Article Text

Protocol
Impact of health education on promoting influenza vaccination health literacy in primary school students: a cluster randomised controlled trial protocol
  1. Weiguang Xie1,
  2. Jingyi Xiao2,
  3. Jingyi Chen2,
  4. Anzhong Huang1,
  5. Xuehua Huang1,
  6. Shaoyi He2,
  7. Lin Xu2
  1. 1Center for Disease Control and Prevention of Dongguan City, Dongguan, Guangdong Province, China
  2. 2Sun Yat-Sen University, Guangzhou, China
  1. Correspondence to Professor Lin Xu; xulin27{at}mail.sysu.edu.cn

Abstract

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 randomised controlled trial will enrol 3036 students in grades 4–5 from 20 primary schools in Dongguan City, China. Schools will be randomised to an intervention group receiving influenza vaccination health education or a control group receiving routine health education. The primary outcome is the 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.

Trial registration number NCT06048406.

  • Health Education
  • Health Literacy
  • Schools
  • China
  • Randomized Controlled Trial
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STRENGTHS AND LIMITATIONS OF THIS STUDY

  • Uses a robust cluster randomised controlled trial design to minimise bias.

  • Implements a multicomponent health education intervention grounded in theory and evidence.

  • Assesses impact on both behaviour (vaccination) and hypothesised mediating factor (health literacy).

  • Relies on self-reported data for some measures. The unverified questionnaire may compromise the accuracy of health literacy outcomes.

  • Potential for contamination across study arms due to the same communities.

Introduction

The influenza virus, known for its mutability and potent infectivity, poses a significant health risk. Influenza cases are characterised by initial symptoms such as fever, headache, myalgia and general malaise, with body temperatures potentially reaching 39°C–40°C.1 Patients may experience chills, muscle and joint pain, fatigue, loss of appetite, nasal congestion, runny nose, substernal discomfort, facial flushing, and conjunctival hyperaemia.1 Influenza poses a significant health risk, particularly in densely populated settings such as schools, where rapid transmission can lead to widespread outbreaks affecting not only the health of individual students but also educational outcomes due to increased absenteeism and disruptions to learning.2 In vulnerable populations, such as young children, influenza can lead to severe complications, hospitalisations, and in some cases, fatal outcomes, underscoring the critical need for effective preventive measures.3 The influenza vaccine represents the most effective tool we have to mitigate these impacts, offering the potential to significantly reduce the incidence of illness, decrease the burden on healthcare systems and contribute to the maintenance of normal educational activities by keeping children healthy and in school.4

Recent trends indicate an escalating incidence of influenza in China, thereby posing a substantial threat to public health.5 6 According to national influenza surveillance data, each October marks the onset of the winter and spring influenza epidemic seasons across various regions in China.7 8 Currently, the most effective preventative measure against influenza is vaccination.9 Seasonal influenza vaccinations have demonstrated effectiveness in reducing the risk of influenza infection and severe complications across all age groups.10 Seasonal influenza epidemics often precipitate outbreaks in densely populated areas such as schools, childcare institutions and nursing homes.10 However, in China, influenza vaccinations are not typically administered as part of school-based vaccination programmes. Unlike some other vaccines that are included in China’s National Immunisation Programme and can be administered in school settings, influenza vaccines are generally obtained through healthcare facilities outside of the educational system. Parents or guardians are responsible for deciding to vaccinate their children against influenza and must seek out vaccination services from healthcare providers, such as community health centres, hospitals or clinics.

Health literacy, defined as an individual’s capacity to acquire, comprehend and use basic health information and services for informing health decisions, plays a pivotal role in vaccination uptake.11 12 Enhancing vaccine health literacy can potentially augment vaccination willingness and mitigate vaccination hesitancy.13 Increasing vaccination willingness and mitigating hesitancy are pivotal for enhancing community immunity, particularly in school settings where close contact facilitates the rapid spread of influenza.14 A higher willingness to vaccinate leads to increased vaccination rates, which in turn reduces the incidence of influenza, minimising its adverse effects on public health and educational continuity. Moreover, improving the population’s health literacy regarding influenza vaccination—encompassing an understanding of the vaccine’s benefits, safety and the role it plays in preventing illness—can foster positive attitudes and proactive health behaviours.14 This heightened awareness and informed behaviour are crucial for creating a supportive environment for vaccination initiatives, thereby enhancing the overall effectiveness of public health strategies aimed at controlling influenza outbreaks.14 Therefore, improving the population’s vaccine health literacy is integral to the successful implementation of influenza prevention and control measures and strategy development. Parents’ vaccine literacy, encompassing their ability to understand, assess and make informed decisions about vaccinations, plays a crucial role in the immunisation of children against influenza. Studies have shown that higher levels of vaccine literacy among parents are associated with increased vaccination rates in children,15 16 underscoring the importance of addressing parental knowledge and beliefs in vaccination campaigns. However, vaccine hesitancy among parents, often stemming from misinformation and a lack of clear communication, poses a significant barrier to achieving optimal vaccination coverage.11 Therefore, enhancing parents’ vaccine literacy through targeted health education interventions could be a key strategy in improving influenza vaccination rates among primary school students.

