Trial Outcomes & Findings for Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing (NCT NCT04949243)
NCT ID: NCT04949243
Last Updated: 2023-09-22
Results Overview
Number of participants who reported at their first follow-up assessment as having close contact (within 6 feet) with people who do not live with them.
COMPLETED
338 participants
2 weeks
2023-09-22
Participant Flow
The project team utilized a robust communications campaign and mobilized community partners to assist with outreach and to organize COVID-19 (SARs-CoV-2) antigen testing kit distribution events. Community members received tests via online order (distributed by Amazon), and in person at local distribution centers and events.
Participant milestones
| Measure |
People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits
The observational sub-study was open to the general population of targeted counties, and embedded within the larger public health intervention that distributed at-home, self-administered COVID tests. The sub-study looked at potential socio-behavioral mechanisms of SARS-CoV-2 Community Transmission: social interactions, health behaviors, healthcare utilization, knowledge, disease burden, feasibility of at-home testing.
|
|---|---|
|
Overall Study
STARTED
|
338
|
|
Overall Study
COMPLETED
|
263
|
|
Overall Study
NOT COMPLETED
|
75
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing
Baseline characteristics by cohort
| Measure |
People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits
n=338 Participants
The observational sub-study was open to the general population of targeted counties, and embedded within the larger public health intervention that distributed at-home, self-administered COVID tests. The sub-study looked at potential socio-behavioral mechanisms of SARS-CoV-2 Community Transmission: social interactions, health behaviors, healthcare utilization, knowledge, disease burden, feasibility of at-home testing.
|
|---|---|
|
Age, Continuous
|
47.10 years
STANDARD_DEVIATION 14.37 • n=99 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
226 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
88 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Sex · Not Indicated
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
295 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
252 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
338 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Data not collected on 116 participants.
Number of participants who reported at their first follow-up assessment as having close contact (within 6 feet) with people who do not live with them.
Outcome measures
| Measure |
People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits
n=222 Participants
The observational sub-study was open to the general population of targeted counties, and embedded within the larger public health intervention that distributed at-home, self-administered COVID tests. The sub-study looked at potential socio-behavioral mechanisms of SARS-CoV-2 Community Transmission: social interactions, health behaviors, healthcare utilization, knowledge, disease burden, feasibility of at-home testing.
|
|---|---|
|
Number of Participants Who Reported Not Following Social Distancing Guidelines
|
164 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Data not collected on 114 participants.
Number of participants who reported at their first follow-up assessment as having avoided public spaces, gatherings, or crowds as a prevention measure.
Outcome measures
| Measure |
People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits
n=224 Participants
The observational sub-study was open to the general population of targeted counties, and embedded within the larger public health intervention that distributed at-home, self-administered COVID tests. The sub-study looked at potential socio-behavioral mechanisms of SARS-CoV-2 Community Transmission: social interactions, health behaviors, healthcare utilization, knowledge, disease burden, feasibility of at-home testing.
|
|---|---|
|
Number of Participants That Avoided Public Spaces, Gatherings, or Crowds as a Prevention Measure
|
84 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsOutcome measures
| Measure |
People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits
n=338 Participants
The observational sub-study was open to the general population of targeted counties, and embedded within the larger public health intervention that distributed at-home, self-administered COVID tests. The sub-study looked at potential socio-behavioral mechanisms of SARS-CoV-2 Community Transmission: social interactions, health behaviors, healthcare utilization, knowledge, disease burden, feasibility of at-home testing.
|
|---|---|
|
Number of Participants With Positive SARs-CoV-2 Antigen Test Results
|
7 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data not collected.
Outcome measures
Outcome data not reported
Adverse Events
People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place