An observational study in Coronavirus Disease (COVID-19), sponsored by Mayo Clinic. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-07-13.
Sponsored by Mayo Clinic · Observational
The purpose of this study is to assess the feasibility of establishing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing at a federally-qualified health center (FQHC) during a global health crisis to mitigate COVID-19 disparities in socioeconomically disadvantaged populations.
Accurate and early diagnosis of COVID-19 infections are critical for rapid initiation of quarantine interventions to reduce population spread and to provide appropriate medical care to reduce related morbidity and mortality during the current pandemic. The purpose of this study is to assess the feasibility of establishing a drive-through rapid COVID-19 testing site at a federally-qualified health center (FQHC) during a global health crisis to mitigate health consequences in socioeconomically disadvantaged populations. The investigators also seek to evaluate the effectiveness of community-driven communication in increasing access to rapid testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in this population. This will inform public health decisions about improving access to testing for SARS-CoV-2 in underserved populations, particularly those receiving care in FQHCs or community health centers.
The specific aims of the study are to:
Aim 1. To determine the feasibility of a community-engaged research partnership to support rapid SARS-CoV-2 testing for symptomatic patients of all ages in the underserved population during the COVID-19 crisis. A rapid testing strategy (drive-through testing site) at a FQHC using Mayo Clinic Laboratory (MCL) diagnostic processing will be piloted.
Aim 2. To compare the effectiveness of community-driven messaging in increasing uptake of rapid SARS-CoV-2 testing compared with usual sources of health information. A simple random sample will be drawn of FQHC patients (N=1000, age 18+) with 1:1 randomization of communication about COVID-19 and availability of rapid testing from the FQHC versus usual sources (control).
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 1,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients receiving care at Open Cities Health Center.
Exclusion Criteria:
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Rapid SARS-CoV-2 testing strategy
Diagnostic Test: Pilot a rapid SARS-CoV-2 testing strategy
Community-driven messages to promote COVID-19 testing
Other: Community-driven messages to promote COVID-19 testing
Rapid testing strategy at an FQHC using Mayo Clinic Laboratory (MCL) diagnostic processing with a real-time polymerase chain reaction assay for SARS-CoV-2 and a Mayo Clinic drive-through collection protocol.
A one-time communication about the availability of COVID-19 testing at the FQHC to patients randomized to the intervention group using any available means of communication (text and/or mailed letter).
Intervention Feasibility Measures - FQHC Staff
FQHC staff will complete a comprehensive electronic survey adapted from the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) instrument to assess feasibility of community-engaged research partnership to support testing site (Weiner BJ, et al. Implementation Science. 2017;12(1):108.).
Time frame: 6-months after intervention start
2. Uptake of rapid SARS-CoV-2 testing strategy at the FQHC- Effectiveness of community-driven messaging to patients
Comparison of number of tests completed per group (intervention vs. control)
Time frame: 6-months after intervention start
Uptake of rapid SARS-CoV-2 testing strategy at the FQHC
Comparison of number of tests completed per group (intervention vs. control)
Time frame: 9-months after intervention start
Intervention Satisfaction Measures - Participant Satisfaction with COVID-19 testing
All randomized patients will complete a comprehensive survey with questions probing satisfaction with the drive-through testing site (ease of use, process, return of results, etc.).
Time frame: 6-months after intervention start
5. Intervention Satisfaction Measures - Participant Satisfaction with community-driven messaging
Compare the satisfaction of community-driven messaging on availability of rapid SARS-CoV-2 testing at the FQHC (intervention vs. control)
Time frame: 6-months after intervention start
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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