Active health education to increase HPV vaccine coverage in schoolchildren
Official title: A Stepped-wedge, Cluster, and Randomized Trial to Evaluate Active Health Education Methods to Increase Human Papillomavirus Vaccine Coverage in Youth
Run by Hospital Israelita Albert Einstein · NCT06513494 · Data updated 2026-11-12
This project will try different active health-education approaches in schools to see if they increase HPV vaccination among 9–14-year-old students in Brazil.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 9 Years to 14 Years |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Hospital Israelita Albert Einstein Academic / other |
| Locations | 79 sites (Crato, Ceará and 78 other locations) |
| Status | Recruiting |
| Started | March 24, 2025 |
| Main results expected | December 1, 2025 |
| Study ends | December 1, 2026 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT06513494 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are students aged 9 to 14 years who have not yet completed the HPV vaccination series and who attend a participating school in Brazil.
✕Probably not a fit
Students who have already received the full two-dose HPV vaccination series, or those not enrolled at participating schools, are unlikely to benefit from the interventions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial uses a stepped-wedge, cluster-randomized design in which school clusters cross over to interventions every two months. Four approaches are compared: student education plus teacher training with Basic Health Unit activities, student education with Basic Health Unit activities, Basic Health Unit activities alone, and usual care. About 5,000 students in roughly two hundred schools across Brazil are enrolled and schools are randomized in clusters. Outcomes focus on HPV vaccine uptake (completion of recommended doses) following the interventions.
Why it matters
Potential benefit: If successful, the interventions could substantially increase HPV vaccine uptake among school-aged children and reduce future HPV-related disease.
How similar studies have gone: Previous work using reminders and messaging has increased vaccination coverage, but direct active health-education approaches in school populations have less robust, mixed evidence.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Cel Filemon Fernandes Teles
Crato, Ceará, Brazil Recruiting -
Dom Vicente de Paula Araujo Matos
Crato, Ceará, Brazil Recruiting -
EEIEF Maria Yara de Brito Gonçalves CAIC
Crato, Ceará, Brazil Recruiting -
EEIF Antonio Antuérpio Gonzaga de Melo
Crato, Ceará, Brazil Recruiting -
EEF José Ferreira Menezes
Juazeiro do Norte, Ceará, Brazil Recruiting -
EEF Raimundo Pessoa
Juazeiro do Norte, Ceará, Brazil Recruiting
Show 44 more locations
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EEF Zila Belem
Juazeiro do Norte, Ceará, Brazil Recruiting -
Emef Mário Da Silva Bem
Juazeiro do Norte, Ceará, Brazil Recruiting -
Emef Professora Maria de Lourdes Lopes de Sousa
Juazeiro do Norte, Ceará, Brazil Recruiting -
EMEIF Maria Do Socorro Cardoso
Juazeiro do Norte, Ceará, Brazil Recruiting -
CED 4 do Guará
Brasília, Federal District, Brazil Recruiting -
CEF 04 Ceilandia
Brasília, Federal District, Brazil Recruiting -
CEF 2 da estrutural
Brasília, Federal District, Brazil Recruiting -
CEF 3 da Estrutural
Brasília, Federal District, Brazil Recruiting -
CEF 4 Guará
Brasília, Federal District, Brazil Recruiting -
CEF Lobo Guará
Brasília, Federal District, Brazil Recruiting -
CEF Santos Dumont
Brasília, Federal District, Brazil Recruiting -
CEF Telebrasília
Brasília, Federal District, Brazil Recruiting -
CEF Vargem Bonita
Brasília, Federal District, Brazil Recruiting -
Cei 02 - Prof João Crisóstomo de Figueiredo
Cuiabá, Mato Grosso, Brazil Recruiting -
Ee Ana Maria Do Couto
Cuiabá, Mato Grosso, Brazil Recruiting -
Ee Mariana Luiza Moreira
Cuiabá, Mato Grosso, Brazil Recruiting -
EE PROFª DIVA HUGUENEY DE SIQUEIRA BASTOS
Cuiabá, Mato Grosso, Brazil Recruiting -
EE PROFº RAFAEL RUEDA
Cuiabá, Mato Grosso, Brazil Recruiting -
Ee Deputado Milton Figueiredo
Várzea Grande, Mato Grosso, Brazil Recruiting -
EE Tancredo de Almeida Neves
Couto de Magalhães de Minas, Minas Gerais, Brazil Recruiting -
EM São Judas Tadeu
Couto de Magalhães de Minas, Minas Gerais, Brazil Recruiting -
EE Arthur Tibães
Diamantina, Minas Gerais, Brazil Recruiting -
EE João Cesar de Oliveira
Diamantina, Minas Gerais, Brazil Recruiting -
EE Professor Gabriel Madacaru
Diamantina, Minas Gerais, Brazil Recruiting -
EE Professor Leopoldo Miranda
Diamantina, Minas Gerais, Brazil Recruiting -
EE Professora Gabriela Neves
Diamantina, Minas Gerais, Brazil Recruiting -
Escola Estadual Professora Isabel Motta
Diamantina, Minas Gerais, Brazil Recruiting -
EE Felício dos Santos
Felício dos Santos, Minas Gerais, Brazil Recruiting -
EM Santo Antônio
Felício dos Santos, Minas Gerais, Brazil Recruiting -
EE Dom João Antônio dos Santo
São Gonçalo do Rio Preto, Minas Gerais, Brazil Recruiting -
EM Zulma Rocha dos Santos
São Gonçalo do Rio Preto, Minas Gerais, Brazil Recruiting -
CE C-M-Ef M Profis Jose Elias da Rocha
Ponta Grossa, Paraná, Brazil Recruiting -
CE Pe-Ef M Pedro Grzelczaki
Ponta Grossa, Paraná, Brazil Recruiting -
CE Prof-Ef M Profis Meneleu A Torres
Ponta Grossa, Paraná, Brazil Recruiting -
CE Prof-Ef M Profis. Joao R V B du Vernay
Ponta Grossa, Paraná, Brazil Recruiting -
EE Profa-Ef Halia T Gruba
Ponta Grossa, Paraná, Brazil Recruiting -
EE-Ef Jesus Divino Operario
Ponta Grossa, Paraná, Brazil Recruiting -
EM Doutor Leopoldo Pinto Rosas
Ponta Grossa, Paraná, Brazil Recruiting -
EM Professora Agenoridas Stadler
Ponta Grossa, Paraná, Brazil Recruiting -
EM Professora Cristiane Levandowski
Ponta Grossa, Paraná, Brazil Recruiting -
EM Professora Zair Santos Nascimento
Ponta Grossa, Paraná, Brazil Recruiting -
EM Professora Zanoni Rogoski
Ponta Grossa, Paraná, Brazil Recruiting -
EM Alfredo Monteiro de Seixas
Augusto Corrêa, Pará, Brazil Recruiting -
EM Andre Alves
Augusto Corrêa, Pará, Brazil Recruiting
+29 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Soraya S Cruz
- Email: soraya.cruz@einstein.br
- Phone: 55 11 2151-1233
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.