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

Educational Activities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05435482
• Other study ID #: R0102
• Status: Completed
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• Participating as community advisory group member for the study

Related Conditions & MeSH terms

• Educational Activities

Intervention

Behavioral:
• Education
Participants will receive two small group meetings and two follow-up calls

Other:
• COVID-19 testing kits
Participants will receive two COVID-19 at-home antigen test kits.
• Instruction
Participants will receive a written guide and a video clip guide to the test kit.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Duke Clinical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 4
Primary	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	Week 8
Secondary	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	Week 4
Secondary	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	Week 8