Clinical trial NCT04558307: Feasibility of Rapid COVID-19 Testing in Disadvantaged Populations
Official title: Enhancing Rapid Health Response in National Crises: Feasibility of Rapid COVID-19 Testing in Disadvantaged Populations Through Community-Academic Partnerships
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease (COVID-19)
Keywords: COVID-19
testing
community engagement
Community-based participatory research
racial and ethnic minorities
community health
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving care at Open Cities Health Center.

Brief summary: 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.

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).

Eligibility criteria: 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:

-

Primary outcomes:
measure: Intervention Feasibility Measures - FQHC Staff
timeFrame: 6-months after intervention start
measure: 2. Uptake of rapid SARS-CoV-2 testing strategy at the FQHC- Effectiveness of community-driven messaging to patients
timeFrame: 6-months after intervention start
measure: Uptake of rapid SARS-CoV-2 testing strategy at the FQHC
timeFrame: 9-months after intervention start
Secondary outcomes:
measure: Intervention Satisfaction Measures - Participant Satisfaction with COVID-19 testing
timeFrame: 6-months after intervention start
measure: 5. Intervention Satisfaction Measures - Participant Satisfaction with community-driven messaging
timeFrame: 6-months after intervention start
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: LaPrincess C Brewer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: