Stepped-wedge Design Study of Point-of-care Molecular Testing for Influenza and Treatment With Baloxavir for Prevention of Secondary Transmission of Influenza in Homeless Shelters in Seattle, WA
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1,618
- 试验地点
- 9
- 主要终点
- Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period
研究概览
简要总结
This study is a stepped-wedge cluster-randomized trial of on-site rapid testing and treatment for influenza in homeless shelters within the Seattle area to determine whether this strategy reduced the incidence of influenza in the shelter environment.
详细描述
The study will be conducted over the course of two flu seasons, and all shelters will start with routine surveillance of influenza using mid-turbinate nasal swabs for sample collection and RT-PCR testing. Shelters will be randomized to implement a test-and-treat strategy at different months throughout flu season, treating individuals who present ARI symptoms or new or worsening cough within 2 days (48 hours). Shelters will continue routine surveillance until all offer the test-and-treat strategy. Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment. Individuals with 3-7 days of symptoms, or who choose not to participate in the intervention strategy, will still be eligible for participation in the routine surveillance.
Our primary hypothesis is that implementation of a point-of-care diagnostic and antiviral treatment intervention among sheltered individuals experiencing homelessness will reduce the incidence of influenza within this population over the course of a flu season. A process evaluation will also be conducted to explore the feasibility of point-of-care testing implementation in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resident for 1 or more days at a participating shelter
- •≥2 ARI symptoms or acute cough alone
- •Willing to take study medication
- •Willing to comply with all study procedures, including weekly surveillance and repeat nasal swab at day 2/3 and day 5/6/7 post-treatment
- •Able to provide written, informed consent and/or assent
排除标准
- •Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration
- •Inability to consent and/or comply with study protocol
- •Individuals who have received oseltamivir or baloxavir within past 7 days for treatment of influenza
- •Individuals with known hypersensitivity to baloxavir marboxil or oseltamivir
- •Individuals with chronic kidney disease
研究组 & 干预措施
Standard influenza surveillance
Subjects exhibiting ≥ 2 ARI symptoms or new or worsening cough in the last 7 days at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab for RT-PCR testing.
Point-of-care molecular testing and treatment of influenza
Subjects exhibiting ≥ 2 ARI symptoms, or new or worsening cough, in the last 48 hrs at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab to be tested on-site with a molecular assay (Abbott ID NOW™ Influenza A & B (Chicago, IL)) and receive an antiviral if tested positive (XOFLUZA™ or Tamiflu®) .
干预措施: Point-of-care molecular testing and treatment of influenza (Combination Product)
结局指标
主要结局
Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period
时间窗: Year 1 of the intervention (4.5 months)
The intervention period is when test and treatment on-site was available and the control period is when just standard surveillance was available at a shelter.
次要结局
- Number of Participants That Drop Out of Study(Up to 24 months)
- Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters(Up to 24 months)
- Feasibility of Implementation of Influenza Treatment in Shelters(Up to 24 months)
- Influenza Viral RNA Levels(Up to 24 months)
- Number of Participants That Show Non-compliance With Study Drug(Up to 24 months)
- Number of Laboratory-confirmed Influenza Cases That Report Fever(Up to 24 months)
- Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7(Up to 24 months)
研究者
Helen Chu
Assistant Professor, School of Medicine: Division of Allergy & Infectious Diseases
University of Washington