Feasibility of Rapid COVID-19 Testing in Disadvantaged Populations

Completed

• Conditions: Coronavirus Disease (COVID-19)
• Interventions: Diagnostic Test: Pilot a rapid SARS-CoV-2 testing strategy; Other: Community-driven messages to promote COVID-19 testing

• Registration Number: NCT04558307
• Lead Sponsor: Mayo Clinic

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).

Study Timeline

• Study Start: 2020-06-03
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-18
• Study First Posted: 2020-09-22
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Read More

Exclusion Criteria

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Intervention	Pilot a rapid SARS-CoV-2 testing strategy	Rapid SARS-CoV-2 testing strategy
Behavioral Intervention	Community-driven messages to promote COVID-19 testing	Community-driven messages to promote COVID-19 testing

Primary Outcome Measures

Name	Time	Method
2. Uptake of rapid SARS-CoV-2 testing strategy at the FQHC- Effectiveness of community-driven messaging to patients	6-months after intervention start	Comparison of number of tests completed per group (intervention vs. control)
Uptake of rapid SARS-CoV-2 testing strategy at the FQHC	9-months after intervention start	Comparison of number of tests completed per group (intervention vs. control)
Intervention Feasibility Measures - FQHC Staff	6-months after intervention start	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.).

Secondary Outcome Measures

Name	Time	Method
Intervention Satisfaction Measures - Participant Satisfaction with COVID-19 testing	6-months after intervention start	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.).
5. Intervention Satisfaction Measures - Participant Satisfaction with community-driven messaging	6-months after intervention start	Compare the satisfaction of community-driven messaging on availability of rapid SARS-CoV-2 testing at the FQHC (intervention vs. control)

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States