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

Sponsor
University of California, San Francisco (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04893265
Collaborator
Chinese Community Health Resource Center (Other), University of California, Davis (Other), University of California, Merced (Other), National Institute on Drug Abuse (NIDA) (NIH)
244
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2
13
81.3
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Study Details

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
  • Behavioral: Text Messaging Only
  • Behavioral: INFORMED
N/A

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
Actual Enrollment :
244 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized trialRandomized 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 :
Sep 30, 2021
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 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 [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. [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 The Fresno Center Fresno California United States 93727
2 Chinese Community Health Resource Center San Francisco California United States 94133
3 Immigrant Resettlement & Cultural Center Inc 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT04893265
Other Study ID Numbers:
  • 20-32933
  • 3R01DA036749-05S1
First Posted:
May 19, 2021
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022