Trial Outcomes & Findings for Facilitating COVID-19 Test for Korean Americans Through Korean Schools in Northern California (NCT NCT05435482)
NCT ID: NCT05435482
Last Updated: 2024-12-11
Results Overview
Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
259 participants
Primary outcome timeframe
Week 4
Results posted on
2024-12-11
Participant Flow
A total of 259 people were recruited. However, 18 clusters were randomized and a total of 220 completed the baseline survey.
Participant milestones
| Measure |
LHE-led
Participants recruited by teachers or online platforms completed the initial online survey. Those who met the eligibility and wanted to participate in the project signed the online consent form and completed the baseline online survey. Once at least 10 participants from specific regions (San Francisco/San Mateo, East Bay, Santa Clara, and Sacramento) were gathered through teachers and/or online platforms to form clusters, our research team randomly assigned these clusters to either the intervention or control group.
Participants received 1) LHE outreach/support (2 small group educational sessions via Zoom and 2 individual follow-up calls), 2) COVID-19 at-home antigen test kits, and 3) a written and a video guide to using a test kit
|
Instruction Only
Participants recruited by teachers or online platforms completed the initial online survey. Those who met the eligibility and wanted to participate in the project signed the online consent form and completed the baseline online survey. Once at least 10 participants from specific regions (San Francisco/San Mateo, East Bay, Santa Clara, and Sacramento) were gathered through teachers and/or online platforms to form clusters, our research team randomly assigned these clusters to either the intervention or control group.
Participants received 1) COVID-19 at-home antigen test kits and 2) a written and a video guide to using a test kit.
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
111
|
|
Overall Study
COMPLETED
|
102
|
106
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Facilitating COVID-19 Test for Korean Americans Through Korean Schools in Northern California
Baseline characteristics by cohort
| Measure |
Instruction Only
n=111 Participants
Participants received 1) COVID-19 at-home antigen test kits and 2) a written and a video guide to using a test kit.
|
LHE-led
n=109 Participants
Participants received 1) LHE outreach/support (2 small group educational sessions via Zoom and 2 individual follow-up calls), 2) COVID-19 at-home antigen test kits, and 3) a written and a video guide to using a test kit
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Korean
|
111 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=5 Participants
|
109 participants
n=7 Participants
|
220 participants
n=5 Participants
|
|
Intention to get tested for COVID-19 as needed
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
COVID-19 Testing receipts in the past 30 days
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program
Outcome measures
| Measure |
Instruction Only
n=109 Participants
Participants received 1) COVID-19 at-home antigen test kits and 2) a written and a video guide to using a test kit.
|
LHE-led
n=104 Participants
Participants received 1) LHE outreach/support (2 small group educational sessions via Zoom and 2 individual follow-up calls), 2) COVID-19 at-home antigen test kits, and 3) a written and a video guide to using a test kit
|
|---|---|---|
|
Proportion of Participants Who Has Been Tested for COVID-19 During the Study Period
|
34 Participants
|
51 Participants
|
PRIMARY outcome
Timeframe: Week 8Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program
Outcome measures
| Measure |
Instruction Only
n=105 Participants
Participants received 1) COVID-19 at-home antigen test kits and 2) a written and a video guide to using a test kit.
|
LHE-led
n=102 Participants
Participants received 1) LHE outreach/support (2 small group educational sessions via Zoom and 2 individual follow-up calls), 2) COVID-19 at-home antigen test kits, and 3) a written and a video guide to using a test kit
|
|---|---|---|
|
Proportion of Participants Who Has Been Tested for COVID-19 During the Study
|
30 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Week 4Participants are asked to rate their Intention to get tested for COVID-19. A score at 3 or higher is considered as having intention to get tested for COVID-19
Outcome measures
| Measure |
Instruction Only
n=109 Participants
Participants received 1) COVID-19 at-home antigen test kits and 2) a written and a video guide to using a test kit.
|
LHE-led
n=104 Participants
Participants received 1) LHE outreach/support (2 small group educational sessions via Zoom and 2 individual follow-up calls), 2) COVID-19 at-home antigen test kits, and 3) a written and a video guide to using a test kit
|
|---|---|---|
|
Intention to Get Tested for COVID-19
|
62 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: Week 8Participants are asked to rate their Intention to get tested for COVID-19. A score at 3 or higher is considered as having intention to get tested for COVID-19
Outcome measures
| Measure |
Instruction Only
n=105 Participants
Participants received 1) COVID-19 at-home antigen test kits and 2) a written and a video guide to using a test kit.
|
LHE-led
n=102 Participants
Participants received 1) LHE outreach/support (2 small group educational sessions via Zoom and 2 individual follow-up calls), 2) COVID-19 at-home antigen test kits, and 3) a written and a video guide to using a test kit
|
|---|---|---|
|
Intention to Get Tested for COVID-19
|
70 Participants
|
82 Participants
|
Adverse Events
Instruction Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LHE-led
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place