Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05490329 |
Other study ID # |
21-1746 |
Secondary ID |
R01MD016834 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 13, 2023 |
Est. completion date |
December 15, 2023 |
Study information
Verified date |
January 2024 |
Source |
Florida State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.