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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
| Massachusetts Institute of Technology | OTHER |
| National Institute on Aging (NIA) | NIH |
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The aim of the study is to identify what sender/signal combinations are most persuasive in encouraging low socioeconomic males living in the U.S. to take-up seasonal flu vaccination. The investigators plan to recruit male subjects and randomly assign them to four persuasion treatments: three of which vary dimensions of the sender of a medical recommendation (racial concordance and authority treatments) and one which varies the signal (standard vs. empathetic). Specifically, the investigators will show subjects videos of either Black or white actors/actresses providing scripted information on the flu vaccination. The investigators will randomize the race of the sender and if the subject is Black, also randomize the authority of the sender, with the actor portraying either a doctor or a layperson. In addition, the investigators will vary the script used in the experiment between one that acknowledges past injustices (indicated as an empathetic script hereafter) and one that does not (indicated as a standard script hereafter). The investigators will provide subjects a free flu shot coupon and elicit the price at which subjects would be willing to give up this coupon for a cash reward. Lastly, in light of the relevance of vaccination take-up in combating COVID-19 pandemic, the investigators will assess demand for information about a COVID-19 vaccine, with subjects invited to receive results of a safety and efficacy review from a trusted or standard source. The design requires the collection of baseline and endline surveys combined with administrative data from pharmacies about coupon redemption. The primary outcomes of interest are posterior beliefs about seasonal flu vaccination, demand and willingness-to-pay (WTP) for a free flu shot coupon, redemption of the coupon, and demand for information about a COVID-19 vaccine.
The investigators will recruit approximately 3350 African-American or Caucasian adult males with a high-school diploma or less. A pilot study, which ran during the 2019-20 flu season, recruited approximately 850 subjects, and a planned scale-up will recruit an additional 2500 subjects during the 2020-21 flu season. The investigators will oversample African American individuals, emphasizing low-income and minority men because these characteristics are correlated with lower relative take-up of flu vaccination. After informed consent is obtained, subjects will be asked about sociodemographic information (age, education, income and marital status), healthcare experience and past medical history, knowledge and beliefs about flu vaccination, and location of the nearest pharmacy. The investigators will then randomly assign the adult male subjects to videos which contain one of Black or white actors playing the role of either a doctor or a layperson as well as different scripts. The content of the infomercial will be the safety and effectiveness of adult seasonal flu vaccination. After the video, the investigators will obtain information on beliefs regarding vaccination, feedback on the video, attention to the video and willingness-to-pay for a flu shot coupon. The final baseline module will consist of a randomly assigned invitation to receive the results of an upcoming review of a COVID-19 vaccine, with subjects assigned to receive information from a trusted or standard source. The investigators will track flu coupon redemption, which is redeemable at most pharmacies nationwide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Black R/Race C/Doctor/Standard Script | Experimental | Video which contains a racially concordant actor playing a doctor and reading a standard script. The receiver of the message will be Black. |
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| Black R/Race C/Layperson/Standard Script | Experimental | Video which contains a racially concordant actor playing a layperson and reading a standard script. The receiver of the message will be Black. |
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| Black R/Race D/Doctor/Standard Script | Experimental | Video which contains a racially discordant actor playing a doctor and reading a standard script. The receiver of the message will be Black. |
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| Black R/Race D/Doctor/Acknowledgement Script | Experimental | Video which contains a racially discordant actor playing a doctor and reading an acknowledgement script. The receiver of the message will be Black. |
|
| White R/Race C/Doctor/Standard Script | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video about safety and effectiveness of adult seasonal flu vaccination | Behavioral | The investigators will show subjects videos of either Black or white male actors providing scripted information on the flu vaccination. The content of the video will be the safety and effectiveness of adult seasonal flu vaccination. The videos contain one of Black or white actors playing the role of either a doctor or a layperson as well as different scripts. |
