CoronavirusNCT04371419
COVID-19 Health Messaging to Underserved Communities
A study testing Messaging in people with Coronavirus, run by National Bureau of Economic Research, Inc. at 1 site in United States.
Trial summary
Recent data have shown that covid19 is disproportionately infecting and killing African Americans and Latinx people in the United States. The aim of the study is to determine which messages are most effective at increasing knowledge and changing behaviors that can protect individuals and their communities from the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus
- What is being tested?
- Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14,267 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2020to 26 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Hispanic and African-American adult individuals, men and women - oversample of those with less completed education Exclusion Criteria: children, those who do not identify as above
Trial locations and contacts
1 site in 1 country.
About this study
Recent data have shown that covid19 is disproportionately infecting and killing African Americans and Latinx people in the United States. The aim of the study is to determine which messages are most effective at increasing knowledge and changing behaviors that can protect individuals and their communities from the virus. To accomplish this aim, we plan to recruit approximately 20,000 Hispanic and African-American individuals and randomly assign them to videos that vary either the sender or the framing of the message, while providing the relevant public health information.
Read the detailed description
The following procedures will be followed. The research subjects will participate online.
- Doctors from MGH who express interest in participating will record messages according to our scripts (US Doctors Script African American, US Doctors Script Latinx). They will be instructed to film several different versions each.
- We will recruit a sample of Latinx and African American study participants from across the country through Lucid, an online survey firm that has access to a large subject pool.
- Participants will first read a consent script and give us their informed consent (US Doctors Messaging Consent)
- Participants will then navigate through the following steps
- Brief demographics survey questions (US Doctors Messaging Survey)
- Videos 1 and 2: Introduction, Acknowledgement, Social Distancing (US Doctors Script African American, US Doctors Script Latinx). Individuals in the control group will not see videos.
- Beliefs survey questions (US Doctors Messaging Survey)
- Video 3: Masks (US Doctors Script African American, US Doctors Script Latinx). Again, individuals in the control group will not see a video here.
- Main outcomes survey (US Doctors Messaging Survey)
- Control group is shown a version of all 3 videos at end (US Doctors Script African American, US Doctors Script Latinx).
- The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.
- Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.
- Whether the message includes an acknowledgment of "elephant in the room" issues for each target group: trust in the medical system or fear of deportation.
- Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.
- Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.
- Some individuals in a control group will only see messages after all surveying has been completed.
- Conditions
- Coronavirus
- Being tested
- Messaging
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MessagingBehavioural
- The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.
- Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.
- Whether the message includes an acknowledgment of "elephant in the room" issues for each target group: trust in the medical system or fear of deportation.
- Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.
- Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.
- Some individuals in a control group will see messages later.
| Study group | Role | What they receive |
|---|---|---|
| Control - CDC - Mask (Control) - Concordant | Experimental | Control Intro, CDC Social Distancing, Mask Control version delivered by minority doctor of same background as the recipient - other definitions are similar Receives: Behavioral: Messaging |
| Control - CDC - Mask (Control) - Discordant | Experimental | Control Intro, CDC Social Distancing, Mask Control version delivered by majority doctor of different background as the recipient - other definitions are similar Receives: Behavioral: Messaging |
| Control - MGH - Mask (Control) - Concordant | Experimental | Control Intro, MGH Social Distancing, Mask Control version delivered by concordant doctor Receives: Behavioral: Messaging |
