- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07508189
Communication Intervention to Improve Influenza Vaccination Rates Among Elderly in Can Tho (CIVECT)
April 3, 2026 updated by: Can Tho University of Medicine and Pharmacy
Effectiveness of Community-Based Communication Interventions to Improve Influenza Vaccination Rates Among the Elderly in Vietnam: A Cluster Randomized Controlled Trial
This study evaluates the effectiveness of a community-based communication intervention to increase influenza vaccination rates among the elderly (aged above 65) in Can Tho City, Vietnam.
Using a cluster randomized controlled trial design, the intervention includes direct counseling, social media engagement (Zalo), and educational materials targeting the elderly, their relatives, and local health workers.
The primary goal is to assess changes in vaccination coverage over a 9-month period.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The study employs a community-based interventional design with a control group. A total of 1,200 elderly participants (600 per group) will be recruited using multi-stage sampling. The intervention group receives a multi-component communication package:
- Training for local health workers and collaborators.
- Direct community communication sessions using leaflets.
- Social media updates and monthly household visits. The control group receives standard health information. Effectiveness is measured by comparing pre- and post-intervention vaccination rates using the Difference-in-Differences (DID) analytical method.
Study Type
Interventional
Enrollment (Estimated)
1200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Can Tho City
-
Can Tho, Can Tho City, Vietnam, 900000
- Can Tho University of Medicine and Pharmacy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Residents living in selected wards/communes in Can Tho City for at least 6 months.
- Aged above 65 years.
- Mentally and physically capable of participating in interviews and receiving communication interventions.
- Agree to participate in the study and provide informed consent.
Exclusion Criteria:
- Individuals with severe cognitive impairment or dementia.
- Individuals with contraindications to influenza vaccination.
- Planning to move out of the study area during the 12-month follow-up period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multi-component Health Communication
Elderly participants in this arm will receive a multi-component health communication package, including direct counseling from health workers, social media engagement via Zalo, and printed materials (leaflets).
|
A 12-month intervention program consisting of: 1) Direct health counseling; 2) Weekly educational content shared via Zalo; and 3) Distribution of influenza vaccination leaflets.
|
|
No Intervention: Routine Immunization Information
Participants in this arm receive standard care and routine immunization information provided by the local health station without the additional communication package.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Influenza Vaccination Coverage Rate
Time Frame: Baseline (Month 0) and Post-intervention (Month 12)
|
The primary outcome is the change in the proportion of elderly participants who received the influenza vaccine from baseline to 12 months.
Effectiveness will be evaluated by comparing the intervention and control groups using the Difference-in-Differences (DID) analytical method.
|
Baseline (Month 0) and Post-intervention (Month 12)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 27, 2026
First Submitted That Met QC Criteria
March 27, 2026
First Posted (Actual)
April 2, 2026
Study Record Updates
Last Update Posted (Actual)
April 8, 2026
Last Update Submitted That Met QC Criteria
April 3, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIHE IRB - 40/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data (IPD) will not be shared with other researchers to ensure the privacy and confidentiality of the study participants, in accordance with local ethical guidelines and institutional policies.
Only aggregated results will be made available through publications.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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