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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Educational Activities

Intervention / Treatment
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* Behavioral: Text Messaging Only
* Behavioral: INFORMED


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Text Messaging Only<br>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<br>* Active Comparator<br>|
| Experimental: INFORMED<br>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<br>* Experimental<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 Testing, COVID-19 Vaccination, Asian Americans, Peer Education, Immigrants, Chinese American, Hmong American, Vietnamese American