CClinicalTrials.gg
CompletedNCT05435482Updated Dec 11, 2024Results posted

Facilitating COVID-19 Test for Korean Americans Through Korean Schools in Northern California

An interventional study of Education and COVID-19 testing kits in Educational Activities, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-11.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
259
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

In collaboration with Korean Schools of Northern California, the investigators will test if a community-based intervention delivered by lay health educators (LHEs) increases testing uptake among Korean Americans. A pilot cluster randomized controlled trial (RCT) with 300 participants from about 12 Korean Schools will be conducted to evaluate the efficacy of the LHE-led intervention in promoting COVID-19 testing. Participating schools will recruit Korean Schoolteachers as LHEs. According to the group assignment of schools where participants are recruited, the LHE group participants will receive 1) LHE outreach/support, 2) COVID-19 at-home antigen test kits, and 3) the instruction to use the kit while the control group participants will receive test kits and the instruction. Participants will complete an online survey at baseline, weeks 4, and 8. The primary outcome is the COVID-19 testing receipt. The secondary outcomes are intention to get tested, perceived accuracy, benefits and risks of testing, perceived barriers to testing, understanding of negative or positive results, and family members' testing receipt.

Read the detailed description

Lay Health Educators (LHEs) Korean Schools in Northern California will be classified into two strata by geographic location (urban, suburban/rural). Collaborating with the KSNC, our research team will recruit about 12 schools (6 urban and 6 suburban/rural). Within each stratum, schools will be randomly assigned in a 1-to-1 ratio to either the LHE-plus-instruction condition (LHE condition) or the instruction-only condition (control condition). Participating schools will recruit two teachers as LHEs (LHE condition only), ii) announce the proposed study to enrolled students' parents, iii) recruit KAs from the school and/or community, and iv) distribute at-home antigen test kits to participants. Research staff will contact potential LHEs to conduct a brief telephone screening to find out their eligibility. If they meet the eligibility and provide an informed consent form via DocuSign, they will be invited to attend two 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, lay health educator'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 problems. 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.

RCT participants All individuals recruited by the schools will receive an email from the research team that includes the consent information of 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. Each school will recruit about 25 individuals. Those who complete the baseline survey will be assigned to LHE condition or control condition, depending on the group assignment of schools where they are recruited. Within the two weeks after each participant completes the baseline survey, a 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), and 3) test kits with written instructions on COVID-19 testing by Centers for Disease Control and Prevention (CDC) in English and Korean. 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 in a dyad (self-selected participation mode) will attend the educational sessions together. At these educational sessions, 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 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, discussing and addressing barriers for testing. LHE may assist in helping the participant use a COVID-19 at-home antigen test kit, including demonstrating the use of the test kit. Participants will be assessed via online survey or by telephone of their choice at baseline, weeks 4 and 8. Participants will receive up to $70 gift cards for completing all the surveys: $20 for baseline, $20 for week 4, and $30 for week 8. Control participants will receive the same components of the LHE condition except for LHE outreach/support. All control participants will be assessed at the same schedule: baseline, weeks 4 and 8. They will receive the same incentives ($70 gift cards for completing all assessments).

02

Conditions studied

  • Educational Activities
03

In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

For Lay Health Educators (LHE), inclusion criteria are:

  • age 18 and older;
  • self-identify as Korean or Korean American;
  • fluent in spoken and written Korean; and
  • live in communities where participating schools are located.

For RCT participants, inclusion criteria are:

  • age 18 and older;
  • self-identify as Korean or Korean American;
  • read and speak English or Korean;
  • live in communities where participating schools are located; and
  • have access to a phone to receive follow-up calls from LHEs.

