COVID-19NCT05490329
Addressing Vaccine Hesitancy and Increasing COVID-19 Vaccine Uptake Among African American Young Adults in the South
A study testing Tough Talks COVID in people with COVID-19 and Vaccine Uptake, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Vaccine Uptake
- What is being tested?
- Tough Talks COVID
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Identify as African American/Black
- Able to speak and read English
- Has access to personal smartphone
- Current resident of AL, GA, NC
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- COVID-19, Vaccine Uptake
- Being tested
- Tough Talks COVID
- Keywords
- Vaccine Hesitancy
- Medical subject headings
- COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tough Talks COVIDBehavioural
Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (Control) | No intervention | Research staff will provide COVID vaccine materials from the Centers for Disease Control (CDC) to those participants in the Standard of Care (SOC) arm. |
| TT-C Intervention | Experimental | 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. Receives: Behavioral: Tough Talks COVID |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID Vaccine Uptake at Month 1
COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination
Measured: Month 1
COVID Vaccine Uptake at Month 3
COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination
Measured: Month 3
Secondary outcomes (2)
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
Measured: Up to 3 Months
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
Measured: Up to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start13 Mar 2023
- Primary completion15 Dec 2023
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Lisa Hightow-Weidman, Florida State University
- Investigators
- Lisa Hightow-Weidman, MD, MPH, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490329
- Sponsor's protocol ID
- 21-1746
- Other IDs
- R01MD016834
- Status last verified
- Mar 2025
- First submitted
- 3 Aug 2022
- Last updated
- 28 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Budhwani H, Stoner MCD, Stocks JB, Browne E, Soberano Z, Bond CL, Michaels J, Mancuso N, Larsen MA, Maragh-Bass AC, Tolley EE, Comello MLG, Muessig KE, Pettifor AE, Hightow-Weidman LB. Tough talks COVID-19 (TT-C) digital health intervention: multistate randomized controlled trial. Sci Rep. 2025 Jul 1;15(1):21988. doi: 10.1038/s41598-025-05386-2.
PubMed 40594178Mancuso N, Michaels J, Browne EN, Maragh-Bass AC, Stocks JB, Soberano ZR, Bond CL, Yigit I, Comello MLG, Larsen MA, Muessig KE, Pettifor A, Hightow-Weidman LB, Budhwani H, Stoner MCD. Greater Improvements in Vaccination Outcomes Among Black Young Adults With Vaccine-Resistant Attitudes in the United States South Following a Digital Health Intervention: Latent Profile Analysis of a Randomized Control Trial. JMIR Public Health Surveill. 2025 Apr 16;11:e67370. doi: 10.2196/67370.
PubMed 40239211Budhwani H, Yigit I, Stocks JB, Stoner MCD, Browne E, Pettifor AE, Hightow-Weidman LB. Development and validation of the mpox stigma scale (MSS) and mpox knowledge scale (MKS). BMC Public Health. 2024 Sep 10;24(1):2469. doi: 10.1186/s12889-024-19868-x.
PubMed 39256711Budhwani H, Maragh-Bass AC, Tolley EE, Comello MLG, Stoner MCD, Adams Larsen M, Brambilla D, Muessig KE, Pettifor A, Bond CL, Toval C, Hightow-Weidman LB. Tough Talks COVID-19 Digital Health Intervention for Vaccine Hesitancy Among Black Young Adults: Protocol for a Hybrid Type 1 Effectiveness Implementation Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 13;12:e41240. doi: 10.2196/41240.
PubMed 36689557
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05490329
- Acronym / sponsor ID
- 21-1746
- Conditions
- COVID-19, Vaccine Uptake
- Keywords
- Vaccine Hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Posted 28 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Control) | No intervention | –Research staff will provide COVID vaccine materials from the Centers for Disease Control (CDC) to those participants in the Standard of Care (SOC) arm. |
| TT-C Intervention | Experimental | Behavioral: Tough Talks COVIDResearch 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Identify as African American/Black
- Able to speak and read English
- Has access to personal smartphone
- Current resident of AL, GA, NC
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tough Talks COVIDIntervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month. | Behavioural | TT-C Intervention |
Primary outcome
COVID Vaccine Uptake at Month 1
Time frame: Month 1
COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination
COVID Vaccine Uptake at Month 3
Time frame: Month 3
COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination
2 secondary outcomes
COVID Vaccine Confidence
Time frame: Up to 3 Months
COVID Vaccine Hesitancy
Time frame: Up to 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40594178Budhwani H, Stoner MCD, Stocks JB, Browne E, Soberano Z, Bond CL, Michaels J, Mancuso N, Larsen MA, Maragh-Bass AC, Tolley EE, Comello MLG, Muessig KE, Pettifor AE, Hightow-Weidman LB. Tough talks COVID-19 (TT-C) digital health intervention: multistate randomized controlled trial. Sci Rep. 2025 Jul 1;15(1):21988. doi: 10.1038/s41598-025-05386-2.
- Derived from this study: PubMed 40239211Mancuso N, Michaels J, Browne EN, Maragh-Bass AC, Stocks JB, Soberano ZR, Bond CL, Yigit I, Comello MLG, Larsen MA, Muessig KE, Pettifor A, Hightow-Weidman LB, Budhwani H, Stoner MCD. Greater Improvements in Vaccination Outcomes Among Black Young Adults With Vaccine-Resistant Attitudes in the United States South Following a Digital Health Intervention: Latent Profile Analysis of a Randomized Control Trial. JMIR Public Health Surveill. 2025 Apr 16;11:e67370. doi: 10.2196/67370.
- Derived from this study: PubMed 39256711Budhwani H, Yigit I, Stocks JB, Stoner MCD, Browne E, Pettifor AE, Hightow-Weidman LB. Development and validation of the mpox stigma scale (MSS) and mpox knowledge scale (MKS). BMC Public Health. 2024 Sep 10;24(1):2469. doi: 10.1186/s12889-024-19868-x.
- Derived from this study: PubMed 36689557Budhwani H, Maragh-Bass AC, Tolley EE, Comello MLG, Stoner MCD, Adams Larsen M, Brambilla D, Muessig KE, Pettifor A, Bond CL, Toval C, Hightow-Weidman LB. Tough Talks COVID-19 Digital Health Intervention for Vaccine Hesitancy Among Black Young Adults: Protocol for a Hybrid Type 1 Effectiveness Implementation Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 13;12:e41240. doi: 10.2196/41240.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Hightow-Weidman, MD, MPH principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tough Talks COVID in people with COVID-19 and Vaccine Uptake, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID Vaccine Uptake at Month 1 (time frame: Month 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05490329, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.