Intervention de communication pour améliorer les taux de vaccination contre la grippe chez les personnes âgées à Cần Thơ (CIVECT)
Efficacité des interventions de communication communautaires pour améliorer les taux de vaccination contre la grippe chez les personnes âgées au Vietnam : un essai randomisé en grappes contrôlé
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study employs a cluster randomised controlled trial (cluster RCT) design with a repeated cross-sectional approach. The unit of randomisation is the cluster (ward or commune).
RANDOMISATION:
From eight study sites surveyed in Objective 1 (four urban wards and four rural communes in Can Tho City), four sites were selected by stratified lottery randomisation. Within each stratum (urban and rural), one site was randomly assigned to the intervention group and one to the control group by lottery draw without investigator discretion:
- Intervention: O Mon Ward (urban) and Truong Thanh Commune (rural)
- Control: Phuoc Thoi Ward (urban) and Truong Xuan Commune (rural)
PARTICIPANTS:
All eligible permanent residents aged above 65 years at each study site were invited to participate. Data are collected at two independent cross-sectional time points:
- T0: Baseline survey, August 2025 (n=952)
- T1: Follow-up survey, September 2026 (n=approximately 1,200) Participants at T0 and T1 are not necessarily the same individuals; the design captures population-level changes within randomised clusters.
INTERVENTION (12 months: September 2025 to September 2026):
The 12-month duration encompasses both active implementation and the time required for knowledge, attitude, and behaviour change.
Phase 1 (September 2025, intensive activities):
- Two community health education sessions per intervention site for adults aged >65 years and one cohabiting family member, with distribution of printed educational leaflets on influenza disease and vaccination. Attendance: O Mon Ward: Session 1 = 60 older adults + 40 family members, Session 2 = 57 older adults + 35 family members; Truong Thanh Commune: Session 1 = 60 + 38, Session 2 = 50 + 30.
- One capacity-building workshop per site for healthcare workers and community health volunteers in vaccination counselling (O Mon Ward: n=30; Truong Thanh Commune: n=20).
- Thirty household visits per site by trained community health volunteers to reinforce vaccination counselling.
Phase 2 (September 2025 to September 2026, ongoing):
- Health communication banners displayed at health stations and community information centres throughout the intervention period.
- Healthcare worker vaccination counselling integrated into all routine clinical contacts at intervention site health stations.
- Zalo-based digital communication: weekly educational content and personalised vaccination reminders (December 2025 to January 2026, coinciding with peak influenza season in southern Vietnam).
CONTROL GROUP:
Received routine primary healthcare only, with no additional study-related activities.
ANALYSIS:
Effectiveness is measured using Difference-in-Differences (DID) regression, comparing changes between T0 and T1 across intervention and control clusters. Models use multivariable logistic regression (binary outcomes) and linear regression (continuous outcomes), adjusted for sociodemographic covariates. Intraclass correlation coefficients (ICC) were estimated for all outcomes and found to be negligible (ICC < 0.01), confirming the appropriateness of individual-level DID analysis.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Can Tho City
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Can Tho, Can Tho City, Viêt Nam, 900000
- Can Tho University of Medicine and Pharmacy
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Multi-component Health Communication
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). |
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). |
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Aucune 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Influenza vaccination uptake in the preceding 12 months
Délai: Up to 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Influenza vaccination in calendar year 2025
Délai: Up to 12 months
|
Proportion vaccinated against influenza during calendar year 2025, assessed by self-report at follow-up (September 2026). |
Up to 12 months
|
|
Influenza vaccination intention
Délai: Baseline and up to 12 months
|
Proportion intending to receive influenza vaccination in the next 12 months, assessed by self-report at baseline (August 2025) and follow-up (September 2026). |
Baseline and up to 12 months
|
|
Healthcare worker vaccination counselling
Délai: Baseline and up to 12 months
|
Proportion who received influenza vaccination counselling from a healthcare worker or community health volunteer in the preceding 12 months, assessed by self-report at baseline (August 2025) and follow-up (September 2026). |
Baseline and up to 12 months
|
|
Influenza knowledge score
Délai: Baseline and up to 12 months
|
Total knowledge score (0-6) on influenza disease aetiology, transmission, complications, and vaccine characteristics. Higher scores indicate greater knowledge. Assessed at baseline (August 2025) and follow-up (September 2026). Analysed using linear regression DID. |
Baseline and up to 12 months
|
|
Vaccine hesitancy score (WHO-SAGE Vaccine Hesitancy Scale)
Délai: Baseline and up to 12 months
|
Vaccine hesitancy measured using the WHO-SAGE Vaccine Hesitancy Scale (Vietnamese-adapted version). Higher scores indicate greater hesitancy. Assessed at baseline (August 2025) and follow-up (September 2026). Analysed using linear regression DID. |
Baseline and up to 12 months
|
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Willingness to pay for influenza vaccination
Délai: Baseline and up to 12 months
|
Proportion willing to pay out-of-pocket costs for influenza vaccination, assessed by self-report binary question at baseline (August 2025) and follow-up (September 2026). |
Baseline and up to 12 months
|
Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NIHE IRB - 40/2025
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
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