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临床试验/NCT05490329
NCT05490329已完成不适用

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)

Florida State University2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2023年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
360
试验地点
2
主要终点
COVID Vaccine Uptake at Month 1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

结局指标

主要结局

COVID Vaccine Uptake at Month 1

时间窗: 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

时间窗: Month 3

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

次要结局

  • COVID Vaccine Confidence(Up to 3 Months)
  • COVID Vaccine Hesitancy(Up to 3 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa Hightow-Weidman

Principal Investigator

Florida State University

研究点 (2)

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