カントーにおける高齢者インフルエンザワクチン接種率向上のためのコミュニケーション介入 (CIVECT)
ベトナムにおける高齢者のインフルエンザワクチン接種率向上のための地域コミュニティに基づくコミュニケーション介入の有効性：クラスター無作為化比較試験
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
Can Tho City
-
Can Tho、Can Tho City、ベトナム、900000
- Can Tho University of Medicine and Pharmacy
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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). |
|
介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Influenza vaccination uptake in the preceding 12 months
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Influenza vaccination in calendar year 2025
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
|
|
Willingness to pay for influenza vaccination
時間枠：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
|
協力者と研究者
協力者
協力者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- NIHE IRB - 40/2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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