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Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • This study will include all patients receiving clinically indicated testing for COVID-19 at a federally qualified health center (FQHC, Open Cities Health Center, St. Paul, MN). - There will be no formal recruitment of patients in this research.

Exclusion Criteria

Study Design

Phase
Study Type
Observational
Observational Model
Ecologic or Community
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Observational Intervention Rapid SARS-CoV-2 testing strategy
  • Diagnostic Test: Pilot a rapid SARS-CoV-2 testing strategy
    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.
Behavioral Intervention Community-driven messages to promote COVID-19 testing
  • Other: Community-driven messages to promote COVID-19 testing
    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).

Recruiting Locations

More Details

NCT ID
NCT04558307
Status
Completed
Sponsor
Mayo Clinic

Detailed Description

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.