We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05435482
Recruitment Status : Not yet recruiting
First Posted : June 28, 2022
Last Update Posted : June 28, 2022
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Educational Activities Behavioral: Education Other: COVID-19 testing kits Other: Instruction Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Facilitating COVID-19 At-Home Collection Testing Among Korean American Families Through Korean Schools in Northern California
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

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

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

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




Primary Outcome Measures :
  1. Proportion of participants who has been tested for COVID-19 during the study period [ Time Frame: Week 4 ]
    Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program

  2. Proportion of participants who has been tested for COVID-19 during the study [ Time Frame: Week 8 ]
    Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program


Secondary Outcome Measures :
  1. Intention to get tested for COVID-19 [ Time Frame: Week 4 ]
    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

  2. Intention to get tested for COVID-19 [ Time Frame: Week 8 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05435482


Contacts
Layout table for location contacts
Contact: JiWon Choi, PhD 415-514-2534 jiwon.choi@ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: JiWon Choi, PhD    415-514-2534    jiwon.choi@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Duke Clinical Research Institute
Investigators
Layout table for investigator information
Principal Investigator: JiWon Choi, PhD University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05435482    
Other Study ID Numbers: R0102
First Posted: June 28, 2022    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared upon request and data use agreement must be signed
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Approximately 9 months after data completion
Access Criteria: De-identified data will be shared upon request with a data use agreement

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No