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

• ClinicalTrials.gov Identifier: NCT04893265
• Recruitment Status: Recruiting
• First Posted: May 19, 2021
• Last Update Posted: February 24, 2022
• Sponsor: University of California, San Francisco
• Collaborators: Chinese Community Health Resource Center; University of California, Davis; University of California, Merced; National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Educational Activities	Behavioral: Text Messaging Only; Behavioral: INFORMED	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccination
• Actual Study Start Date: September 30, 2021
• Estimated Primary Completion Date: October 30, 2022
• Estimated Study Completion Date: October 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Proportion of participants who have decisional conflicts for getting tested of COVID-19 [ Time Frame: Week 16 ]
   Decision conflicts 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 or 1. The total score ranges from 0 to 4. A score at 3 or lower is considered as having some decisional conflict.

Secondary Outcome Measures :

1. Proportion of participants who has been tested for COVID-19 during the study period. [ Time Frame: Week 16 ]
   Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program.
2. COVID-19 Testing Knowledge Score [ Time Frame: Week 16 ]
   The knowledge scale includes 7 items about what a positive and a negative test result means. The total score correspond to the number of items answered correctly, which ranges from 0 to 7.

Other Outcome Measures:

1. Proportion of participants who have decisional conflicts for getting vaccinated for COVID-19 [ 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 or 1. The total score ranges from 0 to 4. A score at 3 or lower is considered as having some decisional conflict.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Janice Tsoh, PhD; 415-502-8438; janice.tsoh@ucsf.edu

Contact: Edgar Yu, BS; 415-476-7319; edgar.yu@ucsf.edu

Locations

United States, California

The Fresno Center; Recruiting

Fresno, California, United States, 93727

Contact: Dao Lor 559-255-8395 dao.lor@fresnocenter.org

Chinese Community Health Resource Center; Enrolling by invitation

San Francisco, California, United States, 94133

Immigrant Resettlement & Cultural Center Inc; Enrolling by invitation

San Jose, California, United States, 95110

Sponsors and Collaborators

University of California, San Francisco

Chinese Community Health Resource Center

University of California, Davis

University of California, Merced

National Institute on Drug Abuse (NIDA)

Investigators

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

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04893265
• Other Study ID Numbers: 20-32933; 3R01DA036749-05S1 ( U.S. NIH Grant/Contract )
• First Posted: May 19, 2021
• Last Update Posted: February 24, 2022
• Last Verified: February 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:

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

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases