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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD016834 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tough Talks COVID | Behavioral | Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| COVID Vaccine Uptake at Month 1 | COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination | 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 | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Hightow-Weidman, MD, MPH | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32306 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40594178 | Derived | 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. | |
| 39256711 | Derived | Budhwani 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. |
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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.
The results will be shared beginning 9 to 36 months following publication.
Requesting investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2-Arm Randomized Control Trial |
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| Standard of Care - App Access Crossover |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Month 1 |
|
Adverse event data was collected during the time participants were enrolled. Intervention participants for 3 months; Standard of Care (Control) for 3 or 6 months depending on if they received the app later on.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Hightow-Weidman, MD, MPH | Florida State University | 8506443296 | lhightowweidman@fsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2023 | Dec 11, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 7, 2023 | Dec 11, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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 | Up to 3 Months |
| 36689557 | Derived | Budhwani 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. |
| Month 6 Survey |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| State of Residence | Count of Participants | Participants |
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| OG001 | 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. |
|
|
| 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 | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | score on a scale | Up to 3 Months |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | score on a scale | Up to 3 Months |
|
|
|
| 0 |
| 180 |
| 0 |
| 180 |
| 0 |
| 180 |
| EG001 | 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. | 0 | 180 | 0 | 180 | 0 | 180 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |