NCT05197452

Brief Summary

This study uses a population-based approach to increase uptake of COVID-19 testing within a highly segregated and underserved African American community in Chicago.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

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

March 23, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 24, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

1.7 years

First QC Date

January 13, 2022

Results QC Date

January 11, 2024

Last Update Submit

May 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • COVID-19 Testing Uptake

    Covid testing uptake was measured as the number of neighborhood residents (i.e., count of unique participants) tested for COVID-19 at any timepoint during the study which occurred between December 2020 and August 2022. The were 397 testing events at churches or community site where participants could be tested during this time period. Individuals may have been tested more than once but were only counted once. Testing uptake was assessed as the number of participants tested at least once (n=2167). Pre and post evaluations were not performed. The measure was based a single count of participants tested.

    Up to 20 months

Other Outcomes (2)

  • Re-AIM Framework

    Up to 6 months after end of study

  • Needs Assessment

    First 2 months of the study prior to the start of the testing intervention

Study Arms (1)

COVID-19 Testing

EXPERIMENTAL

COVID-19 antigen and PCR Testing

Behavioral: COVID-19 Testing

Interventions

For in-person PCR testing, a nasal swab will be inserted shallowly into the participant's nose and rotated in each nostril. The swab will be broken off into a designated test tube and placed into a specimen bag along with a label. All specimens will be stored in a cooler until they are transported the Rush Laboratory for COVID-19 analysis. For at home antigen testing, participants will download an app to their mobile phone and watch an informational video. The test will be self-administered by inserting a nasal swab into the nostril until a cap containing the swab touches the nose; rubbing the swab tip around the nose cavity 3 times; removing the swab and repeating in the other nostril. The nasal swab, a dropper, processing fluid, and a blue tooth connected analyzer are provided with the testing kit to analyze the sample for COVID-19. COVID-19 home test results are displayed on the participants smart phone after 15 minutes.

COVID-19 Testing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All individuals who request a COVID-19 test, including pregnant women and children of all ages

You may not qualify if:

  • Individuals who have tested positive for Covid-19 in the prior 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60422, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Testing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Results Point of Contact

Title
Dr. Yolanda Cartwright
Organization
Research Manager

Study Officials

  • Elizabeth Lynch, PhD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: We established a network of testing sites in African American churches and community sites located in testing deserts in Chicago. Individuals of all ages were eligible for testing. Individuals with a confirmed COVID-19 infection within the past 3 months were ineligible. Testing was open to the public and no appointments were necessary. Testing was offered 5 days per week (at 1 or 2 locations each day) with varying hours of operation to accommodate community member's work and school schedules. There was no limit to the number of times an individual could be tested. Testing was administered by experienced mobile clinical teams of community health workers and registered nurses from Rush University Medical Center. Participants received COVID-19 education, social determinants of health screening, and free SARS-CoV-2 polymerase chain reaction (PCR) testing.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 19, 2022

Study Start

March 23, 2021

Primary Completion

November 18, 2022

Study Completion

November 18, 2022

Last Updated

May 24, 2024

Results First Posted

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations