Contagious Misinformation Trial (CMT)

January 20, 2020 updated by: Helena Nordenstedt, Karolinska Institutet

The Contagious Misinformation Trial: Debunking Prevalent Misinformation About an Infectious Disease Through Audio Dramas in Freetown, Sierra Leone

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sierra Leone
    • Western Area
      • Freetown, Western Area, Sierra Leone
        • Focus1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Deafness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Up to 2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 2 months
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.
Up to 2 months
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.
Up to 2 months
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.
Up to 2 months
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.
Up to 2 months
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.
Up to 2 months
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.
Up to 2 months
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.
Up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Helena Nordenstedt, MD PHD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMT2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After publication of the primary analysis and study results, the anonymised data will be published in a public repository

IPD Sharing Time Frame

January 2022

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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