Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 3R01DA036749-05S1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chinese Community Health Resource Center | OTHER |
| University of California, Davis | OTHER |
| University of California, Merced | OTHER |
| National Institute on Drug Abuse (NIDA) |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Messaging Only | Behavioral | Active Comparator |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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." |
| Measure | Description | Time Frame |
|---|---|---|
| Decisional Conflicts for Getting Vaccinated for COVID-19 Score | 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 (unsure) or 1 (sure). The total score ranges from 0 to 4. Higher score indicates lower decisional conflicts (or more sure); lower score indicates higher decisional conflicts. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janice Y Tsoh, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fresno Center | Fresno | California | 93727 | United States | ||
| Chinese Community Health Resource Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36108257 | Background | 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. |
Not provided
Not provided
De-identified data will be shared upon request and data use agreement must be signed.
Approximately 9 months after data completion
De-identified data will be shared upon request with a data use agreement.
Not provided
Participants much complete baseline survey prior to randomization and assignment intervention groups. Participants could choose to participate as a dyad with another participant or participate individually. If the participants choose to participate as a dyad, both participants were randomized together in the same group. All data tables represent individual participants.
Participants were recruited by 3 community-based agencies primarily through trained lay health workers.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Text Messaging Only: Active Comparator |
| FG001 | 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. INFORMED: Experimental |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Text Messaging Only: Active Comparator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 6 participants with unknown age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who completed the survey at Week 16 and provided all the information required to compute the variable. | Posted | Mean | Standard Deviation | score on a scale | Week 16 |
|
16 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Text Messaging Only: Active Comparator |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janice Tsoh, PhD, Professor/ Principal Investigator | University of California San Francisco | 4155028438 | janice.tsoh@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2025 | Apr 25, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2022 | Mar 17, 2025 | ICF_001.pdf |
Not provided
| NIH |
Randomized trial
Not provided
Not provided
Not provided
Not provided
| INFORMED |
| Behavioral |
Experimental |
|
| Week 16 |
| Week 16 |
| San Francisco |
| California |
| 94133 |
| United States |
| Immigrant Resettlement & Cultural Center Inc | San Jose | California | 95110 | United States |
| BG001 | 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. INFORMED: Experimental |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 1 participant did not provide sex | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participation mode | Participants could choose to participate as a dyad with another participant, or to participate individually. If the participants choose to participate as a dyad both participants were randomized to the same treatment condition. | Count of Participants | Participants |
|
| Education | Categorical | 1 participant did not respond | Count of Participants | Participants |
|
| Marital Status | 7 participants did not respond | Count of Participants | Participants |
|
| Household Description | 1 participant did not answer | Count of Participants | Participants |
|
| Asian cultural groups | Count of Participants | Participants |
|
| Nativity | 10 participants did not respond | Count of Participants | Participants |
|
| Years lived in the United States | 16 participants did not provide years lived in the U.S. | Count of Participants | Participants |
|
| Preferred Language | Count of Participants | Participants |
|
| Self-rated Spoken English Proficiency | 1 participant did not respond | Count of Participants | Participants |
|
| Health insurance | 3 participants did not respond | Count of Participants | Participants |
|
| Employment status | 12 participants did not respond | Count of Participants | Participants |
|
| Self-rated Health | 4 participants did not respond | Count of Participants | Participants |
|
| Smoked cigarettes in the past 30 days | 4 participants did not respond | Count of Participants | Participants |
|
| Getting Tested for COVID-19 in the Past Month | 3 participants did not respond | Count of Participants | Participants |
|
| Intention to get tested for COVID-19 as often as needed | 3 participants did not respond | Count of Participants | Participants |
|
| Decisional Conflict of Getting Tested for COVID-19 ("SURE" test) | 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. | 5 participants did not respond | Mean | Standard Deviation | units on a scale |
|
| Getting a COVID-19 test is easy | 3 participants did not respond | Count of Participants | Participants |
|
| Knew where to get COVID-19 testing | 4 participants did not respond | Count of Participants | Participants |
|
| Knew of people in family or social network who had been tested for COVID-19 | 1 participant did not respond | Count of Participants | Participants |
|
| Knowledge of COVID-19 test | The COVID-19 Test Knowledge Scale consists of 6 true-false items testing knowledge about interpretations related to positive or negative COVID-19 test results. The score is the sum of items that a participant answers correctly, ranged from 0 (no item was responded correctly) to 6 (all items were responded correctly). | Mean | Standard Deviation | units on a scale |
|
| Values about COVID-19 Testing | This is a 4-item scale asking participants to indicate their values or attitudes toward getting COVID-19 tested using on a 5-point scale (1 to 5) for each set of attributes: bad to good; unimportant to important; not reassuring to reassuring; a difficult decision to an easy decision. The scale score is computed by summing the score of all 4 items, ranged from 4 to 20. | 13 participants did not respond or complete the measure | Mean | Standard Deviation | units on a scale |
|
| COVID-19 cases per 1000,000 population | Number of COVID-19 cases per 100,000 population recorded within the past 30 days matched to individual participants' county of residence and time of baseline survey completion. Source of data: California Department of Public Health: COVID-19 Time-Series Metrics by County and State (ARCHIVED). Available at: https://data.chhs.ca.gov/dataset/covid-19-time-series-metrics-by-county-and-state. | Mean | Standard Deviation | cases per 100,000 population |
|
| OG001 | 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. INFORMED: Experimental |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Week 16 |
|
|
|
|
| Secondary | COVID-19 Testing Intention | Proportion of participants who "agreed" or "strongly agreed" to the statement "I plan to get tested as often as needed." | Participants provided week 16 data | Posted | Count of Participants | Participants | Week 16 |
|
|
|
|
| Other Pre-specified | Decisional Conflicts for Getting Vaccinated for COVID-19 Score | 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 (unsure) or 1 (sure). The total score ranges from 0 to 4. Higher score indicates lower decisional conflicts (or more sure); lower score indicates higher decisional conflicts. | Participants who provided the outcome data at follow-up (week 16) | Posted | Mean | Standard Deviation | score on a scale | Week 16 |
|
|
|
|
| 0 |
| 121 |
| 0 |
| 121 |
| 0 |
| 121 |
| EG001 | 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. INFORMED: Experimental | 0 | 126 | 0 | 126 | 0 | 126 |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Bachelor's Degree or Higher |
|
| No kids/Other |
|
| Vietnamese |
|
| Well/Fluently |
|