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Educational ActivitiesNCT05435482

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

A study testing Education, COVID-19 testing kits and Instruction in people with Educational Activities, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Educational Activities
What is being tested?
Education, COVID-19 testing kits and Instruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
259 participants
Where
1 siteUnited States
Study dates
3 Oct 2022to 30 Jun 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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.

Who cannot join

  • Participating as community advisory group member for the study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Facilitating COVID-19 At-Home Collection Testing Among Korean American Families Through Korean Schools in Northern California

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).

Being tested
Education, COVID-19 testing kits, Instruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EducationBehavioural

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

  • COVID-19 testing kitsOther

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

  • InstructionOther

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

Study groups in NCT05435482
Study groupRoleWhat they receive
LHE-ledExperimentalParticipants 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
Receives: Behavioral: Education; Other: COVID-19 testing kits; Other: Instruction
Instruction onlyActive comparatorParticipants will receive 1) COVID-19 at-home antigen test kits and 2) a written and a video guide to using a test kit
Receives: Other: COVID-19 testing kits; Other: Instruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: Week 8

Secondary outcomes (2)
  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

    Measured: 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

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2022
  2. Study start3 Oct 2022
  3. Primary completion30 Apr 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05435482
Sponsor's protocol ID
R0102
Other IDs
U24MD016258
Status last verified
Nov 2024
First submitted
24 Jun 2022
Last updated
11 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be shared upon request and data use agreement must be signed

Questions about this trial

What is this clinical trial studying?

A study testing Education, COVID-19 testing kits and Instruction in people with Educational Activities, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Who Has Been Tested for COVID-19 During the Study Period (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.

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