Test-and-treat for Influenza in Homeless Shelters
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| ClinicalTrials.gov Identifier: NCT04141917 |
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Recruitment Status :
Terminated
(Operational futility (i.e. near zero circulation of influenza in the community during year 2))
First Posted : October 28, 2019
Results First Posted : June 22, 2022
Last Update Posted : June 22, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Influenza Respiratory Viral Infection | Combination Product: Point-of-care molecular testing and treatment of influenza | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1618 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | November 15, 2019 |
| Actual Primary Completion Date : | March 31, 2021 |
| Actual Study Completion Date : | March 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: 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.
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Active Comparator: 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®) .
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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. |
- Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period [ Time Frame: 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.
- Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters [ Time Frame: Up to 24 months ]Number of participants/participant encounters with les than 48 hours between symptom onset until diagnosis with RT-PCR.
- Feