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临床试验/NCT05112900
NCT05112900已完成3 期

SCALE-UP Counts: A Health Information Technology Approach to Increasing COVID-19 Testing in Elementary and Middle Schools Serving Disadvantaged Communities

University of Utah1 个研究点 分布在 1 个国家目标入组 7,122 人开始时间: 2022年1月11日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
7,122
试验地点
1
主要终点
Testing Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by Households

研究概览

简要总结

This project will address key testing challenges in Utah schools by building on collaborations with public school districts, private schools, charter schools and with Utah Department of Health on coronavirus disease (COVID-19) testing and existing infrastructure. The study team will work closely with schools and the Utah public health system to implement and test a shovel-ready and scalable health information technology approach that delivers automated text messages (TM) to students' parents around COVID-19 testing. In addition, some parents will receive a health navigator (HN) follow-up to ensure that tests are completed. Families will be offered the recently FDA-approved in-home serial testing approach if accessing in-person testing is a challenge. While this project is focused on COVID-19 testing, in the case that the COVID-19 vaccination becomes more relevant or is the priority of the school, the study team is able to tailor the intervention to focus on the vaccine as well. The outcomes in this study utilized parent/student reported data. Staff data were also collected but will not be reflected in primary outcome analyses.

详细描述

Intervention: Randomization of parent/student participants will take place upon enrollment in the study. Participants are assigned to either usual care (UC), text messaging (TM), or text messaging plus health navigation (TM+HN).

Participants included are those who did not opt-out of the study. Participants eligible for Randomization will either be assigned to 1) Usual Care (control, approximately 20% of participants), 2) Text Message (TM, approximately 40% of participants), or 3) Text Message plus Health Navigation (TM+HN, approximately 40% of participants).

Usual Care participants will only receive unidirectional and fixed public service announcement-type text messaging on COVID-19 testing every 3 weeks (e.g., recommendation to obtain COVID-19 testing if exposed or experience symptoms; information on testing options through the school or district).

TM consists of a more intensive, bidirectional text message prompt asking if a participant has COVID-19 symptoms or if a participant has been exposed to a person that has tested positive for COVID-19, or if the participant has interest in preemptive testing. If a participant responds yes, they will receive a TM prompt for immediate testing and to re-test. Participants will be provided with information on testing options for COVID-19. After 24 hours, the participant will be asked if they tested and what their results are. After 3 days, participants will be prompted to re-test. If a participant had interest in preemptive testing, they will be asked if testing was completed after 7 days. Testing and re-testing prompts will be adjusted through the study to mirror public health guidance on testing strategies.

TM+HN consists of the same intervention as TM with the addition of health navigation services based on participant non-compliance. Participants will be evaluated as non-compliant if they had reported symptoms, contact, or interest in testing and then stop responding to text messages or respond that they did not test. Health navigator (HN) calls will be conducted using Motivation and Problem Solving (MAPS). MAPS is an empirically validated proactive coaching approach used to address barriers and motivate participants to utilize testing options if they are experiencing COVID-19 symptoms, have been exposed to someone that has tested positive for COVID-19, or reported interest in preemptive testing.

研究设计

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

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Attends school at any of the participating schools from the districts the research team is working with
  • •Legal guardian/parent of the student
  • •Has a functioning cellular phone that can receive calls and text messages

排除标准

  • 未提供

研究组 & 干预措施

Usual Care

No Intervention

Participants will only receive unidirectional public service announcement-type text messaging on COVID-19 testing every 3 weeks such as recommendation to obtain COVID-19 testing if exposed, experience symptoms, or have an interest in preemptive testing and information on testing options through the school or district.

Text Messaging (TM)

Experimental

This arm consists of a text message (TM) prompt asking if a participant has COVID-19 symptoms or if a participant has been exposed to a person who has tested positive for COVID-19. If a participant responds yes, they will receive a TM prompt for immediate testing and to re-test. Participants will also be asked if they have an interest in preemptive testing, regardless of symptoms or exposure Participants will be provided with information on testing options. After 24 hours, the participant will receive another TM that asks if they tested and what their results are. After 3 days, participants will be prompted to re-test.

干预措施: Text Messaging (TM) (Behavioral)

Text Messaging plus Health Navigation (TM+HN)

Experimental

TM+HN consists of the same intervention as TM with the addition of health navigation services based on non-compliance. Participants will be evaluated as non-compliant if they had reported symptoms, contact, or interest in testing and then stop responding to text messages or respond that they did not test. Health navigator (HN) calls will be conducted using Motivation and Problem Solving (MAPS).

干预措施: Text Messaging + Health Navigation (TM+HN) (Behavioral)

结局指标

主要结局

Testing Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by Households

时间窗: Monthly (up to 16-months post-baseline)

The study team will examine whether students and/or members of their household tested by analyzing the number of valid responses that confirmed COVID-19 testing was completed by households

次要结局

  • Missed School Days(Monthly (up to 16-months post-baseline))

研究者

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

Yelena Wu

Associate Professor, Investigator

University of Utah

研究点 (1)

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