| Measure | Description | Time Frame |
|---|---|---|
| Rating of Sender | This is an inverse-covariance-weighted index comprised of responses to survey questions regarding:
It is standardized to a mean of 0 and standard deviation of 1. Scores less than 0 indicate lower ratings of the sender rated by participants in Arm A (described in each arm/group description) compared to the rating rated by participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate higher ratings of the sender by Arm A compared to by Arm B. For example, an index score of .18 indicates that participants in Arm A rate the sender 0.18 index (in standard deviation units) higher than those in Arm B. | This outcome was assessed during Baseline survey, which took approximately 20 minutes. |
| Rating of Signal | This is an inverse-covariance-weighted index comprised of responses to survey questions on:
It is standardized to a mean of 0 and standard deviation of 1. An index score of 0 is equal to the mean. Scores less than 0 indicate lower ratings of the signal rated by participants in Arm A (described in each arm/group description) compared to the rating rated by participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate higher ratings of the signal by Arm A compared to by Arm B. For example, an index score of 0.14 indicates that participants in Arm A rate the signal 0.14 index (in standard deviation units) higher than those in Arm B. | This outcome was assessed during Baseline survey, which took approximately 20 minutes. |
| Signal Content Recall | This is an inverse-covariance-weighted index comprised of responses to survey questions on:
It is standardized to a mean of 0 and standard deviation of 1. An index score of 0 is equal to the mean. Scores less than 0 indicate lower level of recalling signal content among participants in Arm A (described in each arm/group description) compared to the level among participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate a higher level of recalling signal content among participants in Arm A compared to those in Arm B. For example, an index score of 0.02 indicates that participants in Arm A recall signal content 0.02 index (in standard deviation units) higher than those in Arm B. |
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Inclusion Criteria:
Exclusion Criteria:
The investigators will only recruit male subjects.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard University | Cambridge | Massachusetts | 02138 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Black Participant-Concordant Sender-Expert Sender-Standard Signal | Black participants who are assigned to a concordant-exper sender delivering a standard signal. |
| FG001 | Black Participant-Concordant Sender-Lay Sender-Standard Signal | Black participants who are assigned to a concordant-lay sender delivering a standard signal. |
| FG002 | Black Participant-Discordant Sender-Expert Sender-Standard Signal | Black participants who are assigned to a discordant-exper sender delivering a standard signal. |
| FG003 | Black Participant-Discordant Sender-Expert Sender-Acknowledgement Signal | Black participants who are assigned to a discordant-exper sender delivering a acknowledgement signal. |
| FG004 | White Participant-Concordant Sender-Expert Sender-Standard Signal | White participants who are assigned to a concordant-exper sender delivering a standard signal. |
| FG005 | White Participant-Discordant Sender-Expert Sender-Standard Signal | White participants who are assigned to a discordant-exper sender delivering a standard signal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who were eligible to participate in and completed the baseline survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Black Participant-Concordant Sender-Expert Sender-Standard Signal | Black participants who are assigned to a concordant-exper sender delivering a standard signal. |
| BG001 | Black Participant-Concordant Sender-Lay Sender-Standard Signal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rating of Sender | This is an inverse-covariance-weighted index comprised of responses to survey questions regarding:
It is standardized to a mean of 0 and standard deviation of 1. Scores less than 0 indicate lower ratings of the sender rated by participants in Arm A (described in each arm/group description) compared to the rating rated by participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate higher ratings of the sender by Arm A compared to by Arm B. For example, an index score of .18 indicates that participants in Arm A rate the sender 0.18 index (in standard deviation units) higher than those in Arm B. | Arms/Groups are combined as described in each arm/group description in order to test hypotheses prespecified in the analysis plan as well as to measure the effect of the given intervention on the outcome among the group of participants in Arm A compared to Arm B. The intervention and Arms A and B are described in each arm/group description. | Posted | Number | 95% Confidence Interval | index | This outcome was assessed during Baseline survey, which took approximately 20 minutes. |
