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

Study Overview
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Brief Summary
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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 their willingness to participate in home-based saliva sample collections.

Detailed Description
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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 to them, 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. Our clinical trial aims 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, we will consider individuals recruited from rural Northern Michigan and assess their willingness to participate in home-based saliva sample collections.

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

Conditions
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SARS-CoV2 Infection

Intervention / Treatment
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* Behavioral: General SARS-CoV-2 Communication
* Behavioral: Rural-Targeted SARS-CoV-2 Communication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: White, 18 or older Exclusion Criteria: All who do not meet inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This study will use a two-group design (Video tutorial: general versus rural-targeted). Half of White rural participants will receive general video education/messaging and half of White rural participants will be assigned to an intervention condition that includes rural-targeted information about SARS-CoV-2 antibody testing.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: White Rural: General<br>White rural participants receive general consumption video information about SARS-CoV-2 antibody testing. | Behavioral: General SARS-CoV-2 Communication<br>* SARS-CoV-2 video tutorial is for general consumption and does not include rural-targeted information<br>|
| Experimental: White Rural: Rural-Targeted<br>White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing. | Behavioral: Rural-Targeted SARS-CoV-2 Communication<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home-Based Salivary Kit Request | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19, Rural Health Disparities, Health Communication, Rural Health, Antibodies