Clinical trial NCT06085547: Rural Tailored COVID-19 Communication to Promote SARS-CoV-2 Antibody Testing in Saliva
Official title: Rural Tailored COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV2 Infection
Keywords: SARS-CoV-2
COVID-19
Rural Health Disparities
Health Communication
Rural Health
Antibodies
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: National Cancer Institute (NCI)
First posted: 2023-10-17
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

Brief summary: 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.

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. The 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.

Eligibility criteria: Inclusion Criteria:

* White, 18 or older

Exclusion Criteria:

* All who do not meet inclusion criteria

Primary outcomes:
measure: Number (Percentage) of Participants Requested to Participate in Home-based Saliva-based SARS-CoV-2 Antibody Testing.
timeFrame: Immediately following didactic study portion and health communication randomization on day 1.
measure: Number (Percentage) of Participants Who Completed Home-based Salivary Antibody Testing.
timeFrame: 8 weeks from the day of consenting to participate in the home-based salivary-based SARS-CoV-2 antibody testing.
measure: Theory of Planned Behavior Antibody Testing Outcomes
timeFrame: collected immediately, up to 1 hour
measure: Antibody Testing Rural-Adapted Anticipatory Racism
timeFrame: Immediately following didactic study portion and health communication randomization on day 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Flint
country: United States
facility: Flint Journal Building
state: Michigan
Study officials:
References: