Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial
- Conditions
- Vaccine RefusalVaccine Hesitancy
- Interventions
- Behavioral: Active Students EducationBehavioral: Basic Health Unit Active OrientationBehavioral: Active Students Education plus Teacher TrainingOther: Usual care
- Registration Number
- NCT06513494
- Lead Sponsor
- Hospital Israelita Albert Einstein
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- Students of both sexes aged 9 to 14 years old.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Students Education Active Students Education Clusters will perform active training for only students. Basic Health Unit Active Orientation Basic Health Unit Active Orientation Clusters will receive a nurse-led orientation session on vaccination for students in schools. Active Students Education plus Teacher Training Active Students Education plus Teacher Training Clusters will perform active training for both teachers and students. Usual care Usual care No project interventions will be carried out.
- Primary Outcome Measures
Name Time Method Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention 12 months Rate of HPV vaccination among childrens and adolescents
- Secondary Outcome Measures
Name Time Method Proportion of teachers with complete HPV vaccination (two doses) 12 months Rate of complete HPV vaccination scheme (two doses) among teachers
Proportion of children and adolescents with complete HPV vaccination 12 months Rate of complete HPV vaccination scheme (two doses) among childrens and adolescents
Proportion of vaccination refusal among teachers 12 months Rate of teacher HPV vaccination refusal
Proportion of vaccination refusal among children and adolescents 12 months Rate of HPV vaccination refusal