- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07921121
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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Odette Wegwarth, Prof. Dr.
- Número de telefone: +49 30 450 531 074
- E-mail: odette.wegwarth@charite.de
Estude backup de contato
- Nome: Miriam K Rumpel, M.Sc.
- Número de telefone: +49 30 450 531 058
- E-mail: miriam.rumpel@charite.de
Locais de estudo
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State of Berlin
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Berlin, State of Berlin, Alemanha, 10117
- Recrutamento
- Charité - Universitätsmedizin Berlin, Berlin-Mitte
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- German citizens
- Colombian citizens
Exclusion Criteria:
- Citizens of all other countries
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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) |
|
Comparador Ativo: 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) |
|
Comparador de Placebo: 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) |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Relative frequency of informed decisions based on respective informational material
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2026_Y4F_WP5.3
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