6.5 months (3 months during the 2019 to 2020 flu season and 3.5 months during the 2020-2021 flu season)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Black Participant-Concordant Sender-Expert Sender-Standard Signal | Black participants who are assigned to a concordant-exper sender delivering a standard signal. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marcella Alsan | Harvard University | 617-496-1770 | marcella_alsan@hks.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2020 | May 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Video which contains a racially concordant actor playing a doctor and reading a standard script. The receiver of the message will be White. |
|
| White R/Race D/Doctor/Standard Script | Experimental | Video which contains a racially discordant actor playing a doctor and reading a standard script. The receiver of the message will be White. |
|
|
| This outcome will be assessed during Baseline survey, which takes approximately 20 minutes. |
| Safety Beliefs | This is an inverse-covariance-weighted index comprised of:
It is standardized to a mean of 0 and standard deviation of 1. An index score of 0 is equal to the mean. Scores less than 0 indicate a lower level of beliefs in the safety of flu vaccine among participants in Arm A (described in each arm/group description) compared to the level among participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate a higher level of beliefs among participants in Arm A compared to those in Arm B. For example, an index score of -0.1 indicates that participants in Arm A hold such beliefs 0.1 index (in standard deviation units) lower than those in Arm B. | This outcome will be assessed during Baseline survey, which takes approximately 20 minutes. |
| Coupon Interest | This is an inverse-covariance-weighted index comprised of revealed preference measures of demand for a free flu shot coupon:
It is standardized to a mean of 0 and standard deviation of 1. An index score of 0 is equal to the mean. Scores less than 0 indicate a lower level of interest in a free flu shot coupon distributed after survey completion among participants in Arm A (described in each arm/group description) compared to the level among participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate a higher level of interest among participants in Arm A compared to those in Arm B. For example, an index score of -0.01 indicates that participants in Arm A hold such interest -0.01 index (in standard deviation units) higher than those in Arm B. | This outcome was assessed during Baseline survey, which took approximately 20 minutes. |
| (Posterior) Flu Vaccine Intent | This is the respondent's likelihood to receive the flu vaccine before the end of the flu season. This was elicited on an 11-point Likert scale (0 extremely unwilling, 10 extremely willing) after the video message treatment. We re-scaled this outcome to have a scale of 0 to 1. The reported results of the outcome compare participants in Arm A and Arm B (described in each arm/group description). For example, an intent of 0.03 indicates that participants in Arm A are 0.03 units on a scale more likely to intent to take up the flu vaccine compared to those in Arm B. | This outcome was assessed after the video treatment during Baseline survey, which took approximately 20 minutes. |
| COVID-19 Vaccine Intent | This is the respondent's likelihood to take up the COVID-19 vaccine if made available free of charge. This was elicited on an 11-point Likert scale (0 extremely unwilling, 10 extremely willing) after the video message treatment. We re-scaled this outcome to have a scale of 0 to 1. The reported results of the outcome compare participants in Arm A and Arm B (described in each arm/group description). For example, an intent of 0.04 indicates that participants in Arm A are 0.04 units on a scale more likely to intent to take up the COVID-19 vaccine compared to those in Arm B. | This outcome was assessed after the video treatment during Baseline survey, which took approximately 20 minutes. |
| Flu Vaccine Take-up | This is respondents' self-report in the follow-up survey on whether they or their family members had received the flu shot or redeemed the coupon since the intervention. The reported results of the outcome compare participants in Arm A and Arm B (described in each arm/group description). For example, 15.0 percentage points indicate that participants in Arm A are more likely to report that they and/or another household member received the flu vaccine by 15.p percentage points compared to those in Arm B. | This outcome was assessed during the follow-up survey which was conducted at least two weeks after the initial baseline survey. |
Black participants who are assigned to a concordant-lay sender delivering a standard signal.