Exclusion criteria

Exclusion Criteria:

  • Participating as community advisory group member for the study
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
259 participants (actual)

Study arms

  • Experimental
    LHE-led

    Participants will receive 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

    Behavioral: Education · Other: COVID-19 testing kits · Other: Instruction

  • Active comparator
    Instruction only

    Participants will receive 1) COVID-19 at-home antigen test kits and 2) a written and a video guide to using a test kit

    Other: COVID-19 testing kits · Other: Instruction

Interventions

  • BehavioralEducation

    Participants will receive two small group meetings and two follow-up calls

  • OtherCOVID-19 testing kits

    Participants will receive two COVID-19 at-home antigen test kits.

  • OtherInstruction

    Participants will receive a written guide and a video clip guide to the test kit.

06

What researchers measure

Primary outcomes

  1. Proportion of Participants Who Has Been Tested for COVID-19 During the Study Period

    Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program

    Time frame: Week 4

  2. Proportion of Participants Who Has Been Tested for COVID-19 During the Study

    Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program

    Time frame: Week 8

Secondary outcomes

  1. Intention to Get Tested for COVID-19

    Participants 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

    Time frame: Week 4

  2. Intention to Get Tested for COVID-19

    Participants 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

    Time frame: Week 8

07

Results

Posted Nov 15, 2024

Participant flow

A total of 259 people were recruited. However, 18 clusters were randomized and a total of 220 completed the baseline survey.

Participant flow — Overall Study
MilestoneLHE-ledInstruction Only
Started109111
Completed102106
Not completed75

Outcome measures

PrimaryProportion of Participants Who Has Been Tested for COVID-19 During the Study Period

Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program

Time frame:
Week 4
Reported as:
Count of participants · Participants
Proportion of Participants Who Has Been Tested for COVID-19 During the Study Period
ParticipantsInstruction OnlyLHE-led
Proportion of Participants Who Has Been Tested for COVID-19 During the Study Period3451
PrimaryProportion of Participants Who Has Been Tested for COVID-19 During the Study

Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program

Time frame:
Week 8
Reported as:
Count of participants · Participants
Proportion of Participants Who Has Been Tested for COVID-19 During the Study
ParticipantsInstruction OnlyLHE-led
Proportion of Participants Who Has Been Tested for COVID-19 During the Study3028
SecondaryIntention to Get Tested for COVID-19

Participants 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

Time frame:
Week 4
Reported as:
Count of participants · Participants
Intention to Get Tested for COVID-19
ParticipantsInstruction OnlyLHE-led
Intention to Get Tested for COVID-196283
SecondaryIntention to Get Tested for COVID-19

Participants 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

Time frame:
Week 8
Reported as:
Count of participants · Participants
Intention to Get Tested for COVID-19
ParticipantsInstruction OnlyLHE-led
Intention to Get Tested for COVID-197082

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Instruction Only0/106 (0%)0/106 (0%)0/106 (0%)
LHE-led0/102 (0%)0/102 (0%)0/102 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Instruction OnlyLHE-ledTotal
Mean44.2 ± 11.442.8 ± 11.643.5 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Instruction OnlyLHE-ledTotal
Female7585160
Male362460
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Instruction OnlyLHE-ledTotal
Korean111109220
Region of Enrollment
Region of Enrollment(participants)Instruction OnlyLHE-ledTotal
United States111109220
Intention to get tested for COVID-19 as needed
Intention to get tested for COVID-19 as needed(Participants)Instruction OnlyLHE-ledTotal
Count of participants6566131
COVID-19 Testing receipts in the past 30 days
COVID-19 Testing receipts in the past 30 days(Participants)Instruction OnlyLHE-ledTotal
Count of participants222951
08

Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94143, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 16, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified data will be shared upon request and data use agreement must be signed

Supporting information: Icf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05435482
Lead sponsor
University of California, San Francisco
Collaborators
Duke Clinical Research Institute, National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Sponsor
First posted
Jun 28, 2022
Start date
Oct 3, 2022
Primary completion
Apr 30, 2023
Completion
Jun 30, 2023
Results posted
Nov 15, 2024
Last update
Dec 11, 2024

Study contacts

JiWon Choi, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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