Clinical trial NCT06048406: Effect of Health Education on Promoting Influenza Vaccination Health Literacy
Official title: Effect of Health Education on Promoting Influenza Vaccination Health Literacy Among Primary School Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaccination; Infection
Influenza
Keywords: health education
health literacy
schools
China
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 3036
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on influenza vaccination rates and health literacy in primary school students in the city of Dongguan in China.

Individuals aged 7 to 12 years who are in grades 4-5 in primary schools in Dongguan will be enrolled. 20 primary schools will be randomly selected, with half designated as intervention group schools and the remaining half as control group schools. The intervention group will receive a monthly health education intervention focused on influenza vaccination for 5 months, while the control group will continue with their routine school health education for 5 months.

Researchers will compare the differences in influenza vaccination rates and influenza vaccination health literacy levels between the intervention and control groups after 5 months to see if health education can promote influenza vaccination health literacy among primary school students.

Detailed description: Introduction: Influenza is a major public health threat, and vaccination is the most effective prevention method. However, vaccination coverage remains suboptimal. Low health literacy regarding influenza vaccination may contribute to vaccine hesitancy. This study aims to evaluate the effect of health education interventions on influenza vaccination rates and health literacy.

Methods and analysis: This cluster randomized controlled trial will enroll 3036 students in grades 4-5 from 20 primary schools in Dongguan City, China. Schools will be randomized to an intervention group receiving influenza vaccination health education or a control group receiving routine health education. The primary outcome is influenza vaccination rate. Secondary outcomes include health literacy levels, influenza diagnosis rate, influenza-like illness incidence, and vaccine protection rate. Data will be collected through questionnaires, influenza surveillance, and self-reports at baseline and study conclusion.

Ethics and dissemination: Ethical approval has been sought from the Ethics Committee of the School of Public Health, Sun Yat-sen University. Findings from the study will be made accessible to both peer-reviewed journals and key stakeholders.

Eligibility criteria: Inclusion Criteria:

* Primary school students within the age range of 7-12 years.
* Students and their parents who voluntarily agree to participate in the study and provide signed informed consent.
* Permanent residents of Dongguan City who are expected to complete the project without transferring schools during the study period.

Exclusion Criteria:

* Individuals with contraindications to influenza vaccination, who have recently received an influenza vaccination, diagnosed with influenza or confirmed as influenza-like cases at the commencement of the study.
* Unwilling to participate in the project.

Primary outcomes:
measure: influenza vaccination rate
timeFrame: Within 20 weeks from enrollment
Secondary outcomes:
measure: influenza vaccination health literacy level
timeFrame: Within 20 weeks from enrollment
measure: influenza incidence
timeFrame: Within 20 weeks from enrollment
measure: influenza vaccine protection rate
timeFrame: Within 20 weeks from enrollment
measure: influenza-like illness incidence
timeFrame: Within 20 weeks from enrollment
Other outcomes:
Locations:
city: Dongguang
country: China
facility: Dongguang Center for Disease Control and Prevention
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Lin Xu, PhD
role: PRINCIPAL_INVESTIGATOR
References: