Culturally-Targeted COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake

Culturally-targeted Communication to Promote SARS-CoV-2 Antibody Testing in Saliva: Enabling Evaluation of Inflammatory Pathways in COVID-19 Racial Disparities

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV2 Infection
• Intervention / Treatment: Behavioral: General SARS-CoV-2 Communication; Behavioral: Culturally Targeted SARS-CoV-2 Communication

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.

• Study Type: Interventional
• Enrollment (Actual): 666
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48502
      • Flint Journal Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• African American or White, 18 or older, and enrolled in the Flint Registry

Exclusion Criteria:

• All who do not meet inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: White Flint Registry: General; White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.	Behavioral: General SARS-CoV-2 Communication; SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
Active Comparator: African American Registry: General; African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.	Behavioral: General SARS-CoV-2 Communication; SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
Experimental: African American Registry: Culturally Targeted; African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: Johns Hopkins University; National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2021
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Health Disparities; Antibodies; Health Communication
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MSUSeronet1; U01CA260469 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available per requirements and sharing structures established by NCI "SeroNet" initiative.
• IPD Sharing Time Frame: Upon Study Completion
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No