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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • JPAL North America

    Cambridge, Massachusetts, 02138

Other trials in United States

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.

  1. 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.
  2. 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.
  3. Participants will first read a consent script and give us their informed consent (US Doctors Messaging Consent)
  4. Participants will then navigate through the following steps
  5. Brief demographics survey questions (US Doctors Messaging Survey)
  6. 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.
  7. Beliefs survey questions (US Doctors Messaging Survey)
  8. Video 3: Masks (US Doctors Script African American, US Doctors Script Latinx). Again, individuals in the control group will not see a video here.
  9. Main outcomes survey (US Doctors Messaging Survey)
  10. Control group is shown a version of all 3 videos at end (US Doctors Script African American, US Doctors Script Latinx).
  11. 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.
  12. Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.
  13. 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.
  14. Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.
  15. 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.
  16. 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 groups in NCT04371419
Study groupRoleWhat they receive
Control - CDC - Mask (Control) - ConcordantExperimentalControl 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) - DiscordantExperimentalControl 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) - ConcordantExperimentalControl Intro, MGH Social Distancing, Mask Control version delivered by concordant doctor
Receives: Behavioral: Messaging
Control - MGH - Mask (Control) - DiscordantExperimentalControl Intro, MGH Social Distancing, Mask Control version delivered by discordant doctor
Receives: Behavioral: Messaging
Ack. Discrimination- MGH - Mask (Control) - ConcordantExperimentalIntroduction Acknowledges past discrimination, MGH doctor talks about Social Distancing, Mask Control all by concordant MD
Receives: Behavioral: Messaging
Ack. Discrimination- MGH - Mask (Control) - DiscordantExperimentalIntroduction Acknowledges past discrimination, MGH doctor talks about Social Distancing, Mask Control all by discordant MD
Receives: Behavioral: Messaging
Ack. econ. circumstance- MGH - Mask (Control ) ConcordantExperimentalIntro econ. circumstance -MGH - Mask (Control ) Concordant
Receives: Behavioral: Messaging
Ack. econ. circumstance - MGH - Mask (Control ) DiscordantExperimentalNot described
Receives: Behavioral: Messaging
Control Intro - CDC - Mask (antiStigma) ConcordantExperimentalControl Intro - CDC - Mask (antiStigma) Concordant messenger
Receives: Behavioral: Messaging
Control Intro - CDC - Mask (antiStigma) DiscordantExperimentalControl Intro - CDC - Mask (antiStigma) discordant messenger
Receives: Behavioral: Messaging
Control - MGH - MaskS (antiStigma) Concordant messengerExperimentalControl - MGH - MaskS (antiStigma) Concordant sender
Receives: Behavioral: Messaging
Control- MGH-MaskS (antiStigma) Discordant messengerExperimentalControl - MGH - MaskS (antiStigma) Discordant sender
Receives: Behavioral: Messaging
Ack. Discrimination - MGH - MaskS (antiStigma) ConcordantExperimentalAcknowledge Discrimination - MGH - MaskS (antiStigma) Concordant sender
Receives: Behavioral: Messaging
Ack. Discrimination - MGH - MaskS (antiStigma) DiscordantExperimentalAcknowledge Discrimination - MGH - MaskS (antiStigma) Discordant sender
Receives: Behavioral: Messaging
Ack. Econ Hardship- MGH - Mask (antiStigma) ConcordantExperimentalAcknowledge Econ Hardship- MGH - Mask (antiStigma) Concordant sender
Receives: Behavioral: Messaging
Ack. Econ Hardship- MGH - Mask (antiStigma) DiscordantExperimentalAcknowledge Econ Hardship- MGH - Mask (antiStigma) discordant sender
Receives: Behavioral: Messaging
Info later - Pure ControlPlacebo comparatorThis 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  1. First posted1 May 2020
  2. Study start13 May 2020
  3. Primary completion24 May 2020
  4. Study completion26 May 2020

Resources

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)
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
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

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.

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