Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Students Education plus Teacher Training, Active Students Education, Basic Health Unit Active Orientation, Usual care.
- Who it may be relevant to
- Registry conditions: Vaccine Refusal, Vaccine Hesitancy. Basic parameters: 9 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Stepped-wedge, Cluster, and Randomized Trial to Evaluate Active Health Education Methods to Increase Human Papillomavirus Vaccine Coverage in Youth
Overview
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
Interventions
- Behavioral 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 - Behavioral Active Students Education
Students receive active vaccinations and health education over two months. - Behavioral Basic Health Unit Active Orientation
Nurses from basic health units will conduct an active orientation session at schools about vaccination for students. - Other Usual care
No project interventions will be carried out.
Primary outcome measures
- Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention [Time frame: 12 months]
Secondary outcome measures (4)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Brazil · 79 centers
- Cel Filemon Fernandes Teles — Crato
- Dom Vicente de Paula Araujo Matos — Crato
- EEIEF Maria Yara de Brito Gonçalves CAIC — Crato
- EEIF Antonio Antuérpio Gonzaga de Melo — Crato
- EEF José Ferreira Menezes — Juazeiro do Norte
- EEF Raimundo Pessoa — Juazeiro do Norte
- EEF Zila Belem — Juazeiro do Norte
- Emef Mário Da Silva Bem — Juazeiro do Norte
- … and 71 more centers
Identifiers
NCT: NCT06513494 · EDUCAVAC trial