Culturally-Targeted COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake
Primary Purpose
SARS-CoV2 Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Culturally Targeted SARS-CoV-2 Communication
General SARS-CoV-2 Communication
Sponsored by

About this trial
This is an interventional screening trial for SARS-CoV2 Infection focused on measuring SARS-CoV-2, COVID-19, Health Disparities, Health Communication, Antibodies
Eligibility Criteria
Inclusion Criteria:
- African American or White, 18 or older, and enrolled in the Flint Registry
Exclusion Criteria:
- All who do not meet inclusion criteria.
Sites / Locations
- Flint Journal Building
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
White Flint Registry: General
African American Registry: General
African American Registry: Culturally Targeted
Arm Description
White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.
Outcomes
Primary Outcome Measures
Salivary Kit Request
Does participant request to receive a salivary kit from the study team? (yes-no)
Salivary Kit Completion
Do participants who request salivary kits use/return them? (yes-no)
Theory of Planned Behavior Antibody Testing Outcomes
Self-report measures of antibody testing attitudes, norms, perceived control, intentions to be screened are each adapted from published research (Lucas et al., 2021). These items are constructed following recommended procedures to ensure construct validity and adequate behavioral specificity (Fishbein & Ajzen, 2011). All items use Likert-type scales that range from 1 (strongly agree) to 7 (strongly disagree).
Anticipatory Racism
Adapted from published research (Lucas et al., 2021), all participants respond to questions that asked whether they believe racism would impact the benefits they could experience from obtaining antibody testing. Participants will then respond to three questions that ask, "In some way, my obtaining CRC screening would be impacted by racism," "Racism would undermine the value of CRC screening for me." and "Racism would negatively impact the accuracy of my CRC screening. Responses are collected using a 7-point Likert-type scale that ranged from 1 (strongly agree) to 7 (strongly disagree).
Secondary Outcome Measures
Full Information
NCT ID
NCT04957082
First Posted
July 6, 2021
Last Updated
October 10, 2023
Sponsor
Michigan State University
Collaborators
National Cancer Institute (NCI), Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT04957082
Brief Title
Culturally-Targeted COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake
Official Title
Culturally-targeted Communication to Promote SARS-CoV-2 Antibody Testing in Saliva: Enabling Evaluation of Inflammatory Pathways in COVID-19 Racial Disparities
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
December 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
National Cancer Institute (NCI), Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 Infection
Keywords
SARS-CoV-2, COVID-19, Health Disparities, Health Communication, Antibodies
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
Participant
Masking Description
Participants will be unaware of their assignment to a general versus culturally targeted condition.
Allocation
Randomized
Enrollment
525 (Actual)
8. Arms, Groups, and Interventions
Arm Title
White Flint Registry: General
Arm Type
Active Comparator
Arm Description
White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
Arm Title
African American Registry: General
Arm Type
Active Comparator
Arm Description
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
Arm Title
African American Registry: Culturally Targeted
Arm Type
Experimental
Arm Description
African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.
Intervention Type
Behavioral
Intervention Name(s)
Culturally Targeted SARS-CoV-2 Communication
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
General SARS-CoV-2 Communication
Intervention Description
SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
Primary Outcome Measure Information:
Title
Salivary Kit Request
Description
Does participant request to receive a salivary kit from the study team? (yes-no)
Time Frame
up to 2 weeks
Title
Salivary Kit Completion
Description
Do participants who request salivary kits use/return them? (yes-no)
Time Frame
up to 8 weeks
Title
Theory of Planned Behavior Antibody Testing Outcomes
Description
Self-report measures of antibody testing attitudes, norms, perceived control, intentions to be screened are each adapted from published research (Lucas et al., 2021). These items are constructed following recommended procedures to ensure construct validity and adequate behavioral specificity (Fishbein & Ajzen, 2011). All items use Likert-type scales that range from 1 (strongly agree) to 7 (strongly disagree).
Time Frame
collected immediately, up to 1 hour
Title
Anticipatory Racism
Description
Adapted from published research (Lucas et al., 2021), all participants respond to questions that asked whether they believe racism would impact the benefits they could experience from obtaining antibody testing. Participants will then respond to three questions that ask, "In some way, my obtaining CRC screening would be impacted by racism," "Racism would undermine the value of CRC screening for me." and "Racism would negatively impact the accuracy of my CRC screening. Responses are collected using a 7-point Likert-type scale that ranged from 1 (strongly agree) to 7 (strongly disagree).
Time Frame
collected immediately, up to 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
African American or White, 18 or older, and enrolled in the Flint Registry
Exclusion Criteria:
All who do not meet inclusion criteria.
Facility Information:
Facility Name
Flint Journal Building
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available per requirements and sharing structures established by NCI "SeroNet" initiative.
IPD Sharing Time Frame
Upon Study Completion
Learn more about this trial
Culturally-Targeted COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake
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