- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04371419
COVID-19 Health Messaging to Underserved Communities
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Cambridge, Massachusetts, United States, 02138
- JPAL North America
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control - CDC - Mask (Control) - Concordant
Control Intro, CDC Social Distancing, Mask Control version delivered by minority doctor of same background as the recipient - other definitions are similar
|
o 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.
|
Experimental: Control - CDC - Mask (Control) - Discordant
Control Intro, CDC Social Distancing, Mask Control version delivered by majority doctor of different background as the recipient - other definitions are similar
|
o 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.
|
Experimental: Control - MGH - Mask (Control) - Concordant
Control Intro, MGH Social Distancing, Mask Control version delivered by concordant doctor
|
o 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.
|
Experimental: Control - MGH - Mask (Control) - Discordant
Control Intro, MGH Social Distancing, Mask Control version delivered by discordant doctor
|
o 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.
|
Experimental: Ack. Discrimination- MGH - Mask (Control) - Concordant
Introduction Acknowledges past discrimination, MGH doctor talks about Social Distancing, Mask Control all by concordant MD
|
o 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.
|
Experimental: Ack. Discrimination- MGH - Mask (Control) - Discordant
Introduction Acknowledges past discrimination, MGH doctor talks about Social Distancing, Mask Control all by discordant MD
|
o 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.
|
Experimental: Ack. econ. circumstance- MGH - Mask (Control ) Concordant
Intro econ.
circumstance -MGH - Mask (Control ) Concordant
|
o 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.
|
Experimental: Ack. econ. circumstance - MGH - Mask (Control ) Discordant
|
o 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.
|
Experimental: Control Intro - CDC - Mask (antiStigma) Concordant
Control Intro - CDC - Mask (antiStigma) Concordant messenger
|
o 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.
|
Experimental: Control Intro - CDC - Mask (antiStigma) Discordant
Control Intro - CDC - Mask (antiStigma) discordant messenger
|
o 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.
|
Experimental: Control - MGH - MaskS (antiStigma) Concordant messenger
Control - MGH - MaskS (antiStigma) Concordant sender
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o 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.
|
Experimental: Control- MGH-MaskS (antiStigma) Discordant messenger
Control - MGH - MaskS (antiStigma) Discordant sender
|
o 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.
|
Experimental: Ack. Discrimination - MGH - MaskS (antiStigma) Concordant
Acknowledge Discrimination - MGH - MaskS (antiStigma) Concordant sender
|
o 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.
|
Experimental: Ack. Discrimination - MGH - MaskS (antiStigma) Discordant
Acknowledge Discrimination - MGH - MaskS (antiStigma) Discordant sender
|
o 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.
|
Experimental: Ack. Econ Hardship- MGH - Mask (antiStigma) Concordant
Acknowledge Econ Hardship- MGH - Mask (antiStigma) Concordant sender
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o 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.
|
Experimental: Ack. Econ Hardship- MGH - Mask (antiStigma) Discordant
Acknowledge Econ Hardship- MGH - Mask (antiStigma) discordant sender
|
o 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.
|
Placebo Comparator: Info later - Pure Control
This group will not receive the videos but will receive information later.
|
o 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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The outcome was measured immediately following the intervention in the 15-minute baseline survey.
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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
|
The outcome was measured immediately following the intervention in the 15-minute baseline survey.
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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
|
The outcome was measured immediately following the intervention in the 15-minute baseline survey.
|
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
|
The outcome was measured immediately following the intervention in the 15-minute baseline survey.
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003000118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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