NCT07508189

Brief Summary

This study evaluates the effectiveness of a multi-component community-based communication intervention to increase influenza vaccination rates among adults aged above 65 years in Can Tho City, Vietnam. Using a cluster randomised controlled trial design with stratified lottery randomisation, four study sites were selected from eight sites surveyed in a prior study: O Mon Ward and Truong Thanh Commune (intervention); Phuoc Thoi Ward and Truong Xuan Commune (control). The intervention includes community health education sessions, healthcare worker training, household visits, health communication banners, and Zalo-based vaccination reminders, delivered over 12 months (September 2025 to September 2026). Effectiveness is assessed by comparing pre- and post-intervention outcomes using Difference-in-Differences (DID) analysis.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Sep 2025Dec 2026

Study Start

First participant enrolled

September 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

March 27, 2026

Last Update Submit

June 30, 2026

Conditions

Keywords

Influenza VaccinesElderlyHealth CommunicationVaccination CoverageCommunity-based InterventionVietnam

Outcome Measures

Primary Outcomes (1)

  • Influenza vaccination uptake in the preceding 12 months

    Proportion of participants who received influenza vaccination in the 12 months prior to survey, assessed by self-report. Baseline assessed August 2025; follow-up assessed September 2026. Intervention effect estimated using Difference-in- Differences (DID) regression comparing change between intervention and control clusters.

    Up to 12 months

Secondary Outcomes (6)

  • Influenza vaccination in calendar year 2025

    Up to 12 months

  • Influenza vaccination intention

    Baseline and up to 12 months

  • Healthcare worker vaccination counselling

    Baseline and up to 12 months

  • Influenza knowledge score

    Baseline and up to 12 months

  • Vaccine hesitancy score (WHO-SAGE Vaccine Hesitancy Scale)

    Baseline and up to 12 months

  • +1 more secondary outcomes

Study Arms (2)

Multi-component Health Communication

EXPERIMENTAL

Adults aged \>65 years in 2 intervention clusters (O Mon Ward and Truong Thanh Commune) receive a multi-component package: Phase 1 (Sep 2025): (1) Two community health education sessions/ site for older adults and one family member, with influenza leaflets. (2) One HCW capacity-building workshop/site (O Mon: n=30; Truong Thanh: n=20). (3) Thirty household visits/site by community health volunteers. Phase 2 (Sep 2025-Sep 2026): (4) Health communication banners at health stations and community centres. (5) HCW point-of-care vaccination counselling at all clinical contacts. (6) Zalo-based weekly reminders and educational content (Dec 2025-Jan 2026).

Behavioral: Multi-component Health Communication Package

Routine Immunization Information

NO INTERVENTION

Participants in this arm receive standard care and routine immunization information provided by the local health station without the additional communication package.

Interventions

A 12-month cluster-level communication intervention (Sep 2025-Sep 2026) delivered in two phases to all adults aged \>65 years in intervention clusters: Phase 1 (Sep 2025): (1) Two community health education sessions/site with influenza leaflets for older adults and family members; (2) HCW capacity-building workshop/site (O Mon: n=30; Truong Thanh: n=20); (3) Thirty household visits/site by community health volunteers. Phase 2 (ongoing): (4) Health communication banners at health stations and community centres; (5) HCW point-of-care vaccination counselling at all clinical contacts; (6) Zalo-based weekly educational content and vaccination reminders (Dec 2025-Jan 2026).

Multi-component Health Communication

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho University of Medicine and Pharmacy

Can Tho, Can Tho City, 900000, Vietnam

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the community-based health communication intervention, masking of participants and investigators is not feasible.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A cluster randomized controlled trial where wards/communes are the unit of randomization. Participants in intervention clusters receive multi-component communication, while control clusters receive standard care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 2, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations