Trial Outcomes & Findings for Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccination (NCT NCT04893265)
NCT ID: NCT04893265
Last Updated: 2025-05-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
247 participants
Primary outcome timeframe
Week 16
Results posted on
2025-05-14
Participant Flow
Participants were recruited by 3 community-based agencies primarily through trained lay health workers.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
126
|
|
Overall Study
COMPLETED
|
119
|
117
|
|
Overall Study
NOT COMPLETED
|
2
|
9
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
Baseline Characteristics
6 participants with unknown age
Baseline characteristics by cohort
| Measure |
Text Messaging Only
n=121 Participants
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
|
INFORMED
n=126 Participants
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
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=119 Participants • 6 participants with unknown age
|
0 Participants
n=122 Participants • 6 participants with unknown age
|
0 Participants
n=241 Participants • 6 participants with unknown age
|
|
Age, Categorical
Between 18 and 65 years
|
98 Participants
n=119 Participants • 6 participants with unknown age
|
111 Participants
n=122 Participants • 6 participants with unknown age
|
209 Participants
n=241 Participants • 6 participants with unknown age
|
|
Age, Categorical
>=65 years
|
21 Participants
n=119 Participants • 6 participants with unknown age
|
11 Participants
n=122 Participants • 6 participants with unknown age
|
32 Participants
n=241 Participants • 6 participants with unknown age
|
|
Sex: Female, Male
Female
|
71 Participants
n=120 Participants • 1 participant did not provide sex
|
77 Participants
n=126 Participants • 1 participant did not provide sex
|
148 Participants
n=246 Participants • 1 participant did not provide sex
|
|
Sex: Female, Male
Male
|
49 Participants
n=120 Participants • 1 participant did not provide sex
|
49 Participants
n=126 Participants • 1 participant did not provide sex
|
98 Participants
n=246 Participants • 1 participant did not provide sex
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
0 Participants
n=126 Participants
|
0 Participants
n=247 Participants
|
|
Race (NIH/OMB)
Asian
|
121 Participants
n=121 Participants
|
126 Participants
n=126 Participants
|
247 Participants
n=247 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
0 Participants
n=126 Participants
|
0 Participants
n=247 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=121 Participants
|
0 Participants
n=126 Participants
|
0 Participants
n=247 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=121 Participants
|
0 Participants
n=126 Participants
|
0 Participants
n=247 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=121 Participants
|
0 Participants
n=126 Participants
|
0 Participants
n=247 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=126 Participants
|
0 Participants
n=247 Participants
|
|
Region of Enrollment
United States
|
121 participants
n=121 Participants
|
126 participants
n=126 Participants
|
247 participants
n=247 Participants
|
|
Participation mode
Individual
|
63 Participants
n=121 Participants
|
68 Participants
n=126 Participants
|
131 Participants
n=247 Participants
|
|
Participation mode
Dyad
|
58 Participants
n=121 Participants
|
58 Participants
n=126 Participants
|
116 Participants
n=247 Participants
|
|
Education
High School or Less/ Preferred Not to Answer
|
55 Participants
n=120 Participants • 1 participant did not respond
|
45 Participants
n=126 Participants • 1 participant did not respond
|
100 Participants
n=246 Participants • 1 participant did not respond
|
|
Education
Some college/ Technical or Vocational School
|
35 Participants
n=120 Participants • 1 participant did not respond
|
43 Participants
n=126 Participants • 1 participant did not respond
|
78 Participants
n=246 Participants • 1 participant did not respond
|
|
Education
Bachelor's Degree or Higher
|
30 Participants
n=120 Participants • 1 participant did not respond
|
38 Participants
n=126 Participants • 1 participant did not respond
|
68 Participants
n=246 Participants • 1 participant did not respond
|
|
Marital Status
