Trial Outcomes & Findings for Addressing Vaccine Hesitancy and Increasing COVID-19 Vaccine Uptake Among African American Young Adults in the South (NCT NCT05490329)
NCT ID: NCT05490329
Last Updated: 2025-03-28
Results Overview
COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
360 participants
Primary outcome timeframe
Month 1
Results posted on
2025-03-28
Participant Flow
Participant milestones
| Measure |
Standard of Care (Control)
Research staff will provide COVID vaccine materials from the Centers for Disease Control (CDC) to those participants in the Standard of Care (SOC) arm.
To provide the maximum benefit through this trial, after the completion of the data collection associated with the primary RCT, those randomized to the control arm who still report vaccine hesitancy will be offered the opportunity to accept the TT-C intervention delivered remotely. These participants will be asked to use the app for one month and complete follow-up surveys at their 4- and 6-month time points (same surveys used for 1 and 3M). These participants will be compensated for survey completion.
|
TT-C Intervention
Research staff will provide access to the TT-COVID app for one-month, which will provide knowledge about the COVID-19 vaccine, address mis-information, and include multi-media digital stories from study participant's peers.
Tough Talks COVID: Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month.
|
|---|---|---|
|
2-Arm Randomized Control Trial
STARTED
|
180
|
180
|
|
2-Arm Randomized Control Trial
Month 1 Survey
|
174
|
159
|
|
2-Arm Randomized Control Trial
Month 3 Survey
|
172
|
154
|
|
2-Arm Randomized Control Trial
COMPLETED
|
172
|
154
|
|
2-Arm Randomized Control Trial
NOT COMPLETED
|
8
|
26
|
|
Standard of Care - App Access Crossover
STARTED
|
129
|
0
|
|
Standard of Care - App Access Crossover
Month 4 Survey
|
124
|
0
|
|
Standard of Care - App Access Crossover
Month 6 Survey
|
120
|
0
|
|
Standard of Care - App Access Crossover
COMPLETED
|
120
|
0
|
|
Standard of Care - App Access Crossover
NOT COMPLETED
|
9
|
0
|
Reasons for withdrawal
| Measure |
Standard of Care (Control)
Research staff will provide COVID vaccine materials from the Centers for Disease Control (CDC) to those participants in the Standard of Care (SOC) arm.
To provide the maximum benefit through this trial, after the completion of the data collection associated with the primary RCT, those randomized to the control arm who still report vaccine hesitancy will be offered the opportunity to accept the TT-C intervention delivered remotely. These participants will be asked to use the app for one month and complete follow-up surveys at their 4- and 6-month time points (same surveys used for 1 and 3M). These participants will be compensated for survey completion.
|
TT-C Intervention
Research staff will provide access to the TT-COVID app for one-month, which will provide knowledge about the COVID-19 vaccine, address mis-information, and include multi-media digital stories from study participant's peers.
Tough Talks COVID: Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month.
|
|---|---|---|
|
2-Arm Randomized Control Trial
Lost to Follow-up
|
8
|
25
|
|
2-Arm Randomized Control Trial
Withdrawal by Subject
|
0
|
1
|
|
Standard of Care - App Access Crossover
Lost to Follow-up
|
9
|
0
|
Baseline Characteristics
Addressing Vaccine Hesitancy and Increasing COVID-19 Vaccine Uptake Among African American Young Adults in the South
Baseline characteristics by cohort
| Measure |
Standard of Care (Control)
n=180 Participants
Research staff will provide COVID vaccine materials from the Centers for Disease Control (CDC) to those participants in the Standard of Care (SOC) arm.
To provide the maximum benefit through this trial, after the completion of the data collection associated with the primary RCT, those randomized to the control arm who still report vaccine hesitancy will be offered the opportunity to accept the TT-C intervention delivered remotely. These participants will be asked to use the app for one month and complete follow-up surveys at their 4- and 6-month time points (same surveys used for 1 and 3M). These participants will be compensated for survey completion.
|
TT-C Intervention
n=180 Participants
Research staff will provide access to the TT-COVID app for one-month, which will provide knowledge about the COVID-19 vaccine, address mis-information, and include multi-media digital stories from study participant's peers.
Tough Talks COVID: Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month.
|
Total
n=360 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
|
|
Age, Categorical
Between 18 and 65 years
|
180 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23.8 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
23.7 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
23.7 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
299 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
172 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
344 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
|
180 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
United States
|
180 participants
n=5 Participants
|
180 participants
n=7 Participants
|
360 participants
n=5 Participants
|
|
State of Residence
Alabama
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
State of Residence
Georgia
|
80 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
State of Residence
North Carolina
|
66 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 1COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination
Outcome measures
| Measure |
Standard of Care (Control)
n=175 Participants
Research staff will provide COVID vaccine materials from the Centers for Disease Control (CDC) to those participants in the Standard of Care (SOC) arm.
