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Идёт набор NCT06513494

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

Без фазы С лечением Vaccine Refusal Vaccine Hesitancy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Active Students Education plus Teacher Training, Active Students Education, Basic Health Unit Active Orientation, Usual care.
Кому может быть актуально
Состояния в реестре: Vaccine Refusal, Vaccine Hesitancy. Базовые параметры: 9 лет — 14 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

  • Поведенческое 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
  • Поведенческое Active Students Education
    Students receive active vaccinations and health education over two months.
  • Поведенческое Basic Health Unit Active Orientation
    Nurses from basic health units will conduct an active orientation session at schools about vaccination for students.
  • Другое Usual care
    No project interventions will be carried out.

Первичные конечные точки

  • Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention [Срок оценки: 12 months]
Вторичные конечные точки (4)
  • Proportion of children and adolescents with complete HPV vaccination [Срок оценки: 12 months]
  • Proportion of teachers with complete HPV vaccination (two doses) [Срок оценки: 12 months]
  • Proportion of vaccination refusal among children and adolescents [Срок оценки: 12 months]
  • Proportion of vaccination refusal among teachers [Срок оценки: 12 months]

Критерии участия

Criteria for students

Критерии включения

  • Students of both sexes aged 9 to 14 years old.

Критерии исключения

  • Students with a complete HPV vaccination (two doses) received.

Criteria for Clusters

Критерии включения

  • The school has enrolled students aged 9 to 14 years old.

Критерии исключения

  • Schools that do not have students aged between 9 and 14;
  • Schools that provided only distance education

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Бразилия · 79 центров
  • 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
  • … и ещё 71 центр

Идентификаторы

NCT: NCT06513494 · EDUCAVAC trial

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