An interventional study of Text Messaging Only and INFORMED in Educational Activities, sponsored by University of California, San Francisco. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 247 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Active Comparator
Experimental
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.
Time frame: Week 16
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
Time frame: 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."
Time frame: Week 16
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.
Time frame: Week 16
Participants were recruited by 3 community-based agencies primarily through trained lay health workers.
| Milestone | Text Messaging Only | INFORMED |
|---|---|---|
| Started | 121 | 126 |
| Completed | 119 | 117 |
| Not completed | 2 | 9 |
| Withdrew: Withdrawal by subject | 2 | 5 |
| Withdrew: Lost to follow-up | 0 | 4 |
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.
| score on a scale | Text Messaging Only | INFORMED |
|---|---|---|
| Decisional Conflict for Getting Tested for COVID-19 | 3.89 ± 0.37 | 3.96 ± 0.24 |
Participants are asked to self-report whether they have been tested for COVID-19 in the past 30 days
| Participants | Text Messaging Only | INFORMED |
|---|---|---|
| Tested Tested | 46 | 46 |
| Not Tested (or missing) | 75 | 80 |
Proportion of participants who "agreed" or "strongly agreed" to the statement "I plan to get tested as often as needed."
| Participants | Text Messaging Only | INFORMED |
|---|---|---|
| Agree/Strongly Agree | 84 | 90 |
| Do not Agree | 32 | 26 |
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.
| score on a scale | Text Messaging Only | INFORMED |
|---|---|---|
| Decisional Conflicts for Getting Vaccinated for COVID-19 Score | 3.87 ± 0.47 | 3.98 ± 0.13 |
Collected over 16 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Text Messaging Only | 0/121 (0%) | 0/121 (0%) | 0/121 (0%) |
| INFORMED | 0/126 (0%) | 0/126 (0%) | 0/126 (0%) |
| Age, Categorical(Participants) | Text Messaging Only | INFORMED | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 98 | 111 | 209 |
| >=65 years | 21 | 11 | 32 |
| Sex: Female, Male(Participants) | Text Messaging Only | INFORMED | Total |
|---|---|---|---|
| Female | 71 | 77 | 148 |
| Male | 49 | 49 | 98 |
| Race (NIH/OMB)(Participants) | Text Messaging Only | INFORMED | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 121 | 126 | 247 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Text Messaging Only | INFORMED | Total |
|---|---|---|---|
| United States | 121 | 126 | 247 |
| Participation mode(Participants) | Text Messaging Only | INFORMED | Total |
|---|---|---|---|
| Individual | 63 | 68 | 131 |
| Dyad | 58 | 58 | 116 |
| Education(Participants) | Text Messaging Only | INFORMED | Total |
|---|---|---|---|
| High School or Less/ Preferred Not to Answer | 55 | 45 | 100 |
| Some college/ Technical or Vocational School | 35 | 43 | 78 |
| Bachelor's Degree or Higher | 30 | 38 | 68 |
| Marital Status(Participants) | Text Messaging Only | INFORMED | Total |
|---|---|---|---|
| Married/Living with Partner | 69 | 83 | 152 |
| Single/Preferred Not to Answer | 50 | 38 | 88 |
| Household Description(Participants) | Text Messaging Only | INFORMED | Total |
|---|---|---|---|
| Family including kids | 67 | 66 | 133 |
| Multigenerational | 12 | 26 | 38 |
| No kids/Other | 41 | 34 | 75 |
18 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified data will be shared upon request and data use agreement must be signed.
Supporting information: Icf
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco