Addressing Vaccine Hesitancy and Increasing COVID-19 Vaccine Uptake Among African American Young Adults in the South
Condition: COVID-19; Vaccine Uptake
MeSH terms: COVID-19
Study type: Interventional

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.
    

Intervention name(s): Tough Talks COVID
Intervention type(s): Behavioral
Intervention description(s): Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine Hesitancy