Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06085547 |
| Other study ID # |
00005016 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
December 30, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Michigan State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
