- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05197452
Increasing COVID-19 Testing in Chicago's African American Testing Desserts
Alive Church Network: Increasing COVID-19 Testing in Chicago's African American Testing Deserts
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60422
- Rush University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• All individuals who request a COVID-19 test, including pregnant women and children of all ages
Exclusion Criteria:
• Individuals who have tested positive for Covid-19 in the prior 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: COVID-19 Testing
COVID-19 antigen and PCR Testing
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 Testing Uptake
Time Frame: 31 weeks
|
The number of neighborhood residents tested for COVID-19
|
31 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Re-AIM Framework
Time Frame: Up to 6 months after end of study
|
Use the RE-AIM framework to assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance of the ACN COVID-19 testing intervention.
|
Up to 6 months after end of study
|
Needs Assessment
Time Frame: First 2 months of the study
|
Conduct a rapid needs assessment to identify barriers to and facilitators of COVID-19 testing to inform a tailored outreach and intervention strategy to increase Covid-19 testing among high-risk African Americans.
The John Hopkins Covid 19 Community Response survey will used to assess perceptions, knowledge, attitudes, barriers and access to Covid-19 testing.
|
First 2 months of the study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth Lynch, PhD, Rush University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20110407
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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