MisinformationCMTNCT04112680
Contagious Misinformation Trial
A study testing Debunking Misinformation through Audio Dramas in people with Misinformation, run by Karolinska Institutet at 1 site in Sierra Leone.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Misinformation
- What is being tested?
- Debunking Misinformation through Audio Dramas
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 1 siteSierra Leone
- Study dates
- 7 Oct 2019to 21 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults
- Living in Freetown
- In possession of a mobile phone that has WhatsApp
- Fluent in Krio
Who cannot join
- Deafness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Misinformation
- Being tested
- Debunking Misinformation through Audio Dramas, Control group audio jingles
- Keywords
- Misinformation, Communication, Infectious diseases
- Medical subject headings
- Communication, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debunking Misinformation through Audio DramasBehavioural
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
Control group audio jinglesBehavioural
The control group will receive audio jingles about exclusive breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1 | Experimental | Audio messages in this group are focussed on providing a Plausible Alternative to the misinformation Receives: Behavioral: Debunking Misinformation through Audio Dramas |
| Intervention group 2 | Experimental | Audio messages in this group focus on Avoiding the Misinformation and instead only provide the correct information Receives: Behavioral: Debunking Misinformation through Audio Dramas |
| Control group | Placebo comparator | Audio messages in this control group are on a different topic Receives: Behavioral: Control group audio jingles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the belief in misinformation
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
Measured: Up to 2 months
Secondary outcomes (8)
Inadvertent promotion of misinformation: the backfire effect
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.
Measured: Up to 2 months
As treated analysis of primary outcomes
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.
Measured: Up to 2 months
Knowledge about preventive methods
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.
Measured: Up to 2 months
Health-related discussions among family/friend
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.
Measured: Up to 2 months
Method of administration
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.
Measured: Up to 2 months
Differences in self-efficacy
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.
Measured: Up to 2 months
Risk perception & preventive methods
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.
Measured: Up to 2 months
Objective versus subjective learning
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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start7 Oct 2019
- Primary completion21 Dec 2019
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MisinformationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Nordenstedt, Karolinska Institutet
- Investigators
- Helena Nordenstedt, MD PHD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112680
- Sponsor's protocol ID
- CMT2019
- Acronym
- CMT
- Status last verified
- Jan 2020
- First submitted
- 27 Sep 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of the primary analysis and study results, the anonymised data will be published in a public repository
Publications
Winters M, Oppenheim B, Sengeh P, Jalloh MB, Webber N, Pratt SA, Leigh B, Molsted-Alvesson H, Zeebari Z, Sundberg CJ, Jalloh MF, Nordenstedt H. Debunking highly prevalent health misinformation using audio dramas delivered by WhatsApp: evidence from a randomised controlled trial in Sierra Leone. BMJ Glob Health. 2021 Nov;6(11):e006954. doi: 10.1136/bmjgh-2021-006954.
PubMed 34758970
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contagious Misinformation Trial: Debunking Prevalent Misinformation About an Infectious Disease Through Audio Dramas in Freetown, Sierra Leone
- ClinicalTrials.gov ID
- NCT04112680
- Acronym / sponsor ID
- CMT / CMT2019
- Conditions
- Misinformation
- Keywords
- Misinformation, Communication, Infectious diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Experimental | Behavioral: Debunking Misinformation through Audio DramasAudio messages in this group are focussed on providing a Plausible Alternative to the misinformation |
| Intervention group 2 | Experimental | Behavioral: Debunking Misinformation through Audio DramasAudio messages in this group focus on Avoiding the Misinformation and instead only provide the correct information |
| Control group | Placebo comparator | Behavioral: Control group audio jinglesAudio messages in this control group are on a different topic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults
- Living in Freetown
- In possession of a mobile phone that has WhatsApp
- Fluent in Krio
Key exclusion criteria (1 listed)
- Deafness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debunking Misinformation through Audio DramasThe 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 | Behavioural | Intervention group 1, Intervention group 2 |
| Control group audio jinglesThe control group will receive audio jingles about exclusive breastfeeding | Behavioural | Control group |
Primary outcome
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
8 secondary outcomes
Inadvertent promotion of misinformation: the backfire effect
Time frame: Up to 2 months
As treated analysis of primary outcomes
Time frame: Up to 2 months
Knowledge about preventive methods
Time frame: Up to 2 months
Health-related discussions among family/friend
Time frame: Up to 2 months
Method of administration
Time frame: Up to 2 months
Differences in self-efficacy
Time frame: Up to 2 months
Risk perception & preventive methods
Time frame: Up to 2 months
Objective versus subjective learning
Time frame: Up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 34758970Winters M, Oppenheim B, Sengeh P, Jalloh MB, Webber N, Pratt SA, Leigh B, Molsted-Alvesson H, Zeebari Z, Sundberg CJ, Jalloh MF, Nordenstedt H. Debunking highly prevalent health misinformation using audio dramas delivered by WhatsApp: evidence from a randomised controlled trial in Sierra Leone. BMJ Glob Health. 2021 Nov;6(11):e006954. doi: 10.1136/bmjgh-2021-006954.
- Individual participant dataSharing planned: Yes. After publication of the primary analysis and study results, the anonymised data will be published in a public repository
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Protecting Against HIV Vaccine Misinformation With Adolescent Girls and Young Women in South Africa
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Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Nordenstedt, MD PHD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debunking Misinformation through Audio Dramas in people with Misinformation, run by Karolinska Institutet at 1 site in Sierra Leone.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the belief in misinformation (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04112680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.