Married/Living with Partner
|
69 Participants
n=119 Participants • 7 participants did not respond
|
83 Participants
n=121 Participants • 7 participants did not respond
|
152 Participants
n=240 Participants • 7 participants did not respond
|
|
Marital Status
Single/Preferred Not to Answer
|
50 Participants
n=119 Participants • 7 participants did not respond
|
38 Participants
n=121 Participants • 7 participants did not respond
|
88 Participants
n=240 Participants • 7 participants did not respond
|
|
Household Description
Family including kids
|
67 Participants
n=120 Participants • 1 participant did not answer
|
66 Participants
n=126 Participants • 1 participant did not answer
|
133 Participants
n=246 Participants • 1 participant did not answer
|
|
Household Description
Multigenerational
|
12 Participants
n=120 Participants • 1 participant did not answer
|
26 Participants
n=126 Participants • 1 participant did not answer
|
38 Participants
n=246 Participants • 1 participant did not answer
|
|
Household Description
No kids/Other
|
41 Participants
n=120 Participants • 1 participant did not answer
|
34 Participants
n=126 Participants • 1 participant did not answer
|
75 Participants
n=246 Participants • 1 participant did not answer
|
|
Asian cultural groups
Chinese
|
41 Participants
n=121 Participants
|
42 Participants
n=126 Participants
|
83 Participants
n=247 Participants
|
|
Asian cultural groups
Hmong
|
40 Participants
n=121 Participants
|
44 Participants
n=126 Participants
|
84 Participants
n=247 Participants
|
|
Asian cultural groups
Vietnamese
|
40 Participants
n=121 Participants
|
40 Participants
n=126 Participants
|
80 Participants
n=247 Participants
|
|
Nativity
Born outside of United States
|
86 Participants
n=118 Participants • 10 participants did not respond
|
93 Participants
n=119 Participants • 10 participants did not respond
|
179 Participants
n=237 Participants • 10 participants did not respond
|
|
Nativity
Born in the United States
|
32 Participants
n=118 Participants • 10 participants did not respond
|
26 Participants
n=119 Participants • 10 participants did not respond
|
58 Participants
n=237 Participants • 10 participants did not respond
|
|
Years lived in the United States
10 or fewer
|
26 Participants
n=117 Participants • 16 participants did not provide years lived in the U.S.
|
26 Participants
n=114 Participants • 16 participants did not provide years lived in the U.S.
|
52 Participants
n=231 Participants • 16 participants did not provide years lived in the U.S.
|
|
Years lived in the United States
More than 10 (including U.S. born)
|
91 Participants
n=117 Participants • 16 participants did not provide years lived in the U.S.
|
88 Participants
n=114 Participants • 16 participants did not provide years lived in the U.S.
|
179 Participants
n=231 Participants • 16 participants did not provide years lived in the U.S.
|
|
Preferred Language
English
|
69 Participants
n=121 Participants
|
74 Participants
n=126 Participants
|
143 Participants
n=247 Participants
|
|
Preferred Language
Non-English
|
52 Participants
n=121 Participants
|
52 Participants
n=126 Participants
|
104 Participants
n=247 Participants
|
|
Self-rated Spoken English Proficiency
Poorly/Not at all
|
37 Participants
n=120 Participants • 1 participant did not respond
|
33 Participants
n=126 Participants • 1 participant did not respond
|
70 Participants
n=246 Participants • 1 participant did not respond
|
|
Self-rated Spoken English Proficiency
So-so
|
26 Participants
n=120 Participants • 1 participant did not respond
|
22 Participants
n=126 Participants • 1 participant did not respond
|
48 Participants
n=246 Participants • 1 participant did not respond
|
|
Self-rated Spoken English Proficiency
Well/Fluently
|
57 Participants
n=120 Participants • 1 participant did not respond
|
71 Participants
n=126 Participants • 1 participant did not respond
|
128 Participants
n=246 Participants • 1 participant did not respond
|
|
Health insurance
Private Insurance
|
45 Participants
n=119 Participants • 3 participants did not respond
|
64 Participants
n=125 Participants • 3 participants did not respond
|
109 Participants
n=244 Participants • 3 participants did not respond
|
|
Health insurance
Other
|
