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

Educational Activities Clinical Trial

— INFORMED  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04893265
• Other study ID #: 20-32933
• Secondary ID: 3R01DA036749-05S
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: June 30, 2024

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 244
• Est. completion date: June 30, 2024
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Educational Activities

Intervention

Behavioral:
• Text Messaging Only
Active Comparator
• INFORMED
Experimental

Locations

Country	Name	City	State
United States	The Fresno Center	Fresno	California
United States	Chinese Community Health Resource Center	San Francisco	California
United States	Immigrant Resettlement & Cultural Center Inc	San Jose	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Chinese Community Health Resource Center, National Institute on Drug Abuse (NIDA), University of California, Davis, University of California, Merced

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of participants who have decisional conflicts for getting vaccinated for COVID-19	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.	Week 16
Primary	Proportion of participants who have decisional conflicts for getting tested of COVID-19	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.	Week 16
Secondary	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 16
Secondary	COVID-19 Testing Knowledge Score	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.	Week 16