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

NCT04893265 | Completed Results DMC

• 2 other identifiers: 20-329333R01DA036749-05S1
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Educational Activities

Keywords

COVID-19 Testing; COVID-19 Vaccination; Asian Americans; Peer Education; Immigrants; Chinese American; Hmong American; Vietnamese American

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict for Getting Tested for COVID-19

  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 Outcomes (2)

• Tested for COVID-19 During the Past Month

  Week 16

• COVID-19 Testing Intention

  Week 16

Other Outcomes (1)

• Decisional Conflicts for Getting Vaccinated for COVID-19 Score

  Week 16

Study Arms (2)

Text Messaging Only

ACTIVE COMPARATOR

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

INFORMED

EXPERIMENTAL

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

Interventions

Text Messaging Only BEHAVIORAL

Active Comparator

Text Messaging Only

INFORMED BEHAVIORAL

Experimental

INFORMED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unwilling to receive SMS text messages from the project

Sponsors & Collaborators

• University of California, San Francisco: lead
• Chinese Community Health Resource Center: collaborator
• University of California, Davis: collaborator
• University of California, Merced: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

The Fresno Center

Fresno, California, 93727, United States

Location

Chinese Community Health Resource Center

San Francisco, California, 94133, United States

Location

Immigrant Resettlement & Cultural Center Inc

San Jose, California, 95110, United States

Location

Related Publications (1)

• Cheng J, Tsoh JY, Guan A, Luu M, Nguyen IV, Tan R, Thao C, Yu E, Lor D, Pham M, Choi J, Kim M, Stewart SL, Burke NJ. Engaging Asian American Communities During the COVID-19 Era Tainted With Anti-Asian Hate and Distrust. Am J Public Health. 2022 Nov;112(S9):S864-S868. doi: 10.2105/AJPH.2022.306952. Epub 2022 Sep 15. No abstract available.

  PMID: 36108257 BACKGROUND

Results Point of Contact

• Title: Janice Tsoh, PhD, Professor/ Principal Investigator
• Organization: University of California San Francisco

janice.tsoh@ucsf.edu

4155028438

Study Officials

• Janice Y Tsoh, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized trial

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 19, 2021
• Study Start: September 30, 2021
• Primary Completion: January 3, 2023
• Study Completion: June 30, 2024
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Approximately 9 months after data completion
• Access Criteria: De-identified data will be shared upon request with a data use agreement.

Locations

US (3)