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NCT Number: NCT06513494

Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial

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.

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Key information

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cel Filemon Fernandes Teles, Crato, Ceará, Brazil

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Students Education plus Teacher Training

Behavioral

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 Education

Behavioral

Students receive active vaccinations and health education over two months.

Basic Health Unit Active Orientation

Behavioral

Nurses from basic health units will conduct an active orientation session at schools about vaccination for students.

Usual Care

Other

No project interventions will be carried out.

Primary outcomes

  1. 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

Secondary outcomes

  1. Proportion of children and adolescents with complete HPV vaccination

    Time frame: 12 months

    Rate of complete HPV vaccination scheme (two doses) among childrens and adolescents

  2. Proportion of teachers with complete HPV vaccination (two doses)

    Time frame: 12 months

    Rate of complete HPV vaccination scheme (two doses) among teachers

  3. Proportion of vaccination refusal among children and adolescents

    Time frame: 12 months

    Rate of HPV vaccination refusal

  4. Proportion of vaccination refusal among teachers

    Time frame: 12 months

    Rate of teacher HPV vaccination refusal

Study contacts

Contact information is provided by the study sponsor or research team.

Henrique A Fonseca

CONTACT

[email protected]

55 11 2151-1233

Soraya S Cruz

CONTACT

[email protected]

55 11 2151-1233 ext. ARO

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

A Stepped-wedge, Cluster, and Randomized Trial to Evaluate Active Health Education Methods to Increase Human Papillomavirus Vaccine Coverage in Youth

Acronym: EDUCAVAC

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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