| BG002 | Black Participant-Discordant Sender-Expert Sender-Standard Signal | Black participants who are assigned to a discordant-exper sender delivering a standard signal. |
| BG003 | Black Participant-Discordant Sender-Expert Sender-Acknowledgement Signal | Black participants who are assigned to a discordant-exper sender delivering a acknowledgement signal. |
| BG004 | White Participant-Concordant Sender-Expert Sender-Standard Signal | White participants who are assigned to a concordant-exper sender delivering a standard signal. |
| BG005 | White Participant-Discordant Sender-Expert Sender-Standard Signal | White participants who are assigned to a discordant-exper sender delivering a standard signal. |
| BG006 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| High School | Count of Participants | Participants |
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| Married | Count of Participants | Participants |
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| Insured | Count of Participants | Participants |
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| Subjective Health Status | Subjective Health Status is measured on a 5-point Likert scale (where 1 is poor and 5 is excellent). | Mean | Standard Deviation | units on a scale |
|
| Subjective Flu Shot Cost | Mean | Standard Deviation | dollar |
|
| Has Primary Care Provider | Count of Participants | Participants |
|
| (Prior) Flu Vaccine Intent | Flu vaccine intent is measured on a scale of 0 (extremely unwilling) to 10 (extremely willing). | Mean | Standard Deviation | units on a scale |
|
| (Prior) Likelihood of Contracting Flu | Likelihood of contracting flu is measured on a scale of 0 (extremely unlikely) to 10 (extremely likely). | Mean | Standard Deviation | units on a scale |
|
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|
| Primary | Rating of Signal | This is an inverse-covariance-weighted index comprised of responses to survey questions on:
It is standardized to a mean of 0 and standard deviation of 1. An index score of 0 is equal to the mean. Scores less than 0 indicate lower ratings of the signal rated by participants in Arm A (described in each arm/group description) compared to the rating rated by participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate higher ratings of the signal by Arm A compared to by Arm B. For example, an index score of 0.14 indicates that participants in Arm A rate the signal 0.14 index (in standard deviation units) higher than those in Arm B. | Arms/Groups are combined as described in each arm/group description in order to test hypotheses prespecified in the analysis plan as well as to measure the effect of the given intervention on the outcome among the group of participants in Arm A compared to Arm B. The intervention and Arms A and B are described in each arm/group description. | Posted | Number | 95% Confidence Interval | index | This outcome was assessed during Baseline survey, which took approximately 20 minutes. |
|
|
|
| Primary | Signal Content Recall | This is an inverse-covariance-weighted index comprised of responses to survey questions on:
It is standardized to a mean of 0 and standard deviation of 1. An index score of 0 is equal to the mean. Scores less than 0 indicate lower level of recalling signal content among participants in Arm A (described in each arm/group description) compared to the level among participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate a higher level of recalling signal content among participants in Arm A compared to those in Arm B. For example, an index score of 0.02 indicates that participants in Arm A recall signal content 0.02 index (in standard deviation units) higher than those in Arm B. | Arms/Groups are combined as described in each arm/group description in order to test hypotheses prespecified in the analysis plan as well as to measure the effect of the given intervention on the outcome among the group of participants in Arm A compared to Arm B. The intervention and Arms A and B are described in each arm/group description. | Posted | Number | 95% Confidence Interval | index | This outcome will be assessed during Baseline survey, which takes approximately 20 minutes. |
|
|
|
| Primary | Safety Beliefs | This is an inverse-covariance-weighted index comprised of:
It is standardized to a mean of 0 and standard deviation of 1. An index score of 0 is equal to the mean. Scores less than 0 indicate a lower level of beliefs in the safety of flu vaccine among participants in Arm A (described in each arm/group description) compared to the level among participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate a higher level of beliefs among participants in Arm A compared to those in Arm B. For example, an index score of -0.1 indicates that participants in Arm A hold such beliefs 0.1 index (in standard deviation units) lower than those in Arm B. | Arms/Groups are combined as described in each arm/group description in order to test hypotheses prespecified in the analysis plan as well as to measure the effect of the given intervention on the outcome among the group of participants in Arm A compared to Arm B. The intervention and Arms A and B are described in each arm/group description. | Posted | Number | 95% Confidence Interval | index | This outcome will be assessed during Baseline survey, which takes approximately 20 minutes. |
|
|
|
| Primary | Coupon Interest | This is an inverse-covariance-weighted index comprised of revealed preference measures of demand for a free flu shot coupon:
