Trial Outcomes & Findings for Culturally-Targeted COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake (NCT NCT04957082)
NCT ID: NCT04957082
Last Updated: 2024-06-28
Results Overview
Number (Percentage) of participants who respond "yes" to be included in offer to participate in no cost SAR-CoV-2 salivary antibody test.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
666 participants
Primary outcome timeframe
Immediately following didactic study portion and health communication randomization on day 1.
Results posted on
2024-06-28
Participant Flow
Participant milestones
| Measure |
White Flint Registry: General
White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: General
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: Culturally Targeted
African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.
Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans.
|
|---|---|---|---|
|
Overall Study
STARTED
|
229
|
207
|
230
|
|
Overall Study
COMPLETED
|
198
|
128
|
161
|
|
Overall Study
NOT COMPLETED
|
31
|
79
|
69
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Culturally-Targeted COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake
Baseline characteristics by cohort
| Measure |
White Flint Registry: General
n=198 Participants
White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: General
n=128 Participants
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: Culturally Targeted
n=161 Participants
African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.
Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans.
|
Total
n=487 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
168 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
423 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
277 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
190 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
474 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
289 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
198 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
198 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Immediately following didactic study portion and health communication randomization on day 1.Population: Number (percentage) of participants in each condition who opted to participate in salivary antibody testing.
Number (Percentage) of participants who respond "yes" to be included in offer to participate in no cost SAR-CoV-2 salivary antibody test.
Outcome measures
| Measure |
White Flint Registry: General
n=198 Participants
White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: General
n=128 Participants
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: Culturally Targeted
n=161 Participants
African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.
Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans.
|
|---|---|---|---|
|
Number (Percentage) of Participants Requested to Participate in Saliva-based SARS-CoV-2 Antibody Testing
|
175 Participants
|
84 Participants
|
121 Participants
|
PRIMARY outcome
Timeframe: 8 weeks from the day of consenting to participate in the salivary-based SARS-CoV-2 antibody testingNumber (Percentage) of participants that requested to participate in antibody testing who actually complete antibody testing.
Outcome measures
| Measure |
White Flint Registry: General
n=175 Participants
White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: General
n=84 Participants
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: Culturally Targeted
n=121 Participants
African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.
Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans.
|
|---|---|---|---|
|
Number (Percentage) of Participants Who Requested Saliva-based SARS-CoV-2 Antibody Testing Participated in the Testing.
|
111 Participants
|
55 Participants
|
79 Participants
|
PRIMARY outcome
Timeframe: Immediately following didactic study portion and health communication randomization on day 1.Population: All participants for whom Theory of Planned Behavior measure was successfully recorded immediately following messaging randomization.
Submeasure of Theory of Planned Behavior Indicating extent of a favorable attitude SARS-CoV-2 towards antibody testing (Seven point Likert Rating, with higher scores indicating more favorable Attitudes).
Outcome measures
| Measure |
White Flint Registry: General
n=198 Participants
White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: General
n=128 Participants
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: Culturally Targeted
n=161 Participants
African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.
Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans.
|
|---|---|---|---|
|
SARS-CoV-2 Antibody Testing Attitudes
|
5.91 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.13
|
5.61 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.31
|
5.71 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.22
|
PRIMARY outcome
Timeframe: Immediately following didactic study portion and health communication randomization on day 1.Population: All participants for whom Theory of Planned Behavior measure was successfully recorded immediately following messaging randomization.
Sub-measure of Theory of Planned Behavior Indicating extent to which believes other people are favorable towards SARS-CoV-2 towards antibody testing (Seven point Likert Rating, with higher scores indicating stronger Normative Beliefs).
Outcome measures
| Measure |
White Flint Registry: General
n=198 Participants
White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: General
n=128 Participants
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: Culturally Targeted
n=161 Participants
African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.
Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans.
|
|---|---|---|---|
|
SARS-CoV-2 Antibody Testing Normative Beliefs
|
4.71 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.38
|
4.69 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.41
|
4.85 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.45
|
PRIMARY outcome
Timeframe: Immediately following didactic study portion and health communication randomization on day 1.Sub-measure of Theory of Planned Behavior Indicating Self Efficacy to Complete Antibody Testing (Seven point Likert Rating, with higher scores indicating greater Perceived Behavioral Control).
Outcome measures
| Measure |
White Flint Registry: General
n=198 Participants
White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: General
n=128 Participants
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: Culturally Targeted
n=161 Participants
African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.
Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans.
|
|---|---|---|---|
|
Antibody Testing Perceived Behavioral Control
|
5.88 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.19
|
5.71 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.29
|
5.76 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.37
|
PRIMARY outcome
Timeframe: Immediately following didactic study portion and health communication randomization on day 1.Population: All participants for whom Theory of Planned Behavior measure was successfully recorded immediately following messaging randomization.
Sub-measure of Theory of Planned Behavior indicating Intentions to Complete Antibody Testing (Seven point Likert Rating, with higher scores indicating stronger screening Intentions).
Outcome measures
| Measure |
White Flint Registry: General
n=198 Participants
White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: General
n=128 Participants
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: Culturally Targeted
n=161 Participants
African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.
Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans.
|
|---|---|---|---|
|
Antibody Testing Intentions
|
4.81 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.52
|
4.61 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.54
|
4.83 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.57
|
PRIMARY outcome
Timeframe: Immediately following didactic study portion and health communication randomization on day 1.Population: All participants for whom Anticipatory Racism measure was successfully recorded immediately following messaging randomization.
Extent to which participants believe that racism-related factors would diminish the value of SARS-CoV-2 antibody testing for self (Seven-point Likert rating, with higher scores indicating greater Anticipatory Racism).
Outcome measures
| Measure |
White Flint Registry: General
n=198 Participants
White participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: General
n=128 Participants
African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
|
African American Registry: Culturally Targeted
n=161 Participants
African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.
Culturally Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans.
|
|---|---|---|---|
|
Antibody Testing Anticipatory Racism
|
1.79 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.25
|
2.93 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.54
|
2.94 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.57
|
Adverse Events
White Flint Registry: General
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
African American Registry: General
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
African American Registry: Culturally Targeted
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place