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Addressing Vaccine Hesitancy and Increasing COVID-19 Vaccine Uptake Among African American Young Adults in the South

A Multidimensional Digital Approach to Address Vaccine Hesitancy and Increase COVID-19 Vaccine Uptake Among African American Young Adults in the South (Tough Talks COVID)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05490329
Enrollment
360
Registered
2022-08-05
Start date
2023-03-13
Completion date
2024-06-15
Last updated
2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Vaccine Uptake

Keywords

Vaccine Hesitancy

Brief summary

The study staff will conduct a hybrid type 1 effectiveness implementation 2-arm trail with 360 Black young adults from Alabama, Georgia, and North Carolina. Participants will be randomized to receive the standard of care (control) or the TT-C intervention arm, each with a balance of 180 participants. Primary effectiveness outcome is COVID-19 vaccine uptake define as receipt of any vaccine (primary series or secondary booster). Secondary effectiveness outcomes are vaccine hesitancy, confidence, and knowledge, attitudes, and beliefs. The study staff will also conduct qualitative interviews with a group of purposively selected AA-YA participants (est. n=12-16) and site staff (est. n=6-8) to assess barriers and facilitators to implementation. The hypothesis is that the intervention arm will be more effective than the control arm at increasing vaccine uptake.

Detailed description

The study staff will recruit and enroll 360 AA-YA from communities in Alabama, Georgia, and North Carolina. After collecting informed consent, participants will be randomized using block randomization to the control condition or TT-C (remote), each with a balanced 180 participants (N=360). The standard of care (SOC) control will be the provision of COVID vaccine materials from the CDC. After screening eligible and agreeing to be contacted, eligible responses will be reviewed individually by study staff to determine authenticity and legitimacy. In addition to eligibility criteria, staff will review bot detection values as well as location based on IP address & latitude/longitude. If determined eligible, staff complete the Verification CRF and REDCap emails the individual with a unique consent form link to complete. Once completed, REDCap sends the baseline survey linked to their unique ID in REDCap. After the baseline survey is complete, study staff will randomize the participant with the Randomization CRF to either the intervention or control group. Based on the study arm, study staff will either email the participant with the developed SOC materials or email the participant with a unique link to create their account for the TT-C app. If SOC, study staff will compensate the participant $50 for enrolling. If participant is randomized to intervention arm, they will be prompted to create their account with the provided link, then will be directed to download and login to the TT-C app. Once account creation is confirmed in the administrator portal, study staff will compensate the participant $50 for enrolling. TT-C arm: Once enrolled, participants will be emailed a unique link to create their TT-C account and instructions on how to download the TT-C (remote) app from the iOS or Google Play store. They will be asked to complete the intervention within one month. Participants will be compensated $50 for completing the baseline and reminded that they will be asked to return in 1 and 3 months for follow-up. SOC arm: Research staff will provide COVID vaccine materials from the CDC to those participants in the SOC arm. Participants will be compensated $50 for completing the baseline and reminded that they will be asked to complete 1 and 3-month follow- up surveys. 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 VH will be offered the opportunity to accept the TT-C intervention delivered remotely.

Interventions

BEHAVIORALTough Talks COVID

Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month.

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Florida State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes

Inclusion criteria

* Identify as African American/Black * Able to speak and read English * Has access to personal smartphone * Current resident of AL, GA, NC

Exclusion criteria

* Aged younger than 18 year or older than 29 years * Does not identify as African American/Black * Non-English speaking * Does not live in Al, GA, NC * Unable to provide informed consent * Receipt of full COVID vaccine series (including vaccination and booster or prior participation in a vaccine trial)

Design outcomes

Primary

MeasureTime frameDescription
COVID Vaccine Uptake at Month 3Month 3COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination
COVID Vaccine Uptake at Month 1Month 1COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination

Secondary

MeasureTime frameDescription
COVID Vaccine ConfidenceUp 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
COVID Vaccine HesitancyUp 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

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
180
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.
180
Total360

Withdrawals & dropouts

PeriodReasonFG000FG001
2-Arm Randomized Control TrialLost to Follow-up825
2-Arm Randomized Control TrialWithdrawal by Subject01
Standard of Care - App Access CrossoverLost to Follow-up90

Baseline characteristics

CharacteristicStandard of Care (Control)TT-C InterventionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
180 Participants180 Participants360 Participants
Age, Continuous23.8 years
STANDARD_DEVIATION 3.4
23.7 years
STANDARD_DEVIATION 3.5
23.7 years
STANDARD_DEVIATION 3.4
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants8 Participants16 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
172 Participants172 Participants344 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
180 Participants180 Participants360 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
180 participants180 participants360 participants
Sex: Female, Male
Female
149 Participants150 Participants299 Participants
Sex: Female, Male
Male
31 Participants30 Participants61 Participants
State of Residence
Alabama
34 Participants33 Participants67 Participants
State of Residence
Georgia
80 Participants80 Participants160 Participants
State of Residence
North Carolina
66 Participants67 Participants133 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1800 / 180
other
Total, other adverse events
0 / 1800 / 180
serious
Total, serious adverse events
0 / 1800 / 180

Outcome results

Primary

COVID Vaccine Uptake at Month 1

COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination

Time frame: Month 1

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard of Care (Control)COVID Vaccine Uptake at Month 16 Participants
TT-C InterventionCOVID Vaccine Uptake at Month 15 Participants
Primary

COVID Vaccine Uptake at Month 3

COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination

Time frame: Month 3

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard of Care (Control)COVID Vaccine Uptake at Month 38 Participants
TT-C InterventionCOVID Vaccine Uptake at Month 313 Participants
Secondary

COVID Vaccine Confidence

COVID 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

Time frame: Up to 3 Months

ArmMeasureValue (MEDIAN)
Standard of Care (Control)COVID Vaccine Confidence3.57 score on a scale
TT-C InterventionCOVID Vaccine Confidence3.71 score on a scale
Secondary

COVID Vaccine Hesitancy

COVID 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

Time frame: Up to 3 Months

ArmMeasureValue (MEDIAN)
Standard of Care (Control)COVID Vaccine Hesitancy2.22 score on a scale
TT-C InterventionCOVID Vaccine Hesitancy2.00 score on a scale

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026