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

Primary Purpose

Educational Activities

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Messaging Only
INFORMED
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Educational Activities focused on measuring COVID-19 Testing, COVID-19 Vaccination, Asian Americans, Peer Education, Immigrants, Chinese American, Hmong American, Vietnamese American

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Fresno Center
  • Chinese Community Health Resource Center
  • Immigrant Resettlement & Cultural Center Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Text Messaging Only

INFORMED

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 17, 2021
Last Updated
January 9, 2023
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)
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1. Study Identification

Unique Protocol Identification Number
NCT04893265
Brief Title
Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccination
Acronym
INFORMED
Official Title
Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Educational Activities
Keywords
COVID-19 Testing, COVID-19 Vaccination, Asian Americans, Peer Education, Immigrants, Chinese American, Hmong American, Vietnamese American

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text Messaging Only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
INFORMED
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text Messaging Only
Intervention Description
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
INFORMED
Intervention Description
Experimental
Primary Outcome Measure Information:
Title
Proportion of participants who have decisional conflicts for getting tested of COVID-19
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Proportion of participants who has been tested for COVID-19 during the study period.
Description
Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program.
Time Frame
Week 16
Title
COVID-19 Testing Knowledge Score
Description
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.
Time Frame
Week 16
Other Pre-specified Outcome Measures:
Title
Proportion of participants who have decisional conflicts for getting vaccinated for COVID-19
Description
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.
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Y Tsoh, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fresno Center
City
Fresno
State/Province
California
ZIP/Postal Code
93727
Country
United States
Facility Name
Chinese Community Health Resource Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94133
Country
United States
Facility Name
Immigrant Resettlement & Cultural Center Inc
City
San Jose
State/Province
California
ZIP/Postal Code
95110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared upon request and data use agreement must be signed.
IPD Sharing Time Frame
Approximately 9 months after data completion
IPD Sharing Access Criteria
De-identified data will be shared upon request with a data use agreement.

Learn more about this trial

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

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