| Control - MGH - Mask (Control) - Discordant | Experimental | Control Intro, MGH Social Distancing, Mask Control version delivered by discordant doctor Receives: Behavioral: Messaging |
| Ack. Discrimination- MGH - Mask (Control) - Concordant | Experimental | Introduction Acknowledges past discrimination, MGH doctor talks about Social Distancing, Mask Control all by concordant MD Receives: Behavioral: Messaging |
| Ack. Discrimination- MGH - Mask (Control) - Discordant | Experimental | Introduction Acknowledges past discrimination, MGH doctor talks about Social Distancing, Mask Control all by discordant MD Receives: Behavioral: Messaging |
| Ack. econ. circumstance- MGH - Mask (Control ) Concordant | Experimental | Intro econ. circumstance -MGH - Mask (Control ) Concordant Receives: Behavioral: Messaging |
| Ack. econ. circumstance - MGH - Mask (Control ) Discordant | Experimental | Not described Receives: Behavioral: Messaging |
| Control Intro - CDC - Mask (antiStigma) Concordant | Experimental | Control Intro - CDC - Mask (antiStigma) Concordant messenger Receives: Behavioral: Messaging |
| Control Intro - CDC - Mask (antiStigma) Discordant | Experimental | Control Intro - CDC - Mask (antiStigma) discordant messenger Receives: Behavioral: Messaging |
| Control - MGH - MaskS (antiStigma) Concordant messenger | Experimental | Control - MGH - MaskS (antiStigma) Concordant sender Receives: Behavioral: Messaging |
| Control- MGH-MaskS (antiStigma) Discordant messenger | Experimental | Control - MGH - MaskS (antiStigma) Discordant sender Receives: Behavioral: Messaging |
| Ack. Discrimination - MGH - MaskS (antiStigma) Concordant | Experimental | Acknowledge Discrimination - MGH - MaskS (antiStigma) Concordant sender Receives: Behavioral: Messaging |
| Ack. Discrimination - MGH - MaskS (antiStigma) Discordant | Experimental | Acknowledge Discrimination - MGH - MaskS (antiStigma) Discordant sender Receives: Behavioral: Messaging |
| Ack. Econ Hardship- MGH - Mask (antiStigma) Concordant | Experimental | Acknowledge Econ Hardship- MGH - Mask (antiStigma) Concordant sender Receives: Behavioral: Messaging |
| Ack. Econ Hardship- MGH - Mask (antiStigma) Discordant | Experimental | Acknowledge Econ Hardship- MGH - Mask (antiStigma) discordant sender Receives: Behavioral: Messaging |
| Info later - Pure Control | Placebo comparator | This group will not receive the videos but will receive information later. Receives: Behavioral: Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate for Knowledge Gaps: Control vs. Any Intervention
Incidence rate for knowledge gaps is the count of knowledge gaps divided by the maximum possible count: 7
Measured: The outcome was measured immediately following the intervention in the 15-minute baseline survey.
Incidence Rate for Information-seeking Behavior: Control vs. Any Intervention
Incidence rate for Information-seeking behavior is the count of links demanded divided by the maximum possible count: 10
Measured: The outcome was measured immediately following the intervention in the 15-minute baseline survey.
Incidence Rate for Knowledge Gaps by Intervention
Incidence rate for knowledge gaps is the count of knowledge gaps divided by the maximum possible count: 7
Measured: The outcome was measured immediately following the intervention in the 15-minute baseline survey.
Incidence Rate for Information-seeking Behavior by Intervention
Incidence rate for Information-seeking behavior is the count of links demanded divided by the maximum possible count: 10
Measured: The outcome was measured immediately following the intervention in the 15-minute baseline survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start13 May 2020
- Primary completion24 May 2020
- Study completion26 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14,267 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Bureau of Economic Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Stanford University, Yale University, Massachusetts Institute of Technology, Harvard University
- Responsible party
- Principal investigator, Esther Duflo, National Bureau of Economic Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371419
- Sponsor's protocol ID
- 2003000118
- Status last verified
- Jul 2021
- First submitted
- 28 Apr 2020
- Last updated
- 27 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Generally, economists will post code and de-identified data when the findings are published
Publications
Alsan M, Stanford FC, Banerjee A, Breza E, Chandrasekhar AG, Eichmeyer S, Goldsmith-Pinkham P, Ogbu-Nwobodo L, Olken BA, Torres C, Sankar A, Vautrey PL, Duflo E. Comparison of Knowledge and Information-Seeking Behavior After General COVID-19 Public Health Messages and Messages Tailored for Black and Latinx Communities : A Randomized Controlled Trial. Ann Intern Med. 2021 Apr;174(4):484-492. doi: 10.7326/M20-6141. Epub 2020 Dec 21.
