc, +55 42 984040300, radellagrana@gmail.com
- Recruiting
EE-Ef Jesus Divino Operario
Ponta Grossa, Paraná
Rodolfo A Dellagrana, BSc, +55 42 984040300, radellagrana@gmail.com
- Recruiting
EM Doutor Leopoldo Pinto Rosas
Ponta Grossa, Paraná
Rodolfo A Dellagrana, BSc, +55 42 984040300, radellagrana@gmail.com
- Recruiting
EM Professora Agenoridas Stadler
Ponta Grossa, Paraná
Rodolfo A Dellagrana, BSc, +55 42 984040300, radellagrana@gmail.com
- Recruiting
EM Professora Cristiane Levandowski
Ponta Grossa, Paraná
Rodolfo A Dellagrana, BSc, +55 42 984040300, radellagrana@gmail.com
- Recruiting
EM Professora Zair Santos Nascimento
Ponta Grossa, Paraná
Rodolfo A Dellagrana, BSc, +55 42 984040300, radellagrana@gmail.com
- Recruiting
EM Professora Zanoni Rogoski
Ponta Grossa, Paraná
Rodolfo A Dellagrana, BSc, +55 42 984040300, radellagrana@gmail.com
- Recruiting
EE Dom João Antônio dos Santo
São Gonçalo do Rio Preto, Minas Gerais
Paula M M G Corrêa, BSc, +55 38 999794395, paulinhamunnoguimaraes@gmail.com
- Recruiting
EM Zulma Rocha dos Santos
São Gonçalo do Rio Preto, Minas Gerais
Paula M M G Corrêa, BSc, +55 38 999794395, paulinhamunnoguimaraes@gmail.com
- Recruiting
EM Edom do Nascimento Pinheiro
Tracuateua, Pará
Lucinaldo S Blandtt, BSc, +55 91 992006535, blandtt.naldo@gmail.com
- Recruiting
EM Elias Ferez Gorayeb
Tracuateua, Pará
Lucinaldo S Blandtt, BSc, +55 91 992006535, blandtt.naldo@gmail.com
- Recruiting
EM Levina de Oliveira Reis
Tracuateua, Pará
Lucinaldo S Blandtt, BSc, +55 91 992006535, blandtt.naldo@gmail.com
- Recruiting
EM Valdemar Pinheiro da Silva
Tracuateua, Pará
Lucinaldo S Blandtt, BSc, +55 91 992006535, blandtt.naldo@gmail.com
- Recruiting
EM Zulmira Guedes
Tracuateua, Pará
Lucinaldo S Blandtt, BSc, +55 91 992006535, blandtt.naldo@gmail.com
- Recruiting
Ee Deputado Milton Figueiredo
Várzea Grande, Mato Grosso
Marta N S Medeiros, BSc, +55 65 992564577, martaneres13@gmail.com
About this study
Official title: 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.
Read the 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
- Conditions
- Vaccine Refusal, Vaccine Hesitancy
- Being tested
- Active Students Education plus Teacher Training, Active Students Education, Basic Health Unit Active Orientation, Usual care
- Keywords
- vaccination coverage, HPV vaccine, stepped-wedge design, students
- Medical subject headings
- Vaccination Refusal, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Students Education plus Teacher TrainingBehavioural
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 EducationBehavioural
Students receive active vaccinations and health education over two months.
Basic Health Unit Active OrientationBehavioural
Nurses from basic health units will conduct an active orientation session at schools about vaccination for students.
