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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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