It is standardized to a mean of 0 and standard deviation of 1. An index score of 0 is equal to the mean. Scores less than 0 indicate a lower level of interest in a free flu shot coupon distributed after survey completion among participants in Arm A (described in each arm/group description) compared to the level among participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate a higher level of interest among participants in Arm A compared to those in Arm B. For example, an index score of -0.01 indicates that participants in Arm A hold such interest -0.01 index (in standard deviation units) higher than those in Arm B. | Arms/Groups are combined as described in each arm/group description in order to test hypotheses prespecified in the analysis plan as well as to measure the effect of the given intervention on the outcome among the group of participants in Arm A compared to Arm B. The intervention and Arms A and B are described in each arm/group description. | Posted | Number | 95% Confidence Interval | index | This outcome was assessed during Baseline survey, which took approximately 20 minutes. |
|
|
|
| Primary | (Posterior) Flu Vaccine Intent | This is the respondent's likelihood to receive the flu vaccine before the end of the flu season. This was elicited on an 11-point Likert scale (0 extremely unwilling, 10 extremely willing) after the video message treatment. We re-scaled this outcome to have a scale of 0 to 1. The reported results of the outcome compare participants in Arm A and Arm B (described in each arm/group description). For example, an intent of 0.03 indicates that participants in Arm A are 0.03 units on a scale more likely to intent to take up the flu vaccine compared to those in Arm B. | Arms/Groups are combined as described in each arm/group description in order to test hypotheses prespecified in the analysis plan as well as to measure the effect of the given intervention on the outcome among the group of participants in Arm A compared to Arm B. The intervention and Arms A and B are described in each arm/group description. | Posted | Number | 95% Confidence Interval | units on a scale | This outcome was assessed after the video treatment during Baseline survey, which took approximately 20 minutes. |
|
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|
| Primary | COVID-19 Vaccine Intent | This is the respondent's likelihood to take up the COVID-19 vaccine if made available free of charge. This was elicited on an 11-point Likert scale (0 extremely unwilling, 10 extremely willing) after the video message treatment. We re-scaled this outcome to have a scale of 0 to 1. The reported results of the outcome compare participants in Arm A and Arm B (described in each arm/group description). For example, an intent of 0.04 indicates that participants in Arm A are 0.04 units on a scale more likely to intent to take up the COVID-19 vaccine compared to those in Arm B. | Arms/Groups are combined as described in each arm/group description in order to test hypotheses prespecified in the analysis plan as well as to measure the effect of the given intervention on the outcome among the group of participants in Arm A compared to Arm B. The intervention and Arms A and B are described in each arm/group description. | Posted | Number | 95% Confidence Interval | units on a scale | This outcome was assessed after the video treatment during Baseline survey, which took approximately 20 minutes. |
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| Primary | Flu Vaccine Take-up | This is respondents' self-report in the follow-up survey on whether they or their family members had received the flu shot or redeemed the coupon since the intervention. The reported results of the outcome compare participants in Arm A and Arm B (described in each arm/group description). For example, 15.0 percentage points indicate that participants in Arm A are more likely to report that they and/or another household member received the flu vaccine by 15.p percentage points compared to those in Arm B. | Arms/Groups are combined as described in each arm/group description in order to test hypotheses prespecified in the analysis plan as well as to measure the effect of the given intervention on the outcome among the group of participants in Arm A compared to Arm B. The intervention and Arms A and B are described in each arm/group description. | Posted | Number | 95% Confidence Interval | percentage points | This outcome was assessed during the follow-up survey which was conducted at least two weeks after the initial baseline survey. |
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| 0 |
| 479 |
| 0 |
| 479 |
| 0 |
| 479 |
| EG001 | Black Participant-Concordant Sender-Lay Sender-Standard Signal | Black participants who are assigned to a concordant-lay sender delivering a standard signal. | 0 | 496 | 0 | 496 | 0 | 496 |
| EG002 | Black Participant-Discordant Sender-Expert Sender-Standard Signal | Black participants who are assigned to a discordant-exper sender delivering a standard signal. | 0 | 478 | 0 | 478 | 0 | 478 |
| EG003 | Black Participant-Discordant Sender-Expert Sender-Acknowledgement Signal | Black participants who are assigned to a discordant-exper sender delivering a acknowledgement signal. | 0 | 485 | 0 | 485 | 0 | 485 |
| EG004 | White Participant-Concordant Sender-Expert Sender-Standard Signal | White participants who are assigned to a concordant-exper sender delivering a standard signal. | 0 | 649 | 0 | 649 | 0 | 649 |
| EG005 | White Participant-Discordant Sender-Expert Sender-Standard Signal | White participants who are assigned to a discordant-exper sender delivering a standard signal. | 0 | 658 | 0 | 658 | 0 | 658 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |