Vaccine Hesitancy, Vaccine Refusal
Conditions
Keywords
vaccination coverage, HPV vaccine, stepped-wedge design, students
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 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
BEHAVIORALActive 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
BEHAVIORALActive Students Education
Students receive active vaccinations and health education over two months.
BEHAVIORALBasic Health Unit Active Orientation
Nurses from basic health units will conduct an active orientation session at schools about vaccination for students.
OTHERUsual care
No project interventions will be carried out.
Sponsors
Ministry of Health, Brazil
Hospital Israelita Albert Einstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Stepped-wedge, Cluster, and Randomized trial
Eligibility
Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 teachers with complete HPV vaccination (two doses) | 12 months | Rate of complete HPV vaccination scheme (two doses) among teachers |
| Proportion of vaccination refusal among children and adolescents | 12 months | Rate of HPV vaccination refusal |
| Proportion of vaccination refusal among teachers | 12 months | Rate of teacher HPV vaccination refusal |
Countries
Brazil
Contacts
Primary ContactSoraya S Cruz
Backup ContactHenrique A Fonseca
Outcome results
None listed