Test-and-treat for Influenza in Homeless Shelters

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04141917
• Other study ID #: STUDY00007800
• Status: Terminated
• Phase: Phase 4
• Start date: November 15, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: May 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1618
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Respiratory Viral Infection
• Virus Diseases

Intervention

Combination Product:
• Point-of-care molecular testing and treatment of influenza
Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged =12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving.

Locations

Country	Name	City	State
United States	Mary's Place Burien	Burien	Washington
United States	Compass Housing Alliance at First Presbyterian	Seattle	Washington
United States	Compass Housing Alliance Blaine Center Men's Shelter	Seattle	Washington
United States	Compass Housing Alliance Jan & Peter's Place Women's Shelter	Seattle	Washington
United States	Downtown Emergency Service Center Shelter	Seattle	Washington
United States	Mary's Place North Seattle	Seattle	Washington
United States	Mary's Place White Center	Seattle	Washington
United States	ROOTS Young Adult Shelter	Seattle	Washington
United States	St Martin De Porres Shelter	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Boonyaratanakornkit J, Ekici S, Magaret A, Gustafson K, Scott E, Haglund M, Kuypers J, Pergamit R, Lynch J, Chu HY. Respiratory Syncytial Virus Infection in Homeless Populations, Washington, USA. Emerg Infect Dis. 2019 Jul;25(7):1408-1411. doi: 10.3201/eid2507.181261. — View Citation

Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018 Sep 6;379(10):913-923. doi: 10.1056/NEJMoa1716197. — View Citation

Hwang SW, Orav EJ, O'Connell JJ, Lebow JM, Brennan TA. Causes of death in homeless adults in Boston. Ann Intern Med. 1997 Apr 15;126(8):625-8. — View Citation

Thiberville SD, Salez N, Benkouiten S, Badiaga S, Charrel R, Brouqui P. Respiratory viruses within homeless shelters in Marseille, France. BMC Res Notes. 2014 Feb 5;7:81. doi: 10.1186/1756-0500-7-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period	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.	Year 1 of the intervention (4.5 months)
Secondary	Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters	Number of participants/participant encounters with les than 48 hours between symptom onset until diagnosis with RT-PCR.	Up to 24 months
Secondary	Feasibility of Implementation of Influenza Treatment in Shelters	Number of influenza-positive participants identified through on-site molecular testing in the intervention period that were treated with an antiviral	Up to 24 months
Secondary	Number of Participants That Drop Out of Study	Measured as becoming lost to follow-up (did not complete both follow-up study visits on day 2/3 and day 5/6/7) after testing positive for influenza at baseline enrollment with an on-site molecular test and receiving an antiviral	Up to 24 months
Secondary	Number of Participants That Show Non-compliance With Study Drug	Only applicable to those that receive oseltamivir rather than baloxavir which is a single-dose antiviral. Measured based on self-report during follow-up visits with study research assistants. Non-compliance is measured as the participant self-reporting fewer doses taken than to be expected at time of of follow-up (e.g. a participant that took there first dose of oseltamivir in the AM on March 8 would be expected to have taken 6 doses if their follow-up visit was in the PM on March 10).	Up to 24 months
Secondary	Number of Laboratory-confirmed Influenza Cases That Report Fever	Based on self-report of new or worsening fever in the past 7 days; not gold standard measurement	Up to 24 months
Secondary	Influenza Viral RNA Levels	Measured mean cycle threshold (Ct) value for each laboratory-confirmed influenza-positive specimen collected at baseline enrollment, by subtype. Ct values have an inverse relationship with viral load.	Up to 24 months
Secondary	Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7	Measured at subject follow-up visits with nasal swabs provided to study staff; provided subject has not become lost to follow up.	Up to 24 months