Rural Tailored COVID-19 Communication to Promote SARS-CoV-2 Antibody Testing in Saliva

March 13, 2024 updated by: Todd Lucas, Michigan State University

Rural Tailored COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake

This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among individuals residing in rural Northern Michigan. This iteration will consider individuals recruited from rural Northern Michigan and assess individuals' willingness to participate in home-based saliva sample collections.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Rural Americans are at higher risk of many severe COVID-19 related health outcomes. These disparities are likely to endure given lower vaccination uptake in many rural communities, and also the continued emergence of SARS-COV-2 variants, even as overall vaccination rates and COVID-19 treatments improve. Better understanding and addressing rural disparities in COVID-19 could be aided by SARS-CoV-2 antibody testing that can measure herd immunity, assess vaccination efficacy and uptake, and perhaps inform re-vaccination strategies. However, implementing antibody testing education and outreach in rural contexts poses unique challenges, including that many rural communities remain skeptical of COVID-19 testing and treatment. Moreover, rural communities are racially and regionally diverse, including predominantly White populations in some rural regions, but largely African American in others. Such diversity highlights that tailoring the use of specific antibody communication strategies to particular rural contexts is critical. Another challenge posed by rural contexts is in implementing biological sample collections, including effectively distributing and receiving biospecimen collection kits and ensuring proper sample collections. Taken together, there is an urgent need to develop and evaluate communication and collection strategies that can better promote SARS-CoV-2 antibody testing in diverse rural contexts. This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among individuals residing in rural Northern Michigan. The central hypothesis is that rural Americans will be receptive to antibody testing when communication is specifically tailored, and when non-invasive home-based salivary collection is used. Our rationale is that combining effective rural health communication with home-based salivary testing will reduce skepticism and mistrust, and promote uptake that can lead to better grasping and addressing rural disparities in COVID-19. The clinical trial aims for this study are to 1) develop and compare the effects of tailored rural videos about antibody testing to general antibody education videos on salivary antibody testing attitudes, intentions, and behavior among rural White Americans residing in Michigan, and rural African Americans residing in Arkansas; 2) compare effects of tailored rural videos on activation of medical mistrust among rural White Americans in Michigan and rural African Americans in Arkansas when considering antibody testing; and 3) develop, evaluate, and compare the efficacy and fidelity of a protocol for home-based salivary collection in rural contexts that includes sending, collecting, receiving and successfully assaying for SARS-CoV-2 antibodies using salivary collection kits. In this study iteration, the investigators will consider individuals recruited from rural Northern Michigan and assess individuals' willingness to participate in home-based saliva sample collections.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • White, 18 or older

Exclusion Criteria:

  • All who do not meet inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: White Rural: General
White rural 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 rural-targeted information
Experimental: White Rural: Rural-Targeted
White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing.
Behavioral: Rural-Targeted SARS-CoV-2 Communication
SARS-CoV-2 video tutorial includes a two and a half minute video based messaging adjunct meant to enact a rural-targeted framing of health information presented to White rural individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Home-Based Salivary Kit Request
Time Frame: up to 2 weeks
Does participant request to receive a home-based salivary test kit from the study team? (yes-no)
up to 2 weeks
Home-Based Salivary Test Kit Completion
Time Frame: up to 8 weeks
Do participants who request home-based salivary test kits use/return them? (yes-no)
up to 8 weeks
Theory of Planned Behavior Antibody Testing Outcomes
Time Frame: collected immediately, up to 1 hour
Self-report measures of antibody testing attitudes, norms, perceived control, and 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
Group-Based Medical Mistrust Outcomes
Time Frame: collected immediately, up to 1 hour
Self-report measures of general feelings about the health care system are adapted from published research (Thompson et al., 2004). All items on the Group-Based Medical Mistrust measure use Likert-type scales that range from 1 (Strongly Disagree) to 5 (Strongly Agree).
collected immediately, up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Collaborators

Johns Hopkins University
National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00005016

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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