Trial Outcomes & Findings for Increasing COVID-19 Testing in Chicago's African American Testing Desserts (NCT NCT05197452)

NCT ID: NCT05197452

Last Updated: 2024-05-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

2167 participants

Primary outcome timeframe

Up to 20 months

Results posted on

2024-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Arm Only We only had a single arm in this trial because there were not sufficient data points to test our original hypothesis. The intervention arm consisted of individuals who received a Covid PCR test. Enrollment is closed and all collected data is currently reported.
Overall Study STARTED	2167
Overall Study COMPLETED	2167
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Increasing COVID-19 Testing in Chicago's African American Testing Desserts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	COVID-19 Testing n=2167 Participants COVID-19 antigen and PCR Testing COVID-19 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. At home testing was performed by inserting a nasal swab into the nostril until the cap containing the swab touched 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 were 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.
Age, Categorical <=18 years	264 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1582 Participants n=5 Participants
Age, Categorical >=65 years	321 Participants n=5 Participants
Age, Continuous	43.5 years STANDARD_DEVIATION 19.9 • n=5 Participants
Sex: Female, Male Female	1184 Participants n=5 Participants
Sex: Female, Male Male	983 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1506 Participants n=5 Participants
Race (NIH/OMB) White	152 Participants n=5 Participants
Race (NIH/OMB) More than one race	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	489 Participants n=5 Participants
Region of Enrollment United States	2167 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 20 months

Population: The analysis population included unique individuals tested for Covid-19

Outcome measures

Outcome measures
Measure	COVID-19 Testing n=2167 Participants COVID-19 antigen and PCR Testing COVID-19 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.
COVID-19 Testing Uptake	2167 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months after end of study

Population: We did not have enough enrolled participants to assess this outcome.

Use the RE-AIM framework to assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance of the ACN COVID-19 testing intervention.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

Population: 215 participants who completed the needs assessment survey

Evaluate COVID-19 testing history, attitudes towards COVID-19 testing, and perceived risk of COVID-19 via survey.

Outcome measures

Outcome measures
Measure	COVID-19 Testing n=215 Participants COVID-19 antigen and PCR Testing COVID-19 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.
Needs Assessment Tested for Covid-19 at least once	112 participants
Needs Assessment Previously tested positive for Covid-19	20 participants
Needs Assessment Had a family member, friend, or colleague who tested positive for Covid 19	183 participants
Needs Assessment Had a family member, friend, or colleague who died from Covid 19	129 participants
Needs Assessment Thought a family member, friend or colleague would get Covid 19 in the future	185 participants
Needs Assessment Thought that they themselves would get Covid 19 in the future	90 participants
Needs Assessment Would get tested at a church in their neighborhood if availble	182 participants

Adverse Events

Intervention Arm Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yolanda Cartwright

Research Manager

Phone: 224-420-0323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place