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

NCT ID: NCT04957082

Last Updated: 2024-06-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

666 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-04

Study Completion Date

2022-12-19

Brief Summary

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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

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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.

Conditions

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SARS-CoV2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants
Participants will be unaware of their assignment to a general versus culturally targeted condition.

Study Groups

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White Flint Registry: General

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

Group Type ACTIVE_COMPARATOR

General SARS-CoV-2 Communication

Intervention Type BEHAVIORAL

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

African American Registry: General

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

Group Type ACTIVE_COMPARATOR

General SARS-CoV-2 Communication

Intervention Type BEHAVIORAL

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

African American Registry: Culturally Targeted

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

Group Type EXPERIMENTAL

Culturally Targeted SARS-CoV-2 Communication

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

General SARS-CoV-2 Communication

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* African American or White, 18 or older, and enrolled in the Flint Registry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Todd Lucas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Flint Journal Building

Flint, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U01CA260469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSUSeronet1

Identifier Type: -

Identifier Source: org_study_id

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