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

SARS-CoV2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04957082
• Other study ID #: MSUSeronet1
• Secondary ID: U01CA260469
• Status: Completed
• Phase: N/A
• Start date: August 4, 2021
• Est. completion date: December 19, 2022

Study information

• Verified date: October 2023
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: December 19, 2022
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• All who do not meet inclusion criteria.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2 Infection

Intervention

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.
• General SARS-CoV-2 Communication
SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information

Locations

Country	Name	City	State
United States	Flint Journal Building	Flint	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Michigan State University	Johns Hopkins University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary Kit Request	Does participant request to receive a salivary kit from the study team? (yes-no)	up to 2 weeks
Primary	Salivary Kit Completion	Do participants who request salivary kits use/return them? (yes-no)	up to 8 weeks
Primary	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).	collected immediately, up to 1 hour
Primary	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).	collected immediately, up to 1 hour