Trial Outcomes & Findings for RADx-UP CDCC Rapid Research Pilot Program "Culturally-relevant Community Connections (C3) to Increase COVID-19 Testing (NCT NCT05918952)
NCT ID: NCT05918952
Last Updated: 2026-01-02
Results Overview
Recruitment status
COMPLETED
Target enrollment
327 participants
Primary outcome timeframe
24-48 hours
Results posted on
2026-01-02
Participant Flow
Two beauty salons and three barbershops agreed to partner to implement this project. Recruitment of customers in these shops took place through word of mouth, an IRB-approved recruitment flyer, and through the co-developed edutainment videos.
Participant milestones
| Measure |
Culturally-relevant Community Connections (C3)
1-health COVID-19 test and Video
Covid-19 Antibody Test: The investigators propose to use the iHealth® Rapid COVID-19 Antigen Rapid Test. Per the EUA guidance, study participants will complete one test at a study location and receive one test to take home with instructions to complete it within 48 hours.
Each testing site will have a private designated space for customers to self-collect and test themselves privately. The edutainment video will serve as a resource for information on accurate test performance. Test one will be done in a private setting and results entered into REDcap and will also be written on a testing card with contact information for the purpose of follow-up. For test number two the customer will self-collect within 48 hours (per the FDA EUA for this particular test) and results will be entered into RedCap.
Short Clip videos: Designed to discuss the testing process, the importance of getting tested and accessing care, and how COVID-19 has disproportionately affected the Black/African-American community.
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|---|---|
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Overall Study
STARTED
|
327
|
|
Overall Study
COMPLETED
|
327
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RADx-UP CDCC Rapid Research Pilot Program "Culturally-relevant Community Connections (C3) to Increase COVID-19 Testing
Baseline characteristics by cohort
| Measure |
Culturally-relevant Community Connections (C3)
n=327 Participants
1-health COVID-19 test and Video
Covid-19 Antibody Test: The investigators propose to use the iHealth® Rapid COVID-19 Antigen Rapid Test. Per the EUA guidance, study participants will complete one test at a study location and receive one test to take home with instructions to complete it within 48 hours.
Each testing site will have a private designated space for customers to self-collect and test themselves privately. The edutainment video will serve as a resource for information on accurate test performance. Test one will be done in a private setting and results entered into REDcap and will also be written on a testing card with contact information for the purpose of follow-up. For test number two the customer will self-collect within 48 hours (per the FDA EUA for this particular test) and results will be entered into RedCap.
Short Clip videos: Designed to discuss the testing process, the importance of getting tested and accessing care, and how COVID-19 has disproportionately affected the Black/African-American community.
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|---|---|
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Age, Continuous
|
42.26 Years
STANDARD_DEVIATION 13.32 • n=228 Participants
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|
Sex/Gender, Customized
Sex/Gender · Female
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186 Participants
n=228 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
128 Participants
n=228 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Other
|
13 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
310 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=228 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Black or African American
|
315 Participants
n=228 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=228 Participants
|
PRIMARY outcome
Timeframe: 24-48 hoursOutcome measures
| Measure |
Culturally-relevant Community Connections (C3)
n=327 Participants
1-health COVID-19 test and Video
Covid-19 Antibody Test: The investigators propose to use the iHealth® Rapid COVID-19 Antigen Rapid Test. Per the EUA guidance, study participants will complete one test at a study location and receive one test to take home with instructions to complete it within 48 hours.
Each testing site will have a private designated space for customers to self-collect and test themselves privately. The edutainment video will serve as a resource for information on accurate test performance. Test one will be done in a private setting and results entered into REDcap and will also be written on a testing card with contact information for the purpose of follow-up. For test number two the customer will self-collect within 48 hours (per the FDA EUA for this particular test) and results will be entered into RedCap.
Short Clip videos: Designed to discuss the testing process, the importance of getting tested and accessing care, and how COVID-19 has disproportionately affected the Black/African-American community.
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|---|---|
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Number of Participants With Completed COVID-19 Tests
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73 Participants
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PRIMARY outcome
Timeframe: BaselineThe CTDMS is an 8-item measure with 2 subscales: General Sentiment (4 items) and Practical Support (4 items). The GS subscale score is calculated as a mean with a range of 1 to 5. Higher scores indicate stronger agreement with positive general attitudes and experiences toward COVID-19.
Outcome measures
| Measure |
Culturally-relevant Community Connections (C3)
n=327 Participants
1-health COVID-19 test and Video
Covid-19 Antibody Test: The investigators propose to use the iHealth® Rapid COVID-19 Antigen Rapid Test. Per the EUA guidance, study participants will complete one test at a study location and receive one test to take home with instructions to complete it within 48 hours.
Each testing site will have a private designated space for customers to self-collect and test themselves privately. The edutainment video will serve as a resource for information on accurate test performance. Test one will be done in a private setting and results entered into REDcap and will also be written on a testing card with contact information for the purpose of follow-up. For test number two the customer will self-collect within 48 hours (per the FDA EUA for this particular test) and results will be entered into RedCap.
Short Clip videos: Designed to discuss the testing process, the importance of getting tested and accessing care, and how COVID-19 has disproportionately affected the Black/African-American community.
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|---|---|
|
COVID-19 Testing Decision-Making Scale (CTDMS) General Sentiment (GS) Subscale
|
2.41 score on a scale
Standard Deviation 0.93
|
PRIMARY outcome
Timeframe: BaselineThe CTDMS is an 8-item measure with 2 subscales: General Sentiment (4 items) and Practical Support (4 items). The PS subscale score is calculated as a mean with a range of 1 to 5. Higher scores reflect greater perceived practical support for testing (e.g., importance, accessibility).
Outcome measures
| Measure |
Culturally-relevant Community Connections (C3)
n=327 Participants
1-health COVID-19 test and Video
Covid-19 Antibody Test: The investigators propose to use the iHealth® Rapid COVID-19 Antigen Rapid Test. Per the EUA guidance, study participants will complete one test at a study location and receive one test to take home with instructions to complete it within 48 hours.
Each testing site will have a private designated space for customers to self-collect and test themselves privately. The edutainment video will serve as a resource for information on accurate test performance. Test one will be done in a private setting and results entered into REDcap and will also be written on a testing card with contact information for the purpose of follow-up. For test number two the customer will self-collect within 48 hours (per the FDA EUA for this particular test) and results will be entered into RedCap.
Short Clip videos: Designed to discuss the testing process, the importance of getting tested and accessing care, and how COVID-19 has disproportionately affected the Black/African-American community.
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|---|---|
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COVID-19 Testing Decision-Making Scale (CTDMS) Practical Support (PS) Subscale
|
3.68 score on a scale
Standard Deviation 0.80
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SECONDARY outcome
Timeframe: 24 hoursThe VFS contains 9 items, each with a response scale of 1 to 5. The VFS total score is calculated as a mean with a range of 1 to 5. Higher scores indicate greater perceived impact, cultural resonance, and acceptability of the intervention videos for health behavior change.
Outcome measures
| Measure |
Culturally-relevant Community Connections (C3)
n=327 Participants
1-health COVID-19 test and Video
Covid-19 Antibody Test: The investigators propose to use the iHealth® Rapid COVID-19 Antigen Rapid Test. Per the EUA guidance, study participants will complete one test at a study location and receive one test to take home with instructions to complete it within 48 hours.
Each testing site will have a private designated space for customers to self-collect and test themselves privately. The edutainment video will serve as a resource for information on accurate test performance. Test one will be done in a private setting and results entered into REDcap and will also be written on a testing card with contact information for the purpose of follow-up. For test number two the customer will self-collect within 48 hours (per the FDA EUA for this particular test) and results will be entered into RedCap.
Short Clip videos: Designed to discuss the testing process, the importance of getting tested and accessing care, and how COVID-19 has disproportionately affected the Black/African-American community.
|
|---|---|
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Video Feedback Scale (VFS)
|
4.27 units on a scale
Standard Deviation 0.64
|
Adverse Events
Testing Group
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. Schenita Randolph
Duke University School of Nursing
Phone: 919-684-3786
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place