Educational ActivitiesINFORMEDNCT04893265
Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccination
A study testing Text Messaging Only and INFORMED in people with Educational Activities, run by University of California, San Francisco at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Educational Activities
- What is being tested?
- Text Messaging Only and INFORMED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Sep 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unwilling to receive SMS text messages from the project
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Fresno Center
Fresno, California, 93727
Chinese Community Health Resource Center
San Francisco, California, 94133
Immigrant Resettlement & Cultural Center Inc
San Jose, California, 95110
About this study
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.
Read the 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.
- Conditions
- Educational Activities
- Being tested
- Text Messaging Only, INFORMED
- Keywords
- COVID-19 Testing, COVID-19 Vaccination, Asian Americans, Peer Education, Immigrants, Chinese American, Hmong American, Vietnamese American
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Messaging OnlyBehavioural
Active Comparator
INFORMEDBehavioural
Experimental
| Study group | Role | What they receive |
|---|---|---|
| Text Messaging Only | Active comparator | 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. Receives: Behavioral: Text Messaging Only |
| INFORMED | Experimental | 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. Receives: Behavioral: INFORMED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict for Getting Tested for COVID-19
Decision conflict 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 (unsure) or 1(sure). The total score ranges from 0 to 4. Higher scores indicate 'more sure,' lower scores indicate higher decisional conflict.
Measured: Week 16
Secondary outcomes (2)
Tested for COVID-19 During the Past Month
Participants are asked to self-report whether they have been tested for COVID-19 in the past 30 days
Measured: Week 16
COVID-19 Testing Intention
Proportion of participants who "agreed" or "strongly agreed" to the statement "I plan to get tested as often as needed."
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start30 Sep 2021
- Primary completion3 Jan 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Educational ActivitiesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Community Health Resource Center, University of California, Davis, University of California, Merced, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Janice Y Tsoh, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893265
- Sponsor's protocol ID
- 20-32933
- Other IDs
- 3R01DA036749-05S1
- Acronym
- INFORMED
- Status last verified
- Apr 2025
- First submitted
- 17 May 2021
- Last updated
- 14 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared upon request and data use agreement must be signed.
Publications
Cheng J, Tsoh JY, Guan A, Luu M, Nguyen IV, Tan R, Thao C, Yu E, Lor D, Pham M, Choi J, Kim M, Stewart SL, Burke NJ. Engaging Asian American Communities During the COVID-19 Era Tainted With Anti-Asian Hate and Distrust. Am J Public Health. 2022 Nov;112(S9):S864-S868. doi: 10.2105/AJPH.2022.306952. Epub 2022 Sep 15. No abstract available.
PubMed 36108257
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccination
- ClinicalTrials.gov ID
- NCT04893265
- Acronym / sponsor ID
- INFORMED / 20-32933
- Conditions
- Educational Activities
- Keywords
- COVID-19 Testing, COVID-19 Vaccination, Asian Americans, Peer Education, Immigrants, Chinese American, Hmong American, Vietnamese American
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Chinese Community Health Resource Center, University of California, Davis, University of California, Merced, National Institute on Drug Abuse (NIDA)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized trial
| Arm | Type | Receives |
|---|---|---|
| Text Messaging Only | Active comparator | Behavioral: Text Messaging OnlyParticipants 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. |
| INFORMED | Experimental | Behavioral: INFORMEDParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- unwilling to receive SMS text messages from the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Messaging OnlyActive Comparator | Behavioural | Text Messaging Only |
| INFORMEDExperimental | Behavioural | INFORMED |
Primary outcome
Decisional Conflict for Getting Tested for COVID-19
Time frame: Week 16
Decision conflict 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 (unsure) or 1(sure). The total score ranges from 0 to 4. Higher scores indicate 'more sure,' lower scores indicate higher decisional conflict.
2 secondary outcomes
Tested for COVID-19 During the Past Month
Time frame: Week 16
COVID-19 Testing Intention
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36108257Cheng J, Tsoh JY, Guan A, Luu M, Nguyen IV, Tan R, Thao C, Yu E, Lor D, Pham M, Choi J, Kim M, Stewart SL, Burke NJ. Engaging Asian American Communities During the COVID-19 Era Tainted With Anti-Asian Hate and Distrust. Am J Public Health. 2022 Nov;112(S9):S864-S868. doi: 10.2105/AJPH.2022.306952. Epub 2022 Sep 15. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified data will be shared upon request and data use agreement must be signed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Y Tsoh, PhD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging Only and INFORMED in people with Educational Activities, run by University of California, San Francisco at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict for Getting Tested for COVID-19 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04893265, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.