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Contagious Misinformation Trial (CMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04112680
Recruitment Status : Completed
First Posted : October 2, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Helena Nordenstedt, Karolinska Institutet

Brief Summary:
In the Contagious Misinformation Trial the investigators aim to debunk prevalent misinformation about an infectious disease using two evidence-based methods of debunking. The two debunking methods are packaged in two audio dramas of 4 episodes each, which will be sent to the WhatsApp of participants who are randomised to intervention group 1 or 2. The control group will receive audio messages about a different topic. The primary outcome is the reduction in belief in two misinformation statements about the infectious diseases.

Condition or disease Intervention/treatment Phase
Misinformation Behavioral: Debunking Misinformation through Audio Dramas Behavioral: Control group audio jingles Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Interventional study, with 3 arms (2 intervention groups, 1 control group) to test communication elements of audio dramas aiming to counter prevalent belief in misinformation about an infectious disease in Freetown, Sierra Leone
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

Participant will not know the group they are assigned to, as all groups (also the control group) will receive audio messages.

The investigator and outcomes assessors will only be handed an anonymised data set.

Primary Purpose: Other
Official Title: The Contagious Misinformation Trial: Debunking Prevalent Misinformation About an Infectious Disease Through Audio Dramas in Freetown, Sierra Leone
Actual Study Start Date : October 7, 2019
Actual Primary Completion Date : December 21, 2019
Actual Study Completion Date : December 21, 2019

Arm Intervention/treatment
Experimental: Intervention group 1
Audio messages in this group are focussed on providing a Plausible Alternative to the misinformation
Behavioral: Debunking Misinformation through Audio Dramas
The audio dramas (one drama of 4 episodes per intervention group), aim to debunk misinformation about an infectious disease. The content of the two dramas differ in the two groups; in intervention group 1, the drama will state the misinformation and provide a plausible alternative, delivered through a trusted source, in line with world views. In intervention group 2, the audio drama will avoid mentioning the misinformation and instead only state the correct information about the infectious disease

Experimental: Intervention group 2
Audio messages in this group focus on Avoiding the Misinformation and instead only provide the correct information
Behavioral: Debunking Misinformation through Audio Dramas
The audio dramas (one drama of 4 episodes per intervention group), aim to debunk misinformation about an infectious disease. The content of the two dramas differ in the two groups; in intervention group 1, the drama will state the misinformation and provide a plausible alternative, delivered through a trusted source, in line with world views. In intervention group 2, the audio drama will avoid mentioning the misinformation and instead only state the correct information about the infectious disease

Placebo Comparator: Control group
Audio messages in this control group are on a different topic
Behavioral: Control group audio jingles
The control group will receive audio jingles about exclusive breastfeeding




Primary Outcome Measures :
  1. Change in the belief in misinformation [ Time Frame: Up to 2 months ]
    The change in the belief in misinformation will be measured through Yes/No questions in the baseline and follow-up surveys. Using logistic regression models, the prevalence of the belief in misinformation about 2 aspects of an infectious disease compared to the control group will be analysed using an intention-to-treat and per-protocol analysis


Secondary Outcome Measures :
  1. Inadvertent promotion of misinformation: the backfire effect [ Time Frame: Up to 2 months ]
    To test whether the interventions might inadvertently have promoted the belief in misinformation, the same yes/no questions as the primary outcome will be used in ordinal logistic regression models to analyse if the there has been a backfire effect in the intervention groups, compared to the control group.

  2. As treated analysis of primary outcomes [ Time Frame: Up to 2 months ]
    The Yes/No questions of the primary outcomes will be tested in an as-treated analysis. The investigators will only include participants who can correctly recall the basic storylines of the audio messages.

  3. Knowledge about preventive methods [ Time Frame: Up to 2 months ]
    Using an open question, asking the respondent to name up to 3 preventive methods, a score will be created. For every correct answer, the participants gets a point, and one point is subtracted for every wrong answer; leading to a potential score of -3 to +3. Ordinal logistic regression models will be fitted to compare the scores of the intervention groups with the control group.

  4. Health-related discussions among family/friend [ Time Frame: Up to 2 months ]
    The question asking whether the participant has discussed the content of the audio messages will be used for this analysis, together with the question about how often the participant discussed health issues with family/friends. Logistic regression models will be fitted to test whether the interventions have influenced health-related discussions with family or friends, as compared to the control group.

  5. Method of administration [ Time Frame: Up to 2 months ]
    To understand if the intervention works outside of WhatsApp, 60 additional people will be recruited who do not have WhatsApp. Participants will instead be called and listen to the audio dramas on the phone; 30 will listen to the audio drama of intervention group 1 and 30 will listen to the audio drama of intervention group 2. The two primary outcomes will be analysed similar to the primary outcome analysis (ITT and per protocol) among the 2 groups and compared to the control group, as well as to their equivalent group of respondents with WhatsApp.

  6. Differences in self-efficacy [ Time Frame: Up to 2 months ]
    Participants will answer 3 questions about their perceived self-efficacy on 3 specific preventive behaviours. Answers are on a 5-item scale: from not at all true to exactly true. Ordinal logistic regression models will be specified to test whether the interventions had an influence on people's self-efficacy about three specific preventive behaviours, compared to the control group.

  7. Risk perception & preventive methods [ Time Frame: Up to 2 months ]
    Risk perception about the infectious disease will be measured with a question that asks how likely it is that the participants gets the disease in the next year. A question which asks what kind of actions the participants has undertaken, or is planning to undertake, to prevent infection with the disease - will be used to assess if and what kind of actions are taken. Several analyses will be carried out to test whether the intervention influenced risk perception and preventive methods. Furthermore, analyses will be carried out to determine if the a change in risk perception influenced preventive methods.

  8. Objective versus subjective learning [ Time Frame: Up to 2 months ]
    In the follow-up survey, there is a question asking if the participant feels like he/she learned from the audio messages (yes/no question). A Chi-Square analysis will be done to determine whether those who feel like they learned also learned objectively, using the two primary outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults
  • Living in Freetown
  • In possession of a mobile phone that has WhatsApp
  • Fluent in Krio

Exclusion Criteria:

  • Deafness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112680


Locations
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Sierra Leone
Focus1000
Freetown, Western Area, Sierra Leone
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Helena Nordenstedt, MD PHD Karolinska Institutet
  Study Documents (Full-Text)

Documents provided by Helena Nordenstedt, Karolinska Institutet:
Statistical Analysis Plan  [PDF] September 25, 2019
Study Protocol  [PDF] September 25, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helena Nordenstedt, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04112680    
Other Study ID Numbers: CMT2019
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publication of the primary analysis and study results, the anonymised data will be published in a public repository
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helena Nordenstedt, Karolinska Institutet:
Misinformation
Communication
Infectious diseases
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Disease Attributes
Pathologic Processes