Usual careOther
No project interventions will be carried out.
| Study group | Role | What they receive |
|---|---|---|
| Active Students Education plus Teacher Training | Experimental | Clusters will perform active training for both teachers and students. Receives: Behavioral: Active Students Education plus Teacher Training |
| Active Students Education | Experimental | Clusters will perform active training for only students. Receives: Behavioral: Active Students Education |
| Basic Health Unit Active Orientation | Experimental | Clusters will receive a nurse-led orientation session on vaccination for students in schools. Receives: Behavioral: Basic Health Unit Active Orientation |
| Usual care | Other | No project interventions will be carried out. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention
Rate of HPV vaccination among childrens and adolescents
Measured: 12 months
Secondary outcomes (4)
Proportion of children and adolescents with complete HPV vaccination
Rate of complete HPV vaccination scheme (two doses) among childrens and adolescents
Measured: 12 months
Proportion of teachers with complete HPV vaccination (two doses)
Rate of complete HPV vaccination scheme (two doses) among teachers
Measured: 12 months
Proportion of vaccination refusal among children and adolescents
Rate of HPV vaccination refusal
Measured: 12 months
Proportion of vaccination refusal among teachers
Rate of teacher HPV vaccination refusal
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start24 Mar 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine RefusalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-wedge, Cluster, and Randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor
- Investigators
- Prof. Henrique A Fonseca, PhD, Study chair, Academic Research Organization - Hospital Israelita Albert EinsteinProf. Luiz V Rizzo, PhD, Study chair, Academic Research Organization - Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513494
- Sponsor's protocol ID
- EDUCAVAC trial
- Acronym
- EDUCAVAC
- Status last verified
- Mar 2025
- First submitted
- 16 Jul 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stepped-wedge, Cluster, and Randomized Trial to Evaluate Active Health Education Methods to Increase Human Papillomavirus Vaccine Coverage in Youth
- ClinicalTrials.gov ID
- NCT06513494
- Acronym / sponsor ID
- EDUCAVAC / EDUCAVAC trial
- Conditions
- Vaccine Refusal, Vaccine Hesitancy
- Keywords
- vaccination coverage, HPV vaccine, stepped-wedge design, students
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Stepped-wedge, Cluster, and Randomized trial
| Arm | Type | Receives |
|---|---|---|
| Active Students Education plus Teacher Training | Experimental | Behavioral: Active Students Education plus Teacher TrainingClusters will perform active training for both teachers and students. |
| Active Students Education | Experimental | Behavioral: Active Students EducationClusters will perform active training for only students. |
| Basic Health Unit Active Orientation | Experimental | Behavioral: Basic Health Unit Active OrientationClusters will receive a nurse-led orientation session on vaccination for students in schools. |
| Usual care | Other | Other: Usual careNo project interventions will be carried out. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Students of both sexes aged 9 to 14 years old.
- The school has enrolled students aged 9 to 14 years old.
Key exclusion criteria (4 listed)
- Students with a complete HPV vaccination (two doses) received.
- Criteria for Clusters
- Schools that do not have students aged between 9 and 14;
- Schools that provided only distance education
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Students Education plus Teacher TrainingThe 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 | Behavioural | Active Students Education plus Teacher Training |
| Active Students EducationStudents receive active vaccinations and health education over two months. | Behavioural | Active Students Education |
| Basic Health Unit Active OrientationNurses from basic health units will conduct an active orientation session at schools about vaccination for students. | Behavioural | Basic Health Unit Active Orientation |
| Usual careNo project interventions will be carried out. | Other | Usual care |
Primary outcome
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
4 secondary outcomes
Proportion of children and adolescents with complete HPV vaccination
Time frame: 12 months
Proportion of teachers with complete HPV vaccination (two doses)
Time frame: 12 months
Proportion of vaccination refusal among children and adolescents
Time frame: 12 months
Proportion of vaccination refusal among teachers
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Henrique A Fonseca, PhD study chair
Academic Research Organization - Hospital Israelita Albert Einstein
Prof. Luiz V Rizzo, PhD study chair
Academic Research Organization - Hospital Israelita Albert Einstein
79 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Students Education plus Teacher Training, Active Students Education and Basic Health Unit Active Orientation in people with Vaccine Refusal and Vaccine Hesitancy, run by Hospital Israelita Albert Einstein at 79 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soraya S Cruz (55 11 2151-1233 ext. ARO, soraya.cruz@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.