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临床试验/NCT05606016
NCT05606016已完成不适用

Examining How a Facilitated Self-Sampling Intervention and Testing Navigation Intervention Influences COVID-19 Testing in Vulnerable Populations

The University of Texas Health Science Center, Houston6 个研究点 分布在 1 个国家目标入组 1,232 人开始时间: 2023年3月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,232
试验地点
6
主要终点
Number of Participants Who Complete Testing (Antigen or PCR)

研究概览

简要总结

Antigen self-testing kits are more available at this stage in the pandemic, but among vulnerable populations, use is still low and instructions for antigen testing are not typically designed for low health literacy populations. Studies are needed to explore access and use of antigen tests among vulnerable populations and examine if low-health-literacy-designed interventions improve COVID-19 testing decisions and behaviors. This study will focus on understanding factors associated with rapid COVID-19 testing, specifically. The primary objectives of the embedded study are to 1) Determine the effectiveness of community-level intervention using door-to-door recruitment and education in increasing COVID-19 testing and 2) Compare the effectiveness of the CHW- Facilitated Self-Sampling Intervention (FSSI) vs. CHW Testing Navigation Intervention (TNI).

详细描述

The pandemic landscape and people's experiences with testing, infection, and vaccination have changed dramatically over the past two years. Vaccines have become available, testing access in local communities has waxed and waned, and attitudes toward COVID-19 severity and susceptibility have shifted. Navigating the testing-decision landscape is confusing to the public (test availability for free versus charged or requiring insurance; testing and vaccination locations change; PCR versus antigen testing; home tests versus clinically delivered; symptom-based testing, exposure-driven testing, serial testing, resources to trust or not trust, etc.).

This study, referred to as the embedded study, builds off a broader population-based group randomized controlled trial (RCT) to evaluate the effects of a Facilitated Self-Sampling Intervention and Testing Navigation Intervention on testing behaviors. The embedded study will randomly select and assign priority block groups from the RCT to one of three arms - FSSI (n=16), TNI (n=16), or Control (n= 32). The allocation will be at a 2:1:1 rate across the three regions Houston/Harris County, South Texas, and Northeast Texas respectively. Community Health Workers will systematically sample and recruit 20 individuals from each PBG using a random start procedure. Study participants in the intervention arms will be enrolled, complete a baseline survey, receive a brief educational intervention, and complete a follow-up survey. Participants in the control arm will complete a baseline and follow-up survey.

研究设计

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

入排标准

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

入选标准

  • •Aged 18 years or older

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

研究组 & 干预措施

Facilitated Self-Sampling Intervention (FSSI)

Experimental

Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.

干预措施: Facilitated Self-Sampling Intervention (FSSI) (Behavioral)

Testing Navigation Intervention (TNI).

Experimental

Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.

干预措施: Testing Navigation Intervention (TNI). (Behavioral)

Control

Active Comparator

Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.

干预措施: Control (Behavioral)

结局指标

主要结局

Number of Participants Who Complete Testing (Antigen or PCR)

时间窗: between baseline and 2 months after the intervention

Percent of participants from each study arm who complete testing (antigen or PCR)

次要结局

  • Number of Participants Who Appropriately Used Antigen Test as Assessed by Survey(baseline)
  • Number of Participants Who Appropriately Used Antigen Test as Assessed by Survey(2 months after the intervention)
  • Number of Participants With a Positive Test Who Took Mitigation Measures as Assessed by Survey(baseline)
  • Number of Participants With a Positive Test Who Took Mitigation Measures as Assessed by Survey(2 months after the intervention)
  • Number of Participants Who Share Antigen Tests With Close Contacts Who Need to Test as Assessed by Survey(baseline)
  • Number of Participants Who Share Antigen Tests With Close Contacts Who Need to Test as Assessed by Survey(2 months after the intervention)
  • Number of Participants Who Tested Positive for COVID-19 in the Past 30 Days(baseline)
  • Number of Participants Vaccinated Against COVID-19(Baseline)
  • Percentage of Community Members Reported to Have Tested Positive for COVID-19(Baseline)
  • Percentage of Community Members Reported to Be Vaccinated Against COVID-19(Baseline)
  • Number of Participants Reporting Trust in National Government Regarding COVID-19 Information(Baseline)

研究者

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

Maria E Fernandez

Lorne Bain Distinguished Professorship in Public Health and Director, Center for Health Promotion and Prevention Research

The University of Texas Health Science Center, Houston

研究点 (6)

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