NCT04558307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

September 18, 2020

Last Update Submit

July 12, 2021

Conditions

Coronavirus Disease (COVID-19)

Keywords

COVID-19testingcommunity engagementCommunity-based participatory researchracial and ethnic minoritiescommunity health

Outcome Measures

Primary Outcomes (3)

  • 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.).

    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)

    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)

    9-months after intervention start

Secondary Outcomes (2)

  • Intervention Satisfaction Measures - Participant Satisfaction with COVID-19 testing

    6-months after intervention start

  • 5. Intervention Satisfaction Measures - Participant Satisfaction with community-driven messaging

    6-months after intervention start

Study Arms (2)

Observational Intervention

Rapid SARS-CoV-2 testing strategy

Diagnostic Test: Pilot a rapid SARS-CoV-2 testing strategy

Behavioral Intervention

Community-driven messages to promote COVID-19 testing

Other: Community-driven messages to promote COVID-19 testing

Interventions

Pilot a rapid SARS-CoV-2 testing strategyDIAGNOSTIC_TEST

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.

Observational Intervention
Community-driven messages to promote COVID-19 testingOTHER

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).

Behavioral Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients receiving care at Open Cities Health Center.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • LaPrincess C Brewer, MD, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 22, 2020

Study Start

June 3, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

July 13, 2021

Record last verified: 2021-07

Locations

US(1)