74 Participants
n=119 Participants • 3 participants did not respond
|
61 Participants
n=125 Participants • 3 participants did not respond
|
135 Participants
n=244 Participants • 3 participants did not respond
|
|
Employment status
Currently working
|
67 Participants
n=119 Participants • 12 participants did not respond
|
74 Participants
n=116 Participants • 12 participants did not respond
|
141 Participants
n=235 Participants • 12 participants did not respond
|
|
Employment status
Not currently working
|
52 Participants
n=119 Participants • 12 participants did not respond
|
42 Participants
n=116 Participants • 12 participants did not respond
|
94 Participants
n=235 Participants • 12 participants did not respond
|
|
Self-rated Health
Excellent/Very Good/Good
|
99 Participants
n=120 Participants • 4 participants did not respond
|
109 Participants
n=123 Participants • 4 participants did not respond
|
208 Participants
n=243 Participants • 4 participants did not respond
|
|
Self-rated Health
Fair/Poor/DK/NA
|
21 Participants
n=120 Participants • 4 participants did not respond
|
14 Participants
n=123 Participants • 4 participants did not respond
|
35 Participants
n=243 Participants • 4 participants did not respond
|
|
Smoked cigarettes in the past 30 days
No
|
103 Participants
n=120 Participants • 4 participants did not respond
|
109 Participants
n=123 Participants • 4 participants did not respond
|
212 Participants
n=243 Participants • 4 participants did not respond
|
|
Smoked cigarettes in the past 30 days
Yes/DK/Preferred Not To Answer
|
17 Participants
n=120 Participants • 4 participants did not respond
|
14 Participants
n=123 Participants • 4 participants did not respond
|
31 Participants
n=243 Participants • 4 participants did not respond
|
|
Getting Tested for COVID-19 in the Past Month
No/Don't Know
|
95 Participants
n=120 Participants • 3 participants did not respond
|
95 Participants
n=124 Participants • 3 participants did not respond
|
190 Participants
n=244 Participants • 3 participants did not respond
|
|
Getting Tested for COVID-19 in the Past Month
Yes
|
25 Participants
n=120 Participants • 3 participants did not respond
|
29 Participants
n=124 Participants • 3 participants did not respond
|
54 Participants
n=244 Participants • 3 participants did not respond
|
|
Intention to get tested for COVID-19 as often as needed
No (do not agree)
|
41 Participants
n=118 Participants • 3 participants did not respond
|
42 Participants
n=126 Participants • 3 participants did not respond
|
83 Participants
n=244 Participants • 3 participants did not respond
|
|
Intention to get tested for COVID-19 as often as needed
Yes (agreed or strong agreed)
|
77 Participants
n=118 Participants • 3 participants did not respond
|
84 Participants
n=126 Participants • 3 participants did not respond
|
161 Participants
n=244 Participants • 3 participants did not respond
|
|
Decisional Conflict of Getting Tested for COVID-19 ("SURE" test)
|
3.61 units on a scale
STANDARD_DEVIATION 0.86 • n=119 Participants • 5 participants did not respond
|
3.55 units on a scale
STANDARD_DEVIATION 1.03 • n=123 Participants • 5 participants did not respond
|
3.58 units on a scale
STANDARD_DEVIATION 0.95 • n=242 Participants • 5 participants did not respond
|
|
Getting a COVID-19 test is easy
No (Do not agree)
|
22 Participants
n=119 Participants • 3 participants did not respond
|
18 Participants
n=125 Participants • 3 participants did not respond
|
40 Participants
n=244 Participants • 3 participants did not respond
|
|
Getting a COVID-19 test is easy
Yes (Agree / strongly agree)
|
97 Participants
n=119 Participants • 3 participants did not respond
|
107 Participants
n=125 Participants • 3 participants did not respond
|
204 Participants
n=244 Participants • 3 participants did not respond
|
|
Knew where to get COVID-19 testing
No (Do not agree)
|
28 Participants
n=117 Participants • 4 participants did not respond
|
21 Participants
n=126 Participants • 4 participants did not respond
|
49 Participants
n=243 Participants • 4 participants did not respond
|
|
Knew where to get COVID-19 testing
Yes (Agree / Strongly Agree)
|
89 Participants
n=117 Participants • 4 participants did not respond
|
105 Participants
n=126 Participants • 4 participants did not respond
|
194 Participants
n=243 Participants • 4 participants did not respond
|
|
Knew of people in family or social network who had been tested for COVID-19
No
|
15 Participants
n=120 Participants • 1 participant did not respond
|
13 Participants
n=126 Participants • 1 participant did not respond
|
28 Participants
n=246 Participants • 1 participant did not respond
|
|
Knew of people in family or social network who had been tested for COVID-19
Yes
|
105 Participants
n=120 Participants • 1 participant did not respond
|
113 Participants
n=126 Participants • 1 participant did not respond
|
218 Participants
n=246 Participants • 1 participant did not respond
|
|
Knowledge of COVID-19 test
|
4.58 units on a scale
STANDARD_DEVIATION 1.15 • n=121 Participants
|
4.75 units on a scale
STANDARD_DEVIATION 0.98 • n=126 Participants
|
4.67 units on a scale
STANDARD_DEVIATION 1.07 • n=247 Participants
|
|
Values about COVID-19 Testing
|
18.33 units on a scale
STANDARD_DEVIATION 2.76 • n=116 Participants • 13 participants did not respond or complete the measure
|
18.64 units on a scale
STANDARD_DEVIATION 2.02 • n=118 Participants • 13 participants did not respond or complete the measure
|
18.48 units on a scale
STANDARD_DEVIATION 2.42 • n=234 Participants • 13 participants did not respond or complete the measure
|
|
COVID-19 cases per 1000,000 population
|
846.08 cases per 100,000 population
STANDARD_DEVIATION 1261.78 • n=121 Participants
|
890.75 cases per 100,000 population
STANDARD_DEVIATION 1441.03 • n=126 Participants
|
868.87 cases per 100,000 population
STANDARD_DEVIATION 1353.62 • n=247 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Participants who completed the survey at Week 16 and provided all the information required to compute the variable.
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.
Outcome measures
| Measure |
Text Messaging Only
n=116 Participants
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
|
INFORMED
n=116 Participants
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
|
|---|---|---|
|
Decisional Conflict for Getting Tested for COVID-19
|
3.89 score on a scale
Standard Deviation 0.37
|
3.96 score on a scale
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: Week 16Participants are asked to self-report whether they have been tested for COVID-19 in the past 30 days
Outcome measures
| Measure |
Text Messaging Only
n=121 Participants
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
|
INFORMED
n=126 Participants
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
|
|---|---|---|
|
Tested for COVID-19 During the Past Month
Not Tested (or missing)
|
75 Participants
|
80 Participants
|
|
Tested for COVID-19 During the Past Month
Tested Tested
|
46 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Participants provided week 16 data
Proportion of participants who "agreed" or "strongly agreed" to the statement "I plan to get tested as often as needed."
Outcome measures
| Measure |
Text Messaging Only
n=116 Participants
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
|
INFORMED
n=116 Participants
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
|
|---|---|---|
|
COVID-19 Testing Intention
Agree/Strongly Agree
|
84 Participants
|
90 Participants
|
|
COVID-19 Testing Intention
Do not Agree
|
32 Participants
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 16Population: Participants who provided the outcome data at follow-up (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.
Outcome measures
| Measure |
Text Messaging Only
n=114 Participants
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
|
INFORMED
n=114 Participants
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
|
|---|---|---|
|
Decisional Conflicts for Getting Vaccinated for COVID-19 Score
|
3.87 score on a scale
Standard Deviation 0.47
|
3.98 score on a scale
Standard Deviation 0.13
|
Adverse Events
Text Messaging Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
INFORMED
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Janice Tsoh, PhD, Professor/ Principal Investigator
University of California San Francisco
Phone: 4155028438
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place