To provide the maximum benefit through this trial, after the completion of the data collection associated with the primary RCT, those randomized to the control arm who still report vaccine hesitancy will be offered the opportunity to accept the TT-C intervention delivered remotely. These participants will be asked to use the app for one month and complete follow-up surveys at their 4- and 6-month time points (same surveys used for 1 and 3M). These participants will be compensated for survey completion.
|
TT-C Intervention
n=164 Participants
Research staff will provide access to the TT-COVID app for one-month, which will provide knowledge about the COVID-19 vaccine, address mis-information, and include multi-media digital stories from study participant's peers.
Tough Talks COVID: Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month.
|
|---|---|---|
|
COVID Vaccine Uptake at Month 1
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Month 3COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination
Outcome measures
| Measure |
Standard of Care (Control)
n=172 Participants
Research staff will provide COVID vaccine materials from the Centers for Disease Control (CDC) to those participants in the Standard of Care (SOC) arm.
To provide the maximum benefit through this trial, after the completion of the data collection associated with the primary RCT, those randomized to the control arm who still report vaccine hesitancy will be offered the opportunity to accept the TT-C intervention delivered remotely. These participants will be asked to use the app for one month and complete follow-up surveys at their 4- and 6-month time points (same surveys used for 1 and 3M). These participants will be compensated for survey completion.
|
TT-C Intervention
n=154 Participants
Research staff will provide access to the TT-COVID app for one-month, which will provide knowledge about the COVID-19 vaccine, address mis-information, and include multi-media digital stories from study participant's peers.
Tough Talks COVID: Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month.
|
|---|---|---|
|
COVID Vaccine Uptake at Month 3
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 3 MonthsCOVID Vaccine Confidence is measured by self-reported ability to receive any primary series of booster vaccination at 1 and 3-month follow-up Vaccine confidence was a mean score of 7 items with response options ranging from 1-5, and higher scores indicating greater confidence (5=Strongly Agree). Example items were "vaccines are safe" and "vaccines do a good job in preventing the diseases they are intended to prevent." Gilkey MB, Reiter PL, Magnus BE, McRee A-L, Dempsey AF, Brewer NT. Validation of the Vaccination Confidence Scale: A Brief Measure to Identify Parents at Risk for Refusing Adolescent Vaccines. Academic Pediatrics. 2016/01/01/ 2016;16(1):42-49. doi:https://doi.org/10.1016/j.acap.2015.06.007
Outcome measures
| Measure |
Standard of Care (Control)
n=172 Participants
Research staff will provide COVID vaccine materials from the Centers for Disease Control (CDC) to those participants in the Standard of Care (SOC) arm.
To provide the maximum benefit through this trial, after the completion of the data collection associated with the primary RCT, those randomized to the control arm who still report vaccine hesitancy will be offered the opportunity to accept the TT-C intervention delivered remotely. These participants will be asked to use the app for one month and complete follow-up surveys at their 4- and 6-month time points (same surveys used for 1 and 3M). These participants will be compensated for survey completion.
|
TT-C Intervention
n=152 Participants
Research staff will provide access to the TT-COVID app for one-month, which will provide knowledge about the COVID-19 vaccine, address mis-information, and include multi-media digital stories from study participant's peers.
Tough Talks COVID: Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month.
|
|---|---|---|
|
COVID Vaccine Confidence
|
3.57 score on a scale
Interval 3.07 to 4.21
|
3.71 score on a scale
Interval 3.36 to 4.29
|
SECONDARY outcome
Timeframe: Up to 3 MonthsCOVID Vaccine Hesitancy is measured by self-reported refusal to receive any primary series or booster vaccination at 1 and 3-month follow-up Vaccine hesitancy was a mean score of a 9-item scale with response ranging from 1-5, and higher scores indicating greater hesitancy (5=Strongly Disagree). Example items included "vaccines are important for my health" and "vaccines are effective." Shapiro GK, Tatar O, Dube E, et al. The vaccine hesitancy scale: Psychometric properties and validation. Vaccine. 2018/01/29/ 2018;36(5):660-667. doi:https://doi.org/10.1016/j.vaccine.2017.12.043
Outcome measures
| Measure |
Standard of Care (Control)
n=169 Participants
Research staff will provide COVID vaccine materials from the Centers for Disease Control (CDC) to those participants in the Standard of Care (SOC) arm.
To provide the maximum benefit through this trial, after the completion of the data collection associated with the primary RCT, those randomized to the control arm who still report vaccine hesitancy will be offered the opportunity to accept the TT-C intervention delivered remotely. These participants will be asked to use the app for one month and complete follow-up surveys at their 4- and 6-month time points (same surveys used for 1 and 3M). These participants will be compensated for survey completion.
|
TT-C Intervention
n=150 Participants
Research staff will provide access to the TT-COVID app for one-month, which will provide knowledge about the COVID-19 vaccine, address mis-information, and include multi-media digital stories from study participant's peers.
Tough Talks COVID: Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month.
|
|---|---|---|
|
COVID Vaccine Hesitancy
|
2.22 score on a scale
Interval 1.78 to 2.67
|
2.00 score on a scale
Interval 1.56 to 2.56
|
Adverse Events
Standard of Care (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TT-C Intervention
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