While numerous studies have investigated the broader implications of health education interventions on vaccination awareness and rates, there remains a distinct lack of focused research specifically targeting primary school students, especially within the context of China.17–19 The unique age group, characterised by their transitional cognitive abilities and susceptibility to influence, may respond differently to health literacy interventions than other age cohorts. Moreover, regional differences, cultural practices and local health infrastructure in China might further impact the effectiveness of such interventions.20 Thus, this study aims to investigate the influence of health education on influenza vaccination rates and the level of influenza vaccination health literacy among fourth-grade and fifth-grade primary school students. The methodological approach will involve a cluster randomised trial with schools serving as the unit of analysis. The findings will provide a scientific basis for future interventions.

Methods and analysis

This study is supported by the Department of Education of Guangdong Province, which is instrumental in the recruitment of schools through the Dongguan Education Bureau. The recruitment process will be initiated by an official invitation letter from the Department of Education, directed to selected schools within Dongguan City. This letter will formally introduce the aims and its relevance to public health and education, facilitating a trusted partnership between the research team and the schools. The involvement of these educational authorities ensures the study’s legitimacy and aligns the recruitment process with official educational policies and guidelines, which will also ensure high retention rates in our study.

Study objectives

This study seeks to explore the impact of health education interventions on vaccination and influenza vaccination awareness among primary school students. By evaluating the impact of health education on the seasonal influenza vaccination rate and the level of influenza vaccination health literacy, we aim to provide a scientific foundation for regional influenza prevention and control strategies. The specific objectives of this research are as follows: (1) To ascertain the rate of influenza infection, the status of influenza vaccination and the level of vaccine literacy related to influenza vaccination among primary school students in Dongguan City. (2) To compare and contrast the influenza vaccination rate and the level of influenza vaccination health literacy between the experimental and control groups, thereby evaluating the impact of health education intervention on these parameters. (3) To assess the efficacy of influenza vaccine immunisation among primary school students in Dongguan City.

Study design

The proposed study is a cluster randomised controlled trial. Two administrative districts, one in the central urban area and the other in the non-central urban area of Dongguan, will be selected for this study. Within each district, 10 primary schools will be randomly selected, with half designated as intervention group schools and the remaining half as control group schools. This results in a total of 20 primary schools, evenly split between the intervention and control groups.

The intervention group will receive a health education intervention focused on influenza vaccination, while the control group will continue with their routine school health education. The intervention period for this study is projected to last approximately 3–4 months. We will collect data at the onset and conclusion of the intervention period. The primary outcomes of interest are the differences in influenza vaccination rates between the experimental and control groups, which will be used to evaluate the effectiveness of the intervention. The overview of the study procedure is shown in the figure 1.

Figure 1

Overview of the study.

Informed consent

As part of the participant enrolment process, we will adhere to strict ethical guidelines, ensuring that all participants and their guardians are fully informed about the study’s objectives, procedures, potential risks and benefits. Prior to enrolment, comprehensive informed consent will be obtained from the parents or legal guardians of all participating students. This consent process will be conducted in a manner that respects the autonomy of the participants and their families, providing them with all necessary information to make an informed decision about their involvement in the study. The informed consent documents will be designed to be clear and understandable, ensuring that participants’ rights and welfare are protected throughout the study (online supplemental material 1).

Study sample

Study participants will be primary school students in grades 4–5 in Dongguan City.

Inclusion criteria include (1) Primary school students within the age range of 7–12 years. (2) Students and their parents who voluntarily agree to participate in the study and provide signed informed consent. (3) Residents of Dongguan City who are expected to complete the project without transferring schools during the study period.

In addition, 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, or unwilling to participate in the project, will be excluded.

Sampling method

The study employs a multistage cluster sampling method. In the first stage, 1 central urban area (tentatively identified as Dongcheng Street, which oversees 31 primary schools) and 1 non-central urban area (tentatively identified as Gaobu Town, which oversees 13 primary schools) will be randomly selected, reflecting the urban–rural structure of Dongguan City. In the second stage, 10 primary schools will be randomly selected from each administrative district, with 5 designated as intervention group schools and the remaining 5 as control group schools. This results in a total of 20 primary schools, evenly split between the intervention and control groups. In the third stage, 2 classes from each of the 2 grades (fourth and fifth grades) will be randomly selected from each of the 20 selected schools using a cluster sampling method, with surveys conducted at the class level. Each school comprises a minimum of 152 students. Schools with 152 students will have 1 additional class randomly selected. The final estimated total sample size is projected to be 3036. Random sampling and randomised grouping are achieved using computer software to generate random numbers. The sample size is determined using the following formula:

Embedded Image

where: n is the desired sample size for each cohort, Embedded Image is the value corresponding to the accepted type I error rate (eg, Embedded Image about 1.96 for an error rate of 0.05), Embedded Image is the value corresponding to the desired statistical power, for example, for a power of 0.8, Embedded Image is approximately 0.84. m is the size of each cohort, ρ is the intra-group correlation coefficient, Embedded Image is the expected outcome rate in the test group (ie, influenza vaccination rate), and Embedded Image is the expected outcome rate in the control group. Based on the assumption that the anticipated influenza vaccination rate is 80% in the intervention group and 50% in the control group, the estimated sample size, denoted as ‘n’, is 138 students per school.21 22 This implies that approximately 138 primary school students are required for each group, yielding a total sample size of 2760 individuals. To account for potential sample attrition, the sample size is expanded by 10%, resulting in a final estimated total sample size of 3036 for statistical analysis.

Intervention methods

The intervention group will receive a health education intervention focused on influenza vaccination literacy, while the control group will continue with their standard school health education without any additional intervention. An influenza vaccination health education programme will include topics such as the importance of influenza vaccination, the benefits of vaccination and vaccination methods. The programme will be developed and reviewed by an expert group. The package for the intervention group will include educational activities, distribution of promotional materials, vaccination services and distribution of vaccination souvenirs. The details are as follows:

  1. Educational activities include classroom lectures and parent meetings. Medical professionals or public health experts will be invited to deliver lectures at the school, providing detailed information on the role and benefits of influenza vaccination and the risks of influenza. Our health education programme is designed to deliver a total of four lectures at the participating schools, with one lecture scheduled each month over the course of the intervention period, which spans approximately 4 months. This structured approach allows us to provide in-depth, focused content in each session, ensuring that students can absorb and reflect on the information presented. To maintain consistency in the delivery and quality of the health education content, the same team of individuals will present these lectures across all participating schools. This team will comprise medical professionals or public health experts who are not only knowledgeable about influenza and its prevention but are also experienced in engaging with a younger audience. By having the same individuals deliver all lectures, we aim to build a rapport with the students, thereby enhancing the effectiveness of the educational messages and ensuring that the information is presented in a coherent and consistent manner. Each lecture in the series will focus on different aspects of influenza vaccination and health literacy, tailored to be age-appropriate and relevant to the students’ experiences. Topics will include understanding influenza and its impact, the importance of vaccination, how vaccines work and practical advice on health practices to prevent influenza. The lectures will be interactive, incorporating activities, visual aids and question-and-answer sessions to actively involve the students in the learning process. In addition, teachers will discuss the importance of the influenza vaccine at parent meetings, encouraging parents to facilitate their children’s vaccination.

  2. Promotional materials include educational booklet, vaccination service and vaccination souvenirs. Educational booklet will be designed and distributed to students to raise their awareness of influenza vaccines, which is being developed in collaboration with the Center for Disease Control and Prevention of Dongguan City (Dongguan CDC). Influenza vaccination services will be provided to students who have no contraindications to influenza vaccination, are in good health and are at least 4–6 months post their last influenza vaccination, based on the principle of informed consent, voluntariness and self-payment. The stipulation for participants to be at least 4–6 months post their last influenza vaccination is a safety measure to accommodate the study’s enrolment period and should not be interpreted as an indication of biannual vaccination practice. This approach is consistent with the standard practice of annual influenza vaccination recommended by global health guidelines and is intended to synchronise with the seasonal influenza vaccination campaign in China, which typically begins in the autumn. This time frame ensures that the vaccination services are provided at an optimal time for influenza prevention, enhancing the relevance and applicability of the study findings to public health practices. ‘Epidemic Prevention Little Guards’ medals will be created and distributed to vaccinated students as a commemorative incentive to encourage vaccination.

Intervention time

Dongguan CDC staff will visit the school in the first month to implement intervention activities using the health education intervention package. The intervention period will commence in September 2023 and conclude in February 2024, resulting in a total intervention duration of approximately 3–4 months. The specific intervention process will be as follows: (1) At the start of the semester (early intervention stage in September 2023), initiation activities will be conducted. The investigators will introduce the study to teachers and students, and medical professionals or public health experts will be invited to deliver classroom lectures at the intervention group schools. Baseline data will be collected at this stage. (2) During the intervention period (September 2023–January 2024), the intervention group will follow the health education intervention toolkit to conduct intervention activities. (3) At the conclusion of the semester (February 2024), follow-up data will be collected. The intervention timeline is shown in figure 2.

Figure 2

Intervention timeline.

Data collection and analysis

Students and parents will be asked to complete study surveys before and after the intervention, using self-completion. The questionnaire design, which is informed by similar research literature (online supplemental tables 1 and 2), will undergo evaluations for reliability and validity. The questionnaire will include the following content: (1) sociodemographic characteristics (name, age, sex, class, residential address, parents’ educational level, occupation, family income); (2) personal history (basic disease history, allergy history and personal history) and (3) influenza vaccination health literacy level. The health literacy level concerning influenza vaccination will be assessed across four dimensions: knowledge, attitude, behaviour and skills related to influenza vaccination. Details of these four dimensions include knowledge of basic facts about the influenza vaccine (such as its efficacy, vaccination frequency and side effects), attitudes towards the influenza vaccine (including perceptions of its efficacy and safety), behavioural characteristics related to influenza vaccination (such as willingness to be vaccinated, vaccination status and timing of vaccination) and sources of information about the influenza vaccine.

Confirmation of influenza and surveillance of influenza-like cases

Confirmed cases must have one or more of the following positive pathogenic test results: influenza virus nucleic acid test, influenza antigen test, influenza virus culture isolation and a fourfold or greater increase in the level of influenza virus-specific IgG antibody in the convalescent and recovery period double sera compared with the acute stage.

Confirmed cases of influenza will primarily be identified through the municipal CDC influenza surveillance network. Furthermore, influenza-like illness (ILI) is defined as instances of fever (body temperature ≥38°C) accompanied by either a cough or sore throat, with epidemiological evidence or a positive influenza rapid antigen test, and excluding other diseases that cause influenza-like symptoms. The fever should occur within the current acute febrile illness period. Body temperature identification includes self-measurement by patients and temperature detection by medical institutions. Identification of ILI cases can be achieved through the establishment of a case reporting system in schools or student or parent self-report. The case reporting system in schools involves training school medical staff and teachers to understand the definition and reporting methods for ILI cases. When students exhibit influenza-like symptoms (such as fever, cough, sore throat or other symptoms), the school’s medical staff or teachers will report these cases by registration form of ILI case (online supplemental table 3). Concurrently, a morning inspection and registration system for illness-related absenteeism will be implemented. The attendance and potential ILI monitoring system is a directive launched by the Department of Education of Guangdong Province, ensuring a standardised approach across participating schools. This system facilitates the daily tracking of student attendance, with protocols in place for follow-up on unexplained absences, particularly to identify potential cases of ILI. Teachers or designated school staff are required to contact parents or guardians in the event of consecutive absences, to ascertain the reasons and identify any health-related concerns. Cases identified through the student or parent self-report will be obtained by questionnaires, telephone calls, emails or online platform reports.

Study outcomes

Primary outcome is the influenza vaccination rate. The influenza vaccination rate will be calculated as the number of vaccinated individuals divided by the total number of individuals, multiplied by 100%.

Secondary outcomes include the influenza vaccination health literacy level, influenza incidence, the ILI incidence and the influenza vaccine protection rate. Regarding the influenza vaccination health literacy level, each correct answer for the scale will be scored as one point, with incorrect answers receiving no points. The influenza incidence will be calculated as the number of individuals diagnosed with influenza divided by the total number of individuals, multiplied by 100%, The ILI incidence will be calculated as the number of ILI cases divided by the total number of participants, multiplied by 100%. The influenza vaccine protection rate will be calculated as the difference between the incidence rate in unvaccinated individuals and the incidence rate in vaccinated individuals, divided by the incidence rate in unvaccinated individuals, multiplied by 100%.

