Trial Outcomes & Findings for Rural Tailored COVID-19 Communication to Promote SARS-CoV-2 Antibody Testing in Saliva (NCT NCT06085547)
NCT ID: NCT06085547
Last Updated: 2025-01-17
Results Overview
Number (percentage) of participants who respond "yes" to be included in the offer to participate in no cost home-based SARS-CoV-2 salivary antibody testing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
264 participants
Primary outcome timeframe
Immediately following didactic study portion and health communication randomization on day 1.
Results posted on
2025-01-17
Participant Flow
Of 264 enrolled participants, 207 met inclusion criteria and were randomized to a video group. Of the 207 participants who participated in the survey, 13 participants were filtered out for inattentiveness.
Participant milestones
| Measure |
White Rural: General
White rural 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 rural-targeted information
|
White Rural: Rural-Targeted
White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing.
Rural-Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a two and a half minute video based messaging adjunct meant to enact a rural-targeted framing of health information presented to White rural individuals.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
94
|
|
Overall Study
COMPLETED
|
100
|
94
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rural Tailored COVID-19 Communication to Promote SARS-CoV-2 Antibody Testing in Saliva
Baseline characteristics by cohort
| Measure |
White Rural: General
n=100 Participants
White rural 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 rural-targeted information
|
White Rural: Rural-Targeted
n=94 Participants
White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing.
Rural-Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a two and a half minute video based messaging adjunct meant to enact a rural-targeted framing of health information presented to White rural individuals.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-21 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
22-40 years
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Customized
>= 41
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately following didactic study portion and health communication randomization on day 1.Number (percentage) of participants who respond "yes" to be included in the offer to participate in no cost home-based SARS-CoV-2 salivary antibody testing.
Outcome measures
| Measure |
White Rural: General
n=100 Participants
White rural 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 rural-targeted information
|
White Rural: Rural-Targeted
n=94 Participants
White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing.
Rural-Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a two and a half minute video based messaging adjunct meant to enact a rural-targeted framing of health information presented to White rural individuals.
|
|---|---|---|
|
Number (Percentage) of Participants Requested to Participate in Home-based Saliva-based SARS-CoV-2 Antibody Testing.
|
91 Participants
|
88 Participants
|
PRIMARY outcome
Timeframe: 8 weeks from the day of consenting to participate in the home-based salivary-based SARS-CoV-2 antibody testing.Number (Percentage) of participants that requested to participate in antibody testing who actually complete antibody testing.
Outcome measures
| Measure |
White Rural: General
n=91 Participants
White rural 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 rural-targeted information
|
White Rural: Rural-Targeted
n=88 Participants
White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing.
Rural-Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a two and a half minute video based messaging adjunct meant to enact a rural-targeted framing of health information presented to White rural individuals.
|
|---|---|---|
|
Number (Percentage) of Participants Who Completed Home-based Salivary Antibody Testing.
|
77 Participants
|
70 Participants
|
PRIMARY outcome
Timeframe: collected immediately, up to 1 hourSelf-report measures of antibody testing attitudes, norms, perceived control, and intentions to be screened are each adapted from published research (Lucas et al., 2021). These items are constructed following recommended procedures to ensure construct validity and adequate behavioral specificity (Fishbein \& Ajzen, 2011). All items use Likert-type scales that range from 1 (Strongly Agree) to 7 (Strongly Disagree).
Outcome measures
| Measure |
White Rural: General
n=100 Participants
White rural 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 rural-targeted information
|
White Rural: Rural-Targeted
n=94 Participants
White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing.
Rural-Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a two and a half minute video based messaging adjunct meant to enact a rural-targeted framing of health information presented to White rural individuals.
|
|---|---|---|
|
Theory of Planned Behavior Antibody Testing Outcomes
SARS-CoV-2 Antibody Testing Attitudes
|
5.97 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation .966
|
5.97 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation .910
|
|
Theory of Planned Behavior Antibody Testing Outcomes
SARS-CoV-2 Antibody Testing Normative Beliefs
|
4.01 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.244
|
3.85 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.158
|
|
Theory of Planned Behavior Antibody Testing Outcomes
Antibody Testing Perceived Behavioral Control
|
6.06 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.026
|
6.02 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.092
|
|
Theory of Planned Behavior Antibody Testing Outcomes
Antibody Testing Intentions
|
4.80 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.487
|
4.92 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.455
|
PRIMARY outcome
Timeframe: Immediately following didactic study portion and health communication randomization on day 1.Population: All participants for whom Rural-adapted Anticipatory Racism measure was successfully recorded immediately following messaging randomization.
Extent to which participants believe that rural 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 Rural: General
n=100 Participants
White rural 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 rural-targeted information
|
White Rural: Rural-Targeted
n=94 Participants
White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing.
Rural-Targeted SARS-CoV-2 Communication: SARS-CoV-2 video tutorial includes a two and a half minute video based messaging adjunct meant to enact a rural-targeted framing of health information presented to White rural individuals.
|
|---|---|---|
|
Antibody Testing Rural-Adapted Anticipatory Racism
|
1.63 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation .885
|
2.18 Units on a Scale (Minimum:1, Maximum:7)
Standard Deviation 1.166
|
Adverse Events
White Rural: General
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
White Rural: Rural-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