Educational Activities
Conditions
Keywords
COVID-19 Testing, COVID-19 Vaccination, Asian Americans, Peer Education, Immigrants, Chinese American, Hmong American, Vietnamese American
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.
Interventions
BEHAVIORALText Messaging Only
Active Comparator
BEHAVIORALINFORMED
Experimental
Sponsors
Chinese Community Health Resource Center
University of California, Davis
University of California, Merced
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict for Getting Tested for COVID-19 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tested for COVID-19 During the Past Month | Week 16 | Participants are asked to self-report whether they have been tested for COVID-19 in the past 30 days |
| COVID-19 Testing Intention | Week 16 | Proportion of participants who agreed or strongly agreed to the statement I plan to get tested as often as needed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflicts for Getting Vaccinated for COVID-19 Score | Week 16 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited by 3 community-based agencies primarily through trained lay health workers.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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 | 121 |
| 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 | 126 |
| Total | 247 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | INFORMED | Text Messaging Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 21 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 111 Participants | 98 Participants | 209 Participants |
| Asian cultural groups Chinese | 42 Participants | 41 Participants | 83 Participants |
| Asian cultural groups Hmong | 44 Participants | 40 Participants | 84 Participants |
| Asian cultural groups Vietnamese | 40 Participants | 40 Participants | 80 Participants |
| COVID-19 cases per 1000,000 population | 890.75 cases per 100,000 population STANDARD_DEVIATION 1441.03 | 846.08 cases per 100,000 population STANDARD_DEVIATION 1261.78 | 868.87 cases per 100,000 population STANDARD_DEVIATION 1353.62 |
| Decisional Conflict of Getting Tested for COVID-19 (SURE test) | 3.55 units on a scale STANDARD_DEVIATION 1.03 | 3.61 units on a scale STANDARD_DEVIATION 0.86 | 3.58 units on a scale STANDARD_DEVIATION 0.95 |
| Education Bachelor's Degree or Higher | 38 Participants | 30 Participants | 68 Participants |
| Education High School or Less/ Preferred Not to Answer | 45 Participants | 55 Participants | 100 Participants |
| Education Some college/ Technical or Vocational School | 43 Participants | 35 Participants | 78 Participants |
| Employment status Currently working | 74 Participants | 67 Participants | 141 Participants |
| Employment status Not currently working | 42 Participants | 52 Participants | 94 Participants |
| Getting a COVID-19 test is easy No (Do not agree) | 18 Participants | 22 Participants | 40 Participants |
| Getting a COVID-19 test is easy Yes (Agree / strongly agree) | 107 Participants | 97 Participants | 204 Participants |
| Getting Tested for COVID-19 in the Past Month No/Don't Know | 95 Participants | 95 Participants | 190 Participants |
| Getting Tested for COVID-19 in the Past Month Yes | 29 Participants | 25 Participants | 54 Participants |
| Health insurance Other | 61 Participants | 74 Participants | 135 Participants |
| Health insurance Private Insurance | 64 Participants | 45 Participants | 109 Participants |
| Household Description Family including kids | 66 Participants | 67 Participants | 133 Participants |
| Household Description Multigenerational | 26 Participants | 12 Participants | 38 Participants |
| Household Description No kids/Other | 34 Participants | 41 Participants | 75 Participants |
| Intention to get tested for COVID-19 as often as needed No (do not agree) | 42 Participants | 41 Participants | 83 Participants |
| Intention to get tested for COVID-19 as often as needed Yes (agreed or strong agreed) | 84 Participants | 77 Participants | 161 Participants |
| Knew of people in family or social network who had been tested for COVID-19 No | 13 Participants | 15 Participants | 28 Participants |
| Knew of people in family or social network who had been tested for COVID-19 Yes | 113 Participants | 105 Participants | 218 Participants |
| Knew where to get COVID-19 testing No (Do not agree) | 21 Participants | 28 Participants | 49 Participants |
| Knew where to get COVID-19 testing Yes (Agree / Strongly Agree) | 105 Participants | 89 Participants | 194 Participants |
| Knowledge of COVID-19 test | 4.75 units on a scale STANDARD_DEVIATION 0.98 | 4.58 units on a scale STANDARD_DEVIATION 1.15 | 4.67 units on a scale STANDARD_DEVIATION 1.07 |