PubMed 33347320
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Health Messaging to Underserved Communities
- ClinicalTrials.gov ID
- NCT04371419
- Acronym / sponsor ID
- 2003000118
- Conditions
- Coronavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,267 participants (actual)
- Lead sponsor
- National Bureau of Economic Research, Inc.University, hospital or other
- Collaborators
- Massachusetts General Hospital, Stanford University, Yale University, Massachusetts Institute of Technology, Harvard University
- Study start
- 13 May 2020 (actual)
- Primary completion
- 24 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Posted 27 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent data have shown that covid19 is disproportionately infecting and killing African Americans and Latinx people in the United States. The aim of the study is to determine which messages are most effective at increasing knowledge and changing behaviors that can protect individuals and their communities from the virus. To accomplish this aim, we plan to recruit approximately 20,000 Hispanic and African-American individuals and randomly assign them to videos that vary either the sender or the framing of the message, while providing the relevant public health information.
Detailed description
The following procedures will be followed. The research subjects will participate online.
- Doctors from MGH who express interest in participating will record messages according to our scripts (US Doctors Script African American, US Doctors Script Latinx). They will be instructed to film several different versions each.
- We will recruit a sample of Latinx and African American study participants from across the country through Lucid, an online survey firm that has access to a large subject pool.
- Participants will first read a consent script and give us their informed consent (US Doctors Messaging Consent)
- Participants will then navigate through the following steps
- Brief demographics survey questions (US Doctors Messaging Survey)
- Videos 1 and 2: Introduction, Acknowledgement, Social Distancing (US Doctors Script African American, US Doctors Script Latinx). Individuals in the control group will not see videos.
- Beliefs survey questions (US Doctors Messaging Survey)
- Video 3: Masks (US Doctors Script African American, US Doctors Script Latinx). Again, individuals in the control group will not see a video here.
- Main outcomes survey (US Doctors Messaging Survey)
- Control group is shown a version of all 3 videos at end (US Doctors Script African American, US Doctors Script Latinx).
- The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.
- Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.
- Whether the message includes an acknowledgment of "elephant in the room" issues for each target group: trust in the medical system or fear of deportation.
- Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.
- Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.
- Some individuals in a control group will only see messages after all surveying has been completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Control - CDC - Mask (Control) - Concordant | Experimental | Behavioral: MessagingControl Intro, CDC Social Distancing, Mask Control version delivered by minority doctor of same background as the recipient - other definitions are similar |
| Control - CDC - Mask (Control) - Discordant | Experimental | Behavioral: MessagingControl Intro, CDC Social Distancing, Mask Control version delivered by majority doctor of different background as the recipient - other definitions are similar |
| Control - MGH - Mask (Control) - Concordant | Experimental | Behavioral: MessagingControl Intro, MGH Social Distancing, Mask Control version delivered by concordant doctor |
| Control - MGH - Mask (Control) - Discordant | Experimental | Behavioral: MessagingControl Intro, MGH Social Distancing, Mask Control version delivered by discordant doctor |
| Ack. Discrimination- MGH - Mask (Control) - Concordant | Experimental | Behavioral: MessagingIntroduction Acknowledges past discrimination, MGH doctor talks about Social Distancing, Mask Control all by concordant MD |
| Ack. Discrimination- MGH - Mask (Control) - Discordant | Experimental | Behavioral: MessagingIntroduction Acknowledges past discrimination, MGH doctor talks about Social Distancing, Mask Control all by discordant MD |
| Ack. econ. circumstance- MGH - Mask (Control ) Concordant | Experimental | Behavioral: MessagingIntro econ. circumstance -MGH - Mask (Control ) Concordant |
| Ack. econ. circumstance - MGH - Mask (Control ) Discordant | Experimental | Behavioral: Messaging |
| Control Intro - CDC - Mask (antiStigma) Concordant | Experimental | Behavioral: MessagingControl Intro - CDC - Mask (antiStigma) Concordant messenger |
| Control Intro - CDC - Mask (antiStigma) Discordant | Experimental | Behavioral: MessagingControl Intro - CDC - Mask (antiStigma) discordant messenger |
