Trial document




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  DRKS00023650

Trial Description

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Title

An entertainment-education approach to improve vaccine confidence during the COVID-19 pandemic: an online randomized controlled experiment with 24,000 participants

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Entertainment-education (E-E) media can promote general perception and behavior intent towards health-related practices. Months after the outbreak of coronavirus disease 2019 (COVID-19), research has emerged highlighting the essential role of interventions to improve general public confidence towards COVID-19 vaccines. To improve vaccine confidence, we designed 3 short, animated videos to promote general vaccine acceptance that can be distributed globally through social media platforms, because of their wordless and multi-cultural form. However, the video’s effectiveness is remained to explore.

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Brief Summary in Scientific Language

Months after the outbreak of the COVID-19 pandemic, research has emerged highlighting the critical role of interventions to increase general vaccine confidence globally, even before a vaccine for COVID-19 becomes available to the public. Information has been disseminated by the traditional mass media on vaccine efficacy and safety, however, it remains unclear whether these messages have reached key target populations in ways that are accessible to them and translate into behavioral intent to accept vaccines.
To address these challenges, we have designed three short, animated, wordless videos, featuring multi-cultural characters, to convey foundational messages promoting general vaccine confidence. We will compare the effectiveness of the following 3 approaches: 1. storytelling-informational approach, 2. storytelling-analogy approach, 3. storytelling-emotion-focused approach and 4. no video.

These video interventions can be rapidly distributed globally, through social media channels, overcoming language and literacy barriers.
For our primary outcome, we will measure vaccine hesitancy and for secondary outcomes, we will measure behavioral intent to seek vaccination and the participants level of hope.

To evaluate these effects we propose to randomly order and assign our video intervention and a survey to 12,000 online participants in each of two countries, China and the United States of America.
We will measure differences in outcome by assigning the participants equally and randomly to 4 arms: intervention arm a, which will receive the storytelling-informational approach video followed by the survey; intervention arm b, which will receive the storytelling-analogy approach video followed by the survey; intervention arm c, which will receive the storytelling-emotion-focused approach video followed by the survey and a control arm, that will receive the survey first, followed by a collage of the three videos.
Results will be used to scientifically support the broader distribution of this short, animated video as well as optimizing the design of future videos for rapid public health communication.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

An applicant needs to hand in a letter of intent (LoI) to be able to get access to the data. The LoI can be accepted or declined. In case of acceptance all data will be anonymized.

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Organizational Data

  •   DRKS00023650
  •   2021/02/09
  •   [---]*
  •   yes
  •   Approved
  •   59503, Stanford University - Research Compliance Office IRB Number: 6208 (Panel: 8)
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Secondary IDs

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Health Condition or Problem studied

  •  
    Intention towards vaccines in general and COVID-19
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Interventions/Observational Groups

  •   Intervention arm a receives the storytelling-informational approach video followed by the survey
  •   Intervention arm b receives the storytelling-analogy approach video followed by the survey
  •   Intervention arm c receives the storytelling-emotion-focused approach video followed by the survey
  •   Control arm receives the survey first, followed by a collage of the three videos.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

1. Establish the effectiveness of the video in reducing COVID-19 vaccine hesitancy.

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Secondary Outcome

2. Establish the effectiveness of each of the videos in increasing behavioral intent towards COVID-19 vaccination.
3. Establish the effectiveness of each of the videos in increasing participants’ level of hope

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Countries of Recruitment

  •   United States
  •   China
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2021/04/01
  •   24000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   59   Years
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Additional Inclusion Criteria

All men and women between the ages of 18 and 59 years that are registered on the ProA or Kurundata platform will be eligible to participate in the study. The videos contain no speech and are therefore language independent. We will translate the English questionnaire into Chinese. Participants from USA must have reading competency in English and participants from China must have reading competency in Chinese to participate in the study.

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Exclusion Criteria

Exclusion criteria for all data collection is those who do not meet the above listed inclusion criteria. If a participant reports an out of range age, or cannot read one of the translated languages, the ProA or Kurundata platform will inform the participant that they are not eligible for participation in our study. Participants will be automatically timed-out from the online platform if they take more than 45 minutes to complete the study. The data will then not be used for evaluation.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Heidelberg Institute of Global Health, University of Heidelberg
    • Mr.  Prof. Dr.  Till  Bärnighausen 
    • 130.3 Im Neuenheimer Feld
    • 69120  Heidelberg
    • Germany
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    • Stanford University
    • Ms.  Dr.  Maya  Adam 
    • 291 Campus Drive Li Ka Shing Building
    • 94305-510  Stanford
    • United States
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    • Stanford University
    • Ms.  Dr.  Maya  Adam 
    • 291 Campus Drive Li Ka Shing Building
    • 94305-510  Stanford
    • United States
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Sources of Monetary or Material Support

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    • Heidelberg Institute of Global Health, University of Heidelberg
    • Mr.  Prof. Dr.  Till  Bärnighausen 
    • 130.3 Im Neuenheimer Feld
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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