| Marital Status Married/Living with Partner | 83 Participants | 69 Participants | 152 Participants |
| Marital Status Single/Preferred Not to Answer | 38 Participants | 50 Participants | 88 Participants |
| Nativity Born in the United States | 26 Participants | 32 Participants | 58 Participants |
| Nativity Born outside of United States | 93 Participants | 86 Participants | 179 Participants |
| Participation mode Dyad | 58 Participants | 58 Participants | 116 Participants |
| Participation mode Individual | 68 Participants | 63 Participants | 131 Participants |
| Preferred Language English | 74 Participants | 69 Participants | 143 Participants |
| Preferred Language Non-English | 52 Participants | 52 Participants | 104 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 126 Participants | 121 Participants | 247 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 126 participants | 121 participants | 247 participants |
| Self-rated Health Excellent/Very Good/Good | 109 Participants | 99 Participants | 208 Participants |
| Self-rated Health Fair/Poor/DK/NA | 14 Participants | 21 Participants | 35 Participants |
| Self-rated Spoken English Proficiency Poorly/Not at all | 33 Participants | 37 Participants | 70 Participants |
| Self-rated Spoken English Proficiency So-so | 22 Participants | 26 Participants | 48 Participants |
| Self-rated Spoken English Proficiency Well/Fluently | 71 Participants | 57 Participants | 128 Participants |
| Sex: Female, Male Female | 77 Participants | 71 Participants | 148 Participants |
| Sex: Female, Male Male | 49 Participants | 49 Participants | 98 Participants |
| Smoked cigarettes in the past 30 days No | 109 Participants | 103 Participants | 212 Participants |
| Smoked cigarettes in the past 30 days Yes/DK/Preferred Not To Answer | 14 Participants | 17 Participants | 31 Participants |
| Values about COVID-19 Testing | 18.64 units on a scale STANDARD_DEVIATION 2.02 | 18.33 units on a scale STANDARD_DEVIATION 2.76 | 18.48 units on a scale STANDARD_DEVIATION 2.42 |
| Years lived in the United States 10 or fewer | 26 Participants | 26 Participants | 52 Participants |
| Years lived in the United States More than 10 (including U.S. born) | 88 Participants | 91 Participants | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 126 |
| other Total, other adverse events | 0 / 121 | 0 / 126 |
| serious Total, serious adverse events | 0 / 121 | 0 / 126 |
Outcome results
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.
Time frame: Week 16
Population: Participants who completed the survey at Week 16 and provided all the information required to compute the variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Text Messaging Only | Decisional Conflict for Getting Tested for COVID-19 | 3.89 score on a scale | Standard Deviation 0.37 |
| INFORMED | Decisional Conflict for Getting Tested for COVID-19 | 3.96 score on a scale | Standard Deviation 0.24 |
p-value: 0.447195% CI: [-0.1352, 0.306]Mixed Models Analysis
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.
Time frame: Week 16
Population: Participants provided week 16 data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text Messaging Only | COVID-19 Testing Intention | Agree/Strongly Agree | 84 Participants |
| Text Messaging Only | COVID-19 Testing Intention | Do not Agree | 32 Participants |
| INFORMED | COVID-19 Testing Intention | Agree/Strongly Agree | 90 Participants |
| INFORMED | COVID-19 Testing Intention | Do not Agree | 26 Participants |
p-value: <0.0595% CI: [0.6166, 3.3192]Mixed Models Analysis
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
Time frame: Week 16
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text Messaging Only | Tested for COVID-19 During the Past Month | Not Tested (or missing) | 75 Participants |
| Text Messaging Only | Tested for COVID-19 During the Past Month | Tested Tested | 46 Participants |
| INFORMED | Tested for COVID-19 During the Past Month | Tested Tested | 46 Participants |
| INFORMED | Tested for COVID-19 During the Past Month | Not Tested (or missing) | 80 Participants |
p-value: <0.0595% CI: [0.4284, 1.6385]Mixed Models Analysis
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.
Time frame: Week 16
Population: Participants who provided the outcome data at follow-up (week 16)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Text Messaging Only | Decisional Conflicts for Getting Vaccinated for COVID-19 Score | 3.87 score on a scale | Standard Deviation 0.47 |
| INFORMED | Decisional Conflicts for Getting Vaccinated for COVID-19 Score | 3.98 score on a scale | Standard Deviation 0.13 |
95% CI: [-0.07311, 0.2463]