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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA260469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Johns Hopkins University | OTHER |
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This disparities-focused study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among African Americans residing in Flint, Michigan. This iteration will consider individuals recruited from the Flint Registry and assess willingness to participate in a drive-up saliva sample collection taking place at a central location in Flint, Michigan.
African Americans develop and die from SARS-CoV-2 infection more than any other racial group in the United States, including in majority African American cities such as Flint, Michigan. Addressing these disparities may be aided by SARS-CoV-2 antibody testing. However, African Americans may be reluctant to partake in conventional antibody testing programs due to medical mistrust and experiences with racism. This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing. The central hypothesis is that African-Americans will be more receptive to antibody testing when benefits and limitations are communicated in a culturally effective manner. Our clinical trial aims are to 1) develop and compare effects of a general versus culturally-targeted video about antibody testing on African American and White Flint residents' antibody testing attitudes and uptake; 2) identify and compare effects of a general versus culturally-targeted video on activation of medical mistrust and racism-related cognition among African Americans when considering antibody testing. In collaboration with clinical and community partners, we have prepared and will evaluate general and culturally-targeted video tutorials about SARS-CoV-2 antibody testing. These brief videos will be distributed to the Flint community through the Flint Registry - a highly visible local health resource exchange. We will furnish an opportunity to engage salivary antibody screening and measure willingness to participate. In this study iteration, we will consider willingness to participate in a drive-up saliva sample collection that is taking place at a central location in Flint, Michigan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| White Flint Registry: General | Active Comparator | White participants receive "general consumption" video information about SARS-CoV-2 antibody testing. |
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| African American Registry: General | Active Comparator | African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing. |
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| African American Registry: Culturally Targeted | Experimental | African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally Targeted SARS-CoV-2 Communication | Behavioral | SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans. |
| Measure | Description | Time Frame |
|---|---|---|
| Number (Percentage) of Participants Requested to Participate in Saliva-based SARS-CoV-2 Antibody Testing | Number (Percentage) of participants who respond "yes" to be included in offer to participate in no cost SAR-CoV-2 salivary antibody test. | Immediately following didactic study portion and health communication randomization on day 1. |
| Number (Percentage) of Participants Who Requested Saliva-based SARS-CoV-2 Antibody Testing Participated in the Testing. | Number (Percentage) of participants that requested to participate in antibody testing who actually complete antibody testing. | 8 weeks from the day of consenting to participate in the salivary-based SARS-CoV-2 antibody testing |
| SARS-CoV-2 Antibody Testing Attitudes | Submeasure of Theory of Planned Behavior Indicating extent of a favorable attitude SARS-CoV-2 towards antibody testing (Seven point Likert Rating, with higher scores indicating more favorable Attitudes). | Immediately following didactic study portion and health communication randomization on day 1. |
| SARS-CoV-2 Antibody Testing Normative Beliefs | Sub-measure of Theory of Planned Behavior Indicating extent to which believes other people are favorable towards SARS-CoV-2 towards antibody testing (Seven point Likert Rating, with higher scores indicating stronger Normative Beliefs). | Immediately following didactic study portion and health communication randomization on day 1. |
| Antibody Testing Perceived Behavioral Control | Sub-measure of Theory of Planned Behavior Indicating Self Efficacy to Complete Antibody Testing (Seven point Likert Rating, with higher scores indicating greater Perceived Behavioral Control). | Immediately following didactic study portion and health communication randomization on day 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flint Journal Building | Flint | Michigan | 48502 | United States |
Data will be made available per requirements and sharing structures established by NCI "SeroNet" initiative.
Upon Study Completion
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| ID | Title | Description |
|---|---|---|
| FG000 | White Flint Registry: General | White participants receive "general consumption" video information about SARS-CoV-2 antibody testing. General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information |
| FG001 | African American Registry: General | African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing. General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information |
| FG002 | African American Registry: Culturally Targeted | African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing. Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | White Flint Registry: General | White participants receive "general consumption" video information about SARS-CoV-2 antibody testing. General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information |
| BG001 | African American Registry: General |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number (Percentage) of Participants Requested to Participate in Saliva-based SARS-CoV-2 Antibody Testing | Number (Percentage) of participants who respond "yes" to be included in offer to participate in no cost SAR-CoV-2 salivary antibody test. | Number (percentage) of participants in each condition who opted to participate in salivary antibody testing. | Posted | Count of Participants | Participants | Immediately following didactic study portion and health communication randomization on day 1. |
|
8 weeks.
