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

NCT04957082 | Completed Results

• 2 other identifiers: MSUSeronet1U01CA260469
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2 Infection

Keywords

SARS-CoV-2; COVID-19; Health Disparities; Health Communication; Antibodies

Outcome Measures

Primary Outcomes (7)

• 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.

Study Arms (3)

White Flint Registry: General

ACTIVE COMPARATOR

White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.

Behavioral: General SARS-CoV-2 Communication

African American Registry: General

ACTIVE COMPARATOR

African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.

Behavioral: General SARS-CoV-2 Communication

African American Registry: Culturally Targeted

EXPERIMENTAL

African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.

Behavioral: Culturally Targeted SARS-CoV-2 Communication

Interventions

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.

African American Registry: Culturally Targeted

General SARS-CoV-2 Communication BEHAVIORAL

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

African American Registry: General; White Flint Registry: General

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Michigan State University: lead
• National Cancer Institute (NCI): collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Flint Journal Building

Flint, Michigan, 48502, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Todd Lucas
• Organization: Michigan State University

lucastod@msu.edu

810-600-5629

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of their assignment to a general versus culturally targeted condition.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 12, 2021
• Study Start: August 4, 2021
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: June 28, 2024
• Results First Posted: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Upon Study Completion

Locations

US (1)