Assessment of Communication Interventions on Vaccination Knowledge and Acceptance (Y4F WP5/3)
Effectiveness Assessment of Communication Interventions to Improve Vaccination Knowledge and Acceptance
An online randomized controlled trial (RCT) examining the effectiveness of communication measures regarding TBE vaccination in the European context and yellow fever vaccination in the South American context on an informed vaccination decision. Building on an exploratory qualitative focus group study conducted in 2024 with vaccine-hesitant individuals (Ethics Committee Approval Number EA1/119/24) and an exploratory quantitative study conducted in 2025 among the general population in Germany and Colombia (Ethics Committee Approval Number EA2/112/25), the communication measures were designed to improve education about vaccinations and to increase individual willingness to be vaccinated.
調査の概要
状態
詳細な説明
The study design consists of an online survey. The questionnaire and the communication measures were developed in collaboration with the following partners: the Amsterdam Institute for Global Health and Development (AIGHD) in Amsterdam, the Netherlands, and CIDEIM (Centro Internacional de Entrenamiento e Investigaciones Médicas) in Cali, Colombia, based on the findings of the previous focus group studies and the subsequent quantitative study on the prevalence of knowledge about and acceptance of novel (flavivirus) vaccines and perceived barriers to vaccination among the general population in Germany and Colombia.
Potential participants will be invited to participate in the study by the panel provider Toluna via a link in an email. Individuals who express their willingness to participate will first be asked questions about their sociodemographic background, their vaccination status against TBE (Germany) or yellow fever (Colombia), as well as their perception of risk regarding TBE or yellow fever and the associated vaccinations.
Participants will then be randomly assigned in a 1:1:1 ratio to one of three study arms:
- Control group (in Germany, a vaccination check based on the COVID-19 vaccination check on infektionsschutz.de; in Colombia, an educational video about the yellow fever vaccination from the Colombian Ministry of Health)
- Intervention group 1: Information format A (website)
- Intervention group 2: Information format B (slideshow/carousel)
In both countries, the intervention formats are implemented in the same way; only the vaccination being addressed differs (TBE in Germany, yellow fever in Colombia).
Within the two intervention groups, A and B, there is also a second randomized assignment to a presentation of an established (inactivated vaccine or live vaccine) versus a novel vaccine technology ("NovaCarrier"). This second randomization ensures that the assignment to vaccine technologies within the respective formats is not systematically linked to other participant characteristics. It serves exclusively to explore possible effects of the vaccine technologies on attitudes and intentions and does not form the basis of the primary case number planning.
Participants who view the materials featuring the hypothetical novel vaccine technology are transparently informed at the end of the study that this is a hypothetical technology.
Following the intervention, all participants will complete an adapted Informed Choice questionnaire (Marteau et al., 2001), which assesses risk understanding, knowledge, attitudes, and intention to be vaccinated against TBE or yellow fever. Subsequently, risk perception is assessed again after viewing an informational piece, and finally, participantsare asked two open-ended questions about safety and information needs regarding vaccinations.
The drafted communication measures will first be tested in a pilot study (n = 150; 75 participants per country) in order to adjust the materials to be developed before the main study (n = 1,374; 687 participants per country) if necessary. For this pilot study, the same questionnaire as for the main study will be used, with the addition of three open-ended questions regarding the information formats. The pilot study is not intended for final hypothesis testing, but solely to optimize the informational materials to be tested and, if necessary, the survey questions.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Odette Wegwarth, Prof. Dr.
- 電話番号:+49 30 450 531 074
- メール:odette.wegwarth@charite.de
研究連絡先のバックアップ
- 名前:Miriam K Rumpel, M.Sc.
- 電話番号:+49 30 450 531 058
- メール:miriam.rumpel@charite.de
研究場所
-
-
State of Berlin
-
Berlin、State of Berlin、ドイツ、10117
- 募集
- Charité - Universitätsmedizin Berlin, Berlin-Mitte
-
-
参加基準
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:
- German citizens
- Colombian citizens
Exclusion Criteria:
- Citizens of all other countries
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:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ:Intervention group 1 (website)
Participants are shown informational material A (website) before completing an adapted informed choice questionnaire that assesses participant risk understanding, knowledge, attitudes, and intention to get vaccinated against TBE/yellow fever. |
Participants are shown informational material A (website) |
|
アクティブコンパレータ:Intervention group 2 (slideshow/carousel)
Participants are shown informational material B (slideshow/carousel) before completing an adapted informed choice questionnaire that assesses participant risk understanding, knowledge, attitudes, and intention to get vaccinated against TBE/yellow fever. |
Participants are shown informational material B (slideshow/carousel) |
|
プラセボコンパレーター:Control group (vaccine check)
Participants are shown the control informational material (vaccine check) before completing an adapted informed choice questionnaire that assesses participant risk understanding, knowledge, attitudes, and intention to get vaccinated against TBE/yellow fever. |
Participants are shown the control informational material (vaccine check) |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Relative frequency of informed decisions based on respective informational material
時間枠:Immediately post intervention
|
The relative frequency of informed decisions based on the respective materials developed. Participants are classified into "informed" and "uninformed" based on their responses and the instrument developed my Marteau et al. (2001) |
Immediately post intervention
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2026_Y4F_WP5.3
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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