Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccination (INFORMED)

April 28, 2025 updated by: University of California, San Francisco
This study develops and evaluates the "INdividual and Family-Oriented Responsive Messaging EDucation" (INFORMED) intervention in increasing knowledge about COVID-19 testing and decreasing decisional conflicts of getting tested for COVID-19. A 2-arm randomized controlled trial will compare INFORMED delivered by LHW educational outreach plus Short Message Service (SMS) text messaging to SMS text with LHW support.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project "Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccinations" is to identify and address sociocultural, ethical and behavioral barriers related to Coronavirus Disease 2019 (COVID-19) testing and vaccination to enable Asian Americans to make well-informed decisions about getting tested for COVID-19. Asian Americans have experienced high rates of COVID-19 related hospitalization and mortality rates when compared to non-Hispanic whites particularly among those who tested positive. Excess COVID-19 related deaths observed in Asian Americans are in part due to under-testing or delayed testing. Asian Americans may face multiple challenges, including sociocultural (limited English proficiency, lack of trust, excess fears and social stigma related COVID-19), ethical (lack of proven benefits of various guidelines, unequal access to testing resources), and behavioral (tobacco and e-cigarette use, other competitive behaviors) factors. The pandemic is rapidly evolving and presents urgent needs to develop highly efficient channels to communicate accurate, easily comprehensive, cultural appropriate and practical information. This application is a supplement to a parent R01 "A Family-Focused Intervention for Asian American Male Smokers," as known to the public as a community-based intervention research program "Healthy Family Project." Leveraging the community partnerships and the individual / family-based LHW intervention approaches developed by the study team, the proposed aims are: (1)Develop and evaluate "INdividual and Family-Oriented Responsive Messaging EDucation" (INFORMED) intervention in increasing knowledge about COVID-19 testing and decreasing decisional conflicts of getting tested for COVID-19. A 2-arm randomized controlled trial will compare INFORMED delivered by LHW educational outreach plus SMS text messaging to SMS text with LHW support. (2) Conduct in-depth prospective investigation of sociocultural, ethical and behavioral factors related to COVID-19 testing in Chinese, Hmong and Vietnamese American over-time. In addition, factors affecting acceptance for vaccination research trial participation and vaccination uptake and how vaccination acceptance is associated with COVID-19 testing uptake will be explored.

Study Type

Interventional

Enrollment (Actual)

247

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93727
        • The Fresno Center
      • San Francisco, California, United States, 94133
        • Chinese Community Health Resource Center
      • San Jose, California, United States, 95110
        • Immigrant Resettlement & Cultural Center Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age 18 and older
  • self-identify as Chinese, Hmong or Vietnamese
  • able to read and/or speak: English, Chinese (Cantonese/Mandarin), Hmong or Vietnamese;
  • have access to a mobile phone to receive SMS text messages

Exclusion Criteria:

  • unwilling to receive SMS text messages from the project

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Text Messaging Only
Participants will receive a weekly SMS Text or instant message on a topic related to COVID-19 testing over 12 weeks. In addition, participants will receive as-needed messages on updates of COVID-19 testing related information. The messages will be responsive to the rapid evolving developments and changes related to COVID-19 testing guidelines. Some of the messages will include a link to allow participants to get to the entire message/information on the study website.
Behavioral: Text Messaging Only
Active Comparator
Experimental: INFORMED
Participants will receive a weekly SMS Text or instant message on a topic related to COVID-19 testing as described in the "Text Messaging Only." In addition, participants will receive a Lay Health Worker (LHW) Educational Outreach Program, which includes 2 group sessions via video calls like Zoom or another video conferencing platform and 2 follow-up contacts via telephone, text or other media assignment.
Behavioral: INFORMED
Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict for Getting Tested for COVID-19
Time Frame: Week 16
Decision conflict is measured by the 4-item Decision Making Conflict (SURE) test which asks whether participants: 1) know enough about benefits and harm; 2) clear about which benefits and harms matter most; 3) have enough support/advice to make a choice; and 4) feel sure about the best choice regarding getting tested for COVID-19. Each item is scored either 0 (unsure) or 1(sure). The total score ranges from 0 to 4. Higher scores indicate 'more sure,' lower scores indicate higher decisional conflict.
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tested for COVID-19 During the Past Month
Time Frame: Week 16
Participants are asked to self-report whether they have been tested for COVID-19 in the past 30 days
Week 16
COVID-19 Testing Intention
Time Frame: Week 16
Proportion of participants who "agreed" or "strongly agreed" to the statement "I plan to get tested as often as needed."
Week 16

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflicts for Getting Vaccinated for COVID-19 Score
Time Frame: Week 16
Decision conflicts is measured by the 4-item SURE test which asks whether participants: 1) know enough about benefits and harm; 2) clear about which benefits and harms matter most; 3) have enough support/advice to make a choice; and 4) feel sure about the best choice regarding getting vaccinated for COVID-19. Each item is scored either 0 (unsure) or 1 (sure). The total score ranges from 0 to 4. Higher score indicates lower decisional conflicts (or more sure); lower score indicates higher decisional conflicts.
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Drug Abuse (NIDA)
University of California, Davis
University of California, Merced
Chinese Community Health Resource Center

Investigators

  • Principal Investigator: Janice Y Tsoh, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Actual)

January 3, 2023

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-32933
  • 3R01DA036749-05S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared upon request and data use agreement must be signed.

IPD Sharing Time Frame

Approximately 9 months after data completion

IPD Sharing Access Criteria

De-identified data will be shared upon request with a data use agreement.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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