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临床试验/NCT07074171
NCT07074171已完成不适用

Addressing COVID-19 Testing Disparities in Vulnerable Populations Using a Community JITAI (Just in Time Adaptive Intervention) Approach: RADx-Underserved Populations (RADxUP) Phase III

The University of Texas Health Science Center, Houston3 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2023年4月3日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
384
试验地点
3
主要终点
Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test

研究概览

简要总结

In this Phase III study, the investigators will build off of the Phase II embedded study with some adjustments to the design to address new research priorities that examine an intervention that is network informed and delivered through community health worker interactions plus digitally-delivered intervention content with the goal of increasing COVID-19 testing and vaccination. This model, if proven effective, can be scaled up to address COVID-19 and other future pandemics. The investigators will utilize the sample of intervention priority census block groups (PBGs) used in Phase II and will recruit and enroll participants not previously enrolled in either phase I or II from these PBGs using convenience sampling methods. The investigators will use a historical control group consisting of participants from our control arm in Phase II who completed both their baseline and follow-up surveys embedded in the study.

详细描述

The Phase III study design focuses on vulnerable communities selected to intervention and control conditions and takes advantage of the fact that these communities were randomized to conditions using methods to ensure balanced arms. In Phase III, the investigators will combine the two intervention conditions [Testing Navigation Intervention (TNI) and Facilitated Self-Sampling Intervention (FSSI), and will receive the Multilevel Community network-informed Just-In-Time-Adaptive Intervention (MC-NET-JITAI). The study will include PBGs from each of the two intervention conditions in Phase II; they will be matched to the comparison PBGs on variables such as size, vaccination and testing rates, and the disparities index with the control group. The intervention will last 8 weeks; individuals will be recruited and asked to complete a survey.

Participants who live in a PBG randomized to the intervention arm will be invited to participate in the trial for that arm. In each of the selected intervention PBGs, individuals will be selected via convenience sampling procedures. Recruitment of participants to the MC-NET-JITAI will take place at the participant's home or at one of the community organizations that our participants look to and interact with around COVID-19 topics identified through the social network data. Community Health Workers (CHW) will consent and enroll participants in the MC-NET-JITAI from the randomized PBGs. MC-NET-JITAI will include CHWs providing the participant with a batch of 4 rapid antigen tests that can be shared with people in the household or other close contacts if needed, a COVID-19 resource flier tailored to the study region and updated information about COVID-19 testing and vaccination. The intervention will consist of enhanced behavioral and educational text messages, up to three messages each week, providing updates on COVID-19 testing and vaccination. The text messages will include digitally delivered intervention content such as a video with low-literacy instructions for administering the rapid antigen tests, guidance if they tested positive (e.g., quarantine, notify contacts, wearing a mask), and other relevant strategies and content focused on increasing COVID-19 testing and vaccination. The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow up via text, email and/or phone with the participants during the two months post-enrollment. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online, over the phone, or in person two months after the initial intervention. Study data will be compared to historical control data from the previous phase II Embedded Study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • having a smartphone that accepts text messages

排除标准

  • having been diagnosed with COVID-19 in the past 30 days based on a positive test (antigen or PCR) or a clinical diagnosis
  • having tested for COVID-19 with PCR or antigen test within the past 30 days
  • not being available in the recruitment area in the next 60 days
  • having been an embedded study participant
  • having been a snowball study participant.

研究组 & 干预措施

Text message-based education intervention

Experimental

A text message-based COVID-19 education intervention with support from community health workers.

干预措施: Text message-based education intervention (Behavioral)

Historical Control Group

Other

Participants in this Historical Control Group completed the prior Phase II embedded study, in which they received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys only.

干预措施: Historical Control (Other)

结局指标

主要结局

Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test

时间窗: 8 weeks

The number of participants who self-reported use of COVID-19 antigen test or PCR Test using individual-level data in the past 60 days

Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test

时间窗: Baseline

The number of participants who self-reported use of COVID-19 antigen test or PCR Test using individual-level data in the past 60 days

次要结局

  • Number of Participants Who Self-reported Receiving COVID-19 Vaccination(8 weeks)
  • Number of Participants Who Self-reported Used Mitigation Measures if a Positive Test is Obtained(Baseline, 8 weeks)
  • Number of Participants Who Self-reported Receiving COVID-19 Vaccination(Baseline)

研究者

发起方
The University of Texas Health Science Center, Houston
申办方类型
Other
责任方
Principal Investigator
主要研究者

Belinda Reininger

Professor and Regional Campus Dean in Brownsville

The University of Texas Health Science Center, Houston

研究点 (3)

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