SARS-CoV2 Infection
Conditions
Keywords
SARS-CoV-2, COVID-19, Health Disparities, Health Communication, Antibodies
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCulturally 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.
BEHAVIORALGeneral SARS-CoV-2 Communication
SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
Sponsors
National Cancer Institute (NCI)
Johns Hopkins University
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Masking description
Participants will be unaware of their assignment to a general versus culturally targeted condition.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* African American or White, 18 or older, and enrolled in the Flint Registry
Exclusion criteria
* All who do not meet inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number (Percentage) of Participants Requested to Participate in Saliva-based SARS-CoV-2 Antibody Testing | Immediately following didactic study portion and health communication randomization on day 1. | 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 Who Requested Saliva-based SARS-CoV-2 Antibody Testing Participated in the Testing. | 8 weeks from the day of consenting to participate in the salivary-based SARS-CoV-2 antibody testing | Number (Percentage) of participants that requested to participate in antibody testing who actually complete antibody testing. |
| SARS-CoV-2 Antibody Testing Attitudes | Immediately following didactic study portion and health communication randomization on day 1. | 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). |
| SARS-CoV-2 Antibody Testing Normative Beliefs | Immediately following didactic study portion and health communication randomization on day 1. | 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). |
| Antibody Testing Perceived Behavioral Control | Immediately following didactic study portion and health communication randomization on day 1. | 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). |
| Antibody Testing Intentions | Immediately following didactic study portion and health communication randomization on day 1. | Sub-measure of Theory of Planned Behavior indicating Intentions to Complete Antibody Testing (Seven point Likert Rating, with higher scores indicating stronger screening Intentions). |
| Antibody Testing Anticipatory Racism | Immediately following didactic study portion and health communication randomization on day 1. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 198 |
| 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 | 128 |
| 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. | 161 |
| Total | 487 |
Baseline characteristics
| Characteristic | White Flint Registry: General | African American Registry: General | African American Registry: Culturally Targeted | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 15 Participants | 19 Participants | 64 Participants |
| Age, Categorical Between 18 and 65 years | 168 Participants | 113 Participants | 142 Participants | 423 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 1 Participants | 1 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 190 Participants | 125 Participants | 159 Participants | 474 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 128 Participants | 161 Participants | 289 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 198 Participants | 0 Participants | 0 Participants | 198 Participants |
| Sex: Female, Male Female | 100 Participants | 73 Participants | 104 Participants | 277 Participants |
| Sex: Female, Male Male | 98 Participants | 55 Participants | 57 Participants | 210 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 198 | 0 / 128 | 0 / 161 |
| other Total, other adverse events | 0 / 198 | 0 / 128 | 0 / 161 |
| serious Total, serious adverse events | 0 / 198 | 0 / 128 | 0 / 161 |
Outcome results
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).
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
Population: All participants for whom Anticipatory Racism measure was successfully recorded immediately following messaging randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Flint Registry: General | Antibody Testing Anticipatory Racism | 1.79 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.25 |
| African American Registry: General | Antibody Testing Anticipatory Racism | 2.93 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.54 |
| African American Registry: Culturally Targeted | Antibody Testing Anticipatory Racism | 2.94 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.57 |
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).
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
Population: All participants for whom Theory of Planned Behavior measure was successfully recorded immediately following messaging randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Flint Registry: General | Antibody Testing Intentions | 4.81 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.52 |
| African American Registry: General | Antibody Testing Intentions | 4.61 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.54 |
| African American Registry: Culturally Targeted | Antibody Testing Intentions | 4.83 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.57 |
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).
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Flint Registry: General | Antibody Testing Perceived Behavioral Control | 5.88 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.19 |
| African American Registry: General | Antibody Testing Perceived Behavioral Control | 5.71 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.29 |
| African American Registry: Culturally Targeted | Antibody Testing Perceived Behavioral Control | 5.76 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.37 |
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.
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
Population: Number (percentage) of participants in each condition who opted to participate in salivary antibody testing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| White Flint Registry: General | Number (Percentage) of Participants Requested to Participate in Saliva-based SARS-CoV-2 Antibody Testing | 175 Participants |
| African American Registry: General | Number (Percentage) of Participants Requested to Participate in Saliva-based SARS-CoV-2 Antibody Testing | 84 Participants |
| African American Registry: Culturally Targeted | Number (Percentage) of Participants Requested to Participate in Saliva-based SARS-CoV-2 Antibody Testing | 121 Participants |
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.
Time frame: 8 weeks from the day of consenting to participate in the salivary-based SARS-CoV-2 antibody testing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| White Flint Registry: General | Number (Percentage) of Participants Who Requested Saliva-based SARS-CoV-2 Antibody Testing Participated in the Testing. | 111 Participants |
| African American Registry: General | Number (Percentage) of Participants Who Requested Saliva-based SARS-CoV-2 Antibody Testing Participated in the Testing. | 55 Participants |
| African American Registry: Culturally Targeted | Number (Percentage) of Participants Who Requested Saliva-based SARS-CoV-2 Antibody Testing Participated in the Testing. | 79 Participants |
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).
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
Population: All participants for whom Theory of Planned Behavior measure was successfully recorded immediately following messaging randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Flint Registry: General | SARS-CoV-2 Antibody Testing Attitudes | 5.91 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.13 |
| African American Registry: General | SARS-CoV-2 Antibody Testing Attitudes | 5.61 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.31 |
| African American Registry: Culturally Targeted | SARS-CoV-2 Antibody Testing Attitudes | 5.71 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.22 |
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).
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
Population: All participants for whom Theory of Planned Behavior measure was successfully recorded immediately following messaging randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Flint Registry: General | SARS-CoV-2 Antibody Testing Normative Beliefs | 4.71 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.38 |
| African American Registry: General | SARS-CoV-2 Antibody Testing Normative Beliefs | 4.69 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.41 |
| African American Registry: Culturally Targeted | SARS-CoV-2 Antibody Testing Normative Beliefs | 4.85 Units on a Scale (Minimum:1, Maximum:7) | Standard Deviation 1.45 |