Despite the lack of prior validation for the questionnaire used to assess secondary outcomes, we believe its design is suitable for our study objectives. The questionnaire was meticulously developed to align with the educational level and cognitive abilities of primary school students, ensuring questions were both age-appropriate and culturally relevant. This tailored approach, combined with input from experts in paediatric health education and epidemiology, enhances the tool’s ability to accurately capture the nuances of health literacy related to influenza vaccination in this specific population. Moreover, the questionnaire’s structure, focusing on simple, direct questions with clear, binary response options, is designed to minimise confusion and maximise response accuracy, further supporting its suitability despite the validation limitations. Future iterations of this study including a validation phase for the questionnaire are warranted to strengthen the reliability of the findings.

Statistical analysis

Continuous variables will be described using means±SD or median (IQR), and comparisons will be made using two independent samples t-tests or Wilcoxon rank-sum tests. We will use the t-test due to its suitability for comparing means between two groups, especially when the population SD is unknown and the sample size does not warrant the assumption of a normal distribution. This method will be particularly appropriate for our study, enabling robust comparisons of outcomes such as health literacy levels between the intervention and control groups. Categorical variables will be described using frequency and composition ratios, and rate comparisons will be conducted using χ2 tests or Fisher’s exact probability method. The association between the level of influenza vaccination health literacy and vaccination willingness will be analysed using multivariate logistic regression.

To address the handling of missing data in our study, we will employ a combination of intention-to-treat (ITT), per-protocol and complete-case analyses. The ITT analysis will include all participants as randomised to account for non-adherence and drop-outs, thereby preserving the randomisation’s integrity. The per-protocol analysis will focus on participants who completed the intervention according to the study protocol, offering insights into the efficacy under ideal adherence. Additionally, we will conduct a complete-case analysis, which considers only those participants with complete data on all variables of interest. This approach will allow us to maintain the rigour of our statistical evaluation while acknowledging the limitations associated with missing data.

Quality control

Quality control will be conducted in accordance with the requisite quality control standards, with dedicated on-site quality control personnel assigned to oversee investigation and evaluation. These personnel should be proficient in various testing technical requirements and quality control points, and familiar with the on-site organisational process and division of responsibilities. Their primary responsibilities include on-site inspection of various investigation and evaluation operational processes, immediate correction of identified issues; on-site review of collected information, with rectification based on retest results; collection, summarisation and analysis of investigation and evaluation quality control issues, with timely reporting and sharing of these issues.

Patient and public involvement

Students and their parents, teachers and/or the public will not be involved in the design, or conduct, or reporting, or dissemination plans of this study.

Ethics and dissemination

This study follows the Declaration of Helsinki and the Chinese clinical trial research ethics and regulations. Before the commencement of the project, ethical approval has been sought from the Ethics Committee of the School of Public Health, Sun Yat-sen University. The research process respects the autonomy of students and schools. The primary schools selected for this study have an equal probability of being assigned to either the intervention or control group, ensuring the impartiality and fairness of the research. Prior to the initiation of the study, the lead researcher provided an overview of the study’s purpose, procedures and potential risks. Comprehensive informed consent forms, detailing the study’s intent, processes and potential risks, will be handed to both students and their guardians, and participation is strictly voluntary. Data confidentiality will be ensured through anonymisation and restricted access, with only the core study team able to view raw data. Provisions are also in place to address any adverse reactions or events related to the study or vaccination.

Findings from the study will be made accessible to both the scientific community and the public. Results are slated for submission to peer-reviewed journals, ensuring validation and broader reach within the research community. Beyond academic circles, outcomes will be relayed to key stakeholders, including school officials, health departments and community leaders, fostering informed decisions at the grassroots level. Additionally, feedback sessions, online postings and conference presentations are avenues being considered to ensure widespread dissemination and awareness.

Ethics statements

Patient consent for publication

References

Supplementary materials

  • Supplementary Data

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Footnotes

  • WX, JX and JC contributed equally.

  • Correction notice This article has been corrected since it was published. The name of the fourth author was misspelled.

  • Contributors LX, JX, XH, WX and JC initiated the study design and WX, AH, XH, JX, SH and JC helped with implementation. The draft of the manuscript was written and revised by LX and JC. All authors read and approved the manuscript.

  • Funding This work was supported by the Department of Education of Guangdong Province (grant number: 51000-42240006).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.