| Control - MGH - MaskS (antiStigma) Concordant messenger | Experimental | Behavioral: MessagingControl - MGH - MaskS (antiStigma) Concordant sender |
| Control- MGH-MaskS (antiStigma) Discordant messenger | Experimental | Behavioral: MessagingControl - MGH - MaskS (antiStigma) Discordant sender |
| Ack. Discrimination - MGH - MaskS (antiStigma) Concordant | Experimental | Behavioral: MessagingAcknowledge Discrimination - MGH - MaskS (antiStigma) Concordant sender |
| Ack. Discrimination - MGH - MaskS (antiStigma) Discordant | Experimental | Behavioral: MessagingAcknowledge Discrimination - MGH - MaskS (antiStigma) Discordant sender |
| Ack. Econ Hardship- MGH - Mask (antiStigma) Concordant | Experimental | Behavioral: MessagingAcknowledge Econ Hardship- MGH - Mask (antiStigma) Concordant sender |
| Ack. Econ Hardship- MGH - Mask (antiStigma) Discordant | Experimental | Behavioral: MessagingAcknowledge Econ Hardship- MGH - Mask (antiStigma) discordant sender |
| Info later - Pure Control | Placebo comparator | Behavioral: MessagingThis group will not receive the videos but will receive information later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Messagingo The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document. * Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject. * Whether the message includes an acknowledgment of "elephant in the room" issues for each target group: trust in the medical system or fear of deportation. * Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians. * Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey. * Some individuals in a control group will see messages later. | Behavioural | Ack. Discrimination - MGH - MaskS (antiStigma) Concordant, Ack. Discrimination - MGH - MaskS (antiStigma) Discordant, Ack. Discrimination- MGH - Mask (Control) - Concordant, Ack. Discrimination- MGH - Mask (Control) - Discordant, Ack. Econ Hardship- MGH - Mask (antiStigma) Concordant, Ack. Econ Hardship- MGH - Mask (antiStigma) Discordant, Ack. econ. circumstance - MGH - Mask (Control ) Discordant, Ack. econ. circumstance- MGH - Mask (Control ) Concordant, Control - CDC - Mask (Control) - Concordant, Control - CDC - Mask (Control) - Discordant, Control - MGH - Mask (Control) - Concordant, Control - MGH - Mask (Control) - Discordant, Control - MGH - MaskS (antiStigma) Concordant messenger, Control Intro - CDC - Mask (antiStigma) Concordant, Control Intro - CDC - Mask (antiStigma) Discordant, Control- MGH-MaskS (antiStigma) Discordant messenger, Info later - Pure Control |
Primary outcome
Incidence Rate for Knowledge Gaps: Control vs. Any Intervention
Time frame: The outcome was measured immediately following the intervention in the 15-minute baseline survey.
Incidence rate for knowledge gaps is the count of knowledge gaps divided by the maximum possible count: 7
Incidence Rate for Information-seeking Behavior: Control vs. Any Intervention
Time frame: The outcome was measured immediately following the intervention in the 15-minute baseline survey.
Incidence rate for Information-seeking behavior is the count of links demanded divided by the maximum possible count: 10
Incidence Rate for Knowledge Gaps by Intervention
Time frame: The outcome was measured immediately following the intervention in the 15-minute baseline survey.
Incidence rate for knowledge gaps is the count of knowledge gaps divided by the maximum possible count: 7
Incidence Rate for Information-seeking Behavior by Intervention
Time frame: The outcome was measured immediately following the intervention in the 15-minute baseline survey.
Incidence rate for Information-seeking behavior is the count of links demanded divided by the maximum possible count: 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33347320Alsan M, Stanford FC, Banerjee A, Breza E, Chandrasekhar AG, Eichmeyer S, Goldsmith-Pinkham P, Ogbu-Nwobodo L, Olken BA, Torres C, Sankar A, Vautrey PL, Duflo E. Comparison of Knowledge and Information-Seeking Behavior After General COVID-19 Public Health Messages and Messages Tailored for Black and Latinx Communities : A Randomized Controlled Trial. Ann Intern Med. 2021 Apr;174(4):484-492. doi: 10.7326/M20-6141. Epub 2020 Dec 21.
- Individual participant dataSharing planned: Yes. Generally, economists will post code and de-identified data when the findings are published
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Messaging in people with Coronavirus, run by National Bureau of Economic Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Jul 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence Rate for Knowledge Gaps: Control vs. Any Intervention (time frame: The outcome was measured immediately following the intervention in the 15-minute baseline survey.). The study lists 4 primary outcomes in all. 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 NCT04371419, 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 27 Jul 2021.