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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 | White Flint Registry: General | White participants receive "general consumption" video information about SARS-CoV-2 antibody testing. General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Todd Lucas | Michigan State University | 810-600-5629 | lucastod@msu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2022 | May 29, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2024 | May 29, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Design is partial factorial. All white participants and half of African American participants will receive general video education/messaging. Half of African American participants will be assigned to an intervention condition that includes culturally-targeted information about SARS-CoV-2 antibody testing.
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Participants will be unaware of their assignment to a general versus culturally targeted condition.
| General SARS-CoV-2 Communication | Behavioral | SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information |
|
| Antibody Testing Intentions | Sub-measure of Theory of Planned Behavior indicating Intentions to Complete Antibody Testing (Seven point Likert Rating, with higher scores indicating stronger screening Intentions). | Immediately following didactic study portion and health communication randomization on day 1. |
| Antibody Testing Anticipatory Racism | Extent to which participants believe that racism-related factors would diminish the value of SARS-CoV-2 antibody testing for self (Seven-point Likert rating, with higher scores indicating greater Anticipatory Racism). | Immediately following didactic study portion and health communication randomization on day 1. |
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing. General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information |
| BG002 | African American Registry: Culturally Targeted | African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing. Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| African American Registry: General |
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing. General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information |
| OG002 | African American Registry: Culturally Targeted | African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing. Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans. |
|
|
| Primary | Number (Percentage) of Participants Who Requested Saliva-based SARS-CoV-2 Antibody Testing Participated in the Testing. | Number (Percentage) of participants that requested to participate in antibody testing who actually complete antibody testing. | Posted | Count of Participants | Participants | 8 weeks from the day of consenting to participate in the salivary-based SARS-CoV-2 antibody testing |
|
|
|
| Primary | SARS-CoV-2 Antibody Testing Attitudes | Submeasure of Theory of Planned Behavior Indicating extent of a favorable attitude SARS-CoV-2 towards antibody testing (Seven point Likert Rating, with higher scores indicating more favorable Attitudes). | All participants for whom Theory of Planned Behavior measure was successfully recorded immediately following messaging randomization. | Posted | Mean | Standard Deviation | Units on a Scale (Minimum:1, Maximum:7) | Immediately following didactic study portion and health communication randomization on day 1. |
|
|
|
| Primary | SARS-CoV-2 Antibody Testing Normative Beliefs | Sub-measure of Theory of Planned Behavior Indicating extent to which believes other people are favorable towards SARS-CoV-2 towards antibody testing (Seven point Likert Rating, with higher scores indicating stronger Normative Beliefs). | All participants for whom Theory of Planned Behavior measure was successfully recorded immediately following messaging randomization. | Posted | Mean | Standard Deviation | Units on a Scale (Minimum:1, Maximum:7) | Immediately following didactic study portion and health communication randomization on day 1. |
|
|
|
| Primary | Antibody Testing Perceived Behavioral Control | Sub-measure of Theory of Planned Behavior Indicating Self Efficacy to Complete Antibody Testing (Seven point Likert Rating, with higher scores indicating greater Perceived Behavioral Control). | Posted | Mean | Standard Deviation | Units on a Scale (Minimum:1, Maximum:7) | Immediately following didactic study portion and health communication randomization on day 1. |
|
|
|
| Primary | Antibody Testing Intentions | Sub-measure of Theory of Planned Behavior indicating Intentions to Complete Antibody Testing (Seven point Likert Rating, with higher scores indicating stronger screening Intentions). | All participants for whom Theory of Planned Behavior measure was successfully recorded immediately following messaging randomization. | Posted | Mean | Standard Deviation | Units on a Scale (Minimum:1, Maximum:7) | Immediately following didactic study portion and health communication randomization on day 1. |
|
|
|
| Primary | Antibody Testing Anticipatory Racism | Extent to which participants believe that racism-related factors would diminish the value of SARS-CoV-2 antibody testing for self (Seven-point Likert rating, with higher scores indicating greater Anticipatory Racism). | All participants for whom Anticipatory Racism measure was successfully recorded immediately following messaging randomization. | Posted | Mean | Standard Deviation | Units on a Scale (Minimum:1, Maximum:7) | Immediately following didactic study portion and health communication randomization on day 1. |
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| 0 |
| 198 |
| 0 |
| 198 |
| 0 |
| 198 |
| EG001 | African American Registry: General | African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing. General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information | 0 | 128 | 0 | 128 | 0 | 128 |
| EG002 | African American Registry: Culturally Targeted | African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing. Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans. | 0 | 161 | 0 | 161 | 0 | 161 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |