Facilitating COVID-19 At-Home Collection Testing Among Korean American Families Through Korean Schools in Northern California
Phase: NA
Conditions: Educational Activities
Sponsor: University of California, San Francisco

 
 
 
 
 
 
 
Facilitating COVID-19 Test for Korean Americans Through Korean Schools in Northern 
California 
(NCT05435482) 
 
 
 
 
 
 
 
 
 
 
 
November 16, 2022 
 
 
 
 

Study Protocol 
Lay Health Educators (LHEs) 
LHEs will be invited to attend 2 training sessions (6 hours, orientation and intervention 
delivery) over Zoom. During the training sessions, our research team will provide LHEs 
Orientation Training Manual, which contains background information, project objectives, 
project description, LHE's responsibilities/activities, compensation/assistance, RCT 
participant's responsibilities/rights/activities, frequently asked questions, and handling 
challenging situations. LHEs will also receive the instruction to contact the research team 
if they do not know how to address the situation. The research team will ask LHEs to 
respect the privacy of others by keeping confidential any information they learn about 
others during meetings and calls. 
Coordinators 
Coordinators will not receive any training. 
RCT participants 
All individuals recruited by the schools and teachers will receive an email from the 
research team that includes the consent information for the study and a link to the online 
baseline survey. They may choose to participate by themselves (individually) or participate 
with a family member who meets the eligibility criteria to participate together. We 
anticipate each school to recruit at least five individuals. Those who agree to participate in 
the study and complete the survey will be assigned to either the LHE condition or the 
control condition, depending on the group assignment of schools they are recruited from. 
Within the two weeks, after each participant completes the baseline survey, an OTC 
COVID-19 antigen test kit, which FDA authorizes under a EUA, will be provided to each 
participant. LHE participants will receive 1) LHE outreach/support (2 small group 
educational sessions via Zoom and 2 individual follow-up calls), 2) short video clips via 
email on the project overview and the guide to using a test kit (created by the research 
team in Korean and English), 3) test kits with written instructions on COVID-19 testing by 
Centers for Disease Control and Prevention (CDC) in English and Korean, and 4) weekly 
email reminders to report the use of COVID-19 at home antigen test kits. LHE outreach 
small group educational session is about 1 hour with 2 to 6 people. LHE will present 
COVID-19 testing and related information (including vaccination and safety practices). 
Participants who participate as dyads (self-selected participation mode) are expected to 
attend the educational sessions together. At this educational session, LHE will provide 
education using PowerPoint presentations with easy-to-understand messages using 
culturally appropriate images and simple texts to present current information on 1) COVID-

19 testing; 2) relevance or reasons for getting tested; 3) the current guidelines for testing/ 
who should be tested; 4) types of tests available (e.g. PCR, antigens, and antibodies tests 
in the forms of nose swap and saliva tests); 5) understanding test results (positive versus 
negative) and the limitation of such tests (false negative); 6) the importance of repeated 
testing, discuss and address barriers for testing. LHE sessions provide a socially and 
culturally acceptable platform to engage participants to share personal stories, ask 
questions, and address concerns. At the end of each session, participants are encouraged 
to choose an “action item” from their ‘Healthy Action Plan’ to advance their knowledge 
and/or take steps toward making informed decisions about testing, and, if appropriate, 
taking steps toward getting tested. Participants have found that the LHE outreach session, 
follow-up call, and a ‘Healthy Action Plan’ have facilitated behavioral change by keeping 
them accountable. LHE may provide as-needed assistance to help a participant use a 
COVID-19 at-home antigen test kit, including demonstrating the use of the test kit.  
Statistical Analysis Plan 
We will first conduct cross-sectional analyses of baseline data and compare baseline 
participant characteristics by groups/conditions. Differences in participant characteristics 
between groups will be included as covariates in subsequent analyses. We will use 
generalized linear mixed models using COVID-19 testing receipt based on self-report by 
participants as the outcome, with random effects for school, LHE, participant and family as 
needed to account for correlation within and between participants. We will then explore 
association between structural, sociocultural, and behavioral factors at individual, 
interpersonal, and community levels in association with COVID-19 testing receipt over 
time.