DengueNCT07002021
Effectiveness Evaluation of the "Mosquito-Free Campus" Initiative on Dengue Fever Prevention and Control: A Cluster Randomized Controlled Trial
A study testing Health education in people with Dengue and Infection Prevention, run by Sun Yat-sen University.
Trial summary
The goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on the score of the knowledge, attitudes, and practices (KAP) of dengue in in primary and middle school students in the city of Guangzhou and Foshan in China. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue, Infection Prevention
- What is being tested?
- Health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,940 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary and middle school students within the age range of 6-15 years.
- The primary and middle schools are located in Yuexiu District, Baiyun District of Guangzhou city or Nanhai District of Foshan City.
- The schools have the necessary infrastructure, management level and resource allocation to participate in dengue fever prevention and control.
- The schools agree to implement the intervention measures during the research period.
- The schools are willing to provide baseline data and participate in subsequent assessments before the intervention is implemented.
Who cannot join
- Unwilling to participate in the project.
- Participants (students or staff members) are unable to participate in the intervention or withdraw from the study due to personal reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on the score of the knowledge, attitudes, and practices (KAP) of dengue in in primary and middle school students in the city of Guangzhou and Foshan in China.
Individuals aged 6 to 15 years who are in grades 1-9 in primary schools in Guangzhou and Foshan 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 health education intervention focused on dengue prevention every semester for 6 months, while the control group will continue with their routine school health education for 6 months.
Researchers will compare the differences in the score of the KAP of dengue between the intervention and control groups after 6 months to see if health education can improve knowledge, attitudes and practices of dengue among primary and middle school students.
Read the detailed description
Introduction: Dengue is one of the fastest spreading mosquito-borne infectious diseases in the world. Guangdong, as the core epidemic area of dengue fever in China, has experienced many large outbreaks of dengue in history due to its warm and humid climate, dense urbanization, and frequent communication with Southeast Asia. However, prevention and control measures in schools remains suboptimal. This study aims to improve the knowledge, attitudes, and practices (KAP) of dengue prevention and control among students, and reduce the density of mosquito vectors and the risk of dengue transmission in primary and middle schools.
Methods and analysis: This cluster randomized controlled trial will enroll 3940 students from 20 primary and middle schools in Guangzhou and Foshan City, China. Schools will be randomized to an intervention group receiving dengue health education and environmental governance or a control group receiving routine health education. The primary outcome is scores of KAP of students. Secondary outcomes include environmental mosquito vector index. Data will be collected through questionnaires, campus environment inspection, 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 key stakeholders.
- Conditions
- Dengue, Infection Prevention
- Being tested
- Health education
- Keywords
- health education, schools, China
- Medical subject headings
- Dengue, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationCombination product
The intervention group will receive a health education intervention focused on dengue prevention and campus environmental governance, while the control group will continue with their standard school health education without any additional intervention. An health education including the knowledge of dengue fever, harm of mosquitoes, and measures of mosquito control, will be developed and reviewed by an expert group. The campus environmental governance includes organizing campus environmental cleaning once a week, focusing on removing mosquito breeding places such as water containers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will receive a health education intervention focused on dengue prevention every semester for 6 months Receives: Combination Product: Health education |
| No Intervention: Control | No intervention | The control group will continue with their routine school health education for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
scores of the knowledge, attitudes, and practices (KAP) of dengue
Regarding the knowledge, attitudes, and practices of dengue, each correct answer for the health literacy research questionnaire will be scored as one point, with incorrect answers receiving no points.
Measured: From enrollment to the end of intervention in 6 months
Secondary outcomes (1)
mosquito vector index
The mosquito vector index will be calculated as the number of mosquitoes captured in a fixed area divided by the total area.
Measured: From enrollment to the end of intervention in 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,940 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Xu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002021
- Sponsor's protocol ID
- SunYat-senU20250516
- Status last verified
- May 2025
- First submitted
- 25 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Evaluation of the "Mosquito-Free Campus" Initiative on Dengue Fever Prevention and Control: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07002021
- Acronym / sponsor ID
- SunYat-senU20250516
- Conditions
- Dengue, Infection Prevention
- Keywords
- health education, schools, China
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,940 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on the score of the knowledge, attitudes, and practices (KAP) of dengue in in primary and middle school students in the city of Guangzhou and Foshan in China.
Individuals aged 6 to 15 years who are in grades 1-9 in primary schools in Guangzhou and Foshan 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 health education intervention focused on dengue prevention every semester for 6 months, while the control group will continue with their routine school health education for 6 months.
Researchers will compare the differences in the score of the KAP of dengue between the intervention and control groups after 6 months to see if health education can improve knowledge, attitudes and practices of dengue among primary and middle school students.
Detailed description
Introduction: Dengue is one of the fastest spreading mosquito-borne infectious diseases in the world. Guangdong, as the core epidemic area of dengue fever in China, has experienced many large outbreaks of dengue in history due to its warm and humid climate, dense urbanization, and frequent communication with Southeast Asia. However, prevention and control measures in schools remains suboptimal. This study aims to improve the knowledge, attitudes, and practices (KAP) of dengue prevention and control among students, and reduce the density of mosquito vectors and the risk of dengue transmission in primary and middle schools.
Methods and analysis: This cluster randomized controlled trial will enroll 3940 students from 20 primary and middle schools in Guangzhou and Foshan City, China. Schools will be randomized to an intervention group receiving dengue health education and environmental governance or a control group receiving routine health education. The primary outcome is scores of KAP of students. Secondary outcomes include environmental mosquito vector index. Data will be collected through questionnaires, campus environment inspection, 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 key stakeholders.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Health educationThe intervention group will receive a health education intervention focused on dengue prevention every semester for 6 months |
| No Intervention: Control | No intervention | –The control group will continue with their routine school health education for 6 months. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Primary and middle school students within the age range of 6-15 years.
- The primary and middle schools are located in Yuexiu District, Baiyun District of Guangzhou city or Nanhai District of Foshan City.
- The schools have the necessary infrastructure, management level and resource allocation to participate in dengue fever prevention and control.
- The schools agree to implement the intervention measures during the research period.
- The schools are willing to provide baseline data and participate in subsequent assessments before the intervention is implemented.
Key exclusion criteria (2 listed)
- Unwilling to participate in the project.
- Participants (students or staff members) are unable to participate in the intervention or withdraw from the study due to personal reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health educationThe intervention group will receive a health education intervention focused on dengue prevention and campus environmental governance, while the control group will continue with their standard school health education without any additional intervention. An health education including the knowledge of dengue fever, harm of mosquitoes, and measures of mosquito control, will be developed and reviewed by an expert group. The campus environmental governance includes organizing campus environmental cleaning once a week, focusing on removing mosquito breeding places such as water containers. | Combination product | Intervention |
Primary outcome
scores of the knowledge, attitudes, and practices (KAP) of dengue
Time frame: From enrollment to the end of intervention in 6 months
Regarding the knowledge, attitudes, and practices of dengue, each correct answer for the health literacy research questionnaire will be scored as one point, with incorrect answers receiving no points.
1 secondary outcome
mosquito vector index
Time frame: From enrollment to the end of intervention in 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Health education in people with Dengue and Infection Prevention, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Xu, PhD ((86) 20-8733-5523, xulin27@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scores of the knowledge, attitudes, and practices (KAP) of dengue (time frame: From enrollment to the end of intervention in 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.