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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04893265
Recruitment Status : Recruiting
First Posted : May 19, 2021
Last Update Posted : February 24, 2022
Sponsor:
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

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.

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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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04893265


Contacts
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Contact: Janice Tsoh, PhD 415-502-8438 janice.tsoh@ucsf.edu
Contact: Edgar Yu, BS 415-476-7319 edgar.yu@ucsf.edu

Locations
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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
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Principal Investigator: Janice Y Tsoh, PhD University of California, San Francisco
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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    Key Record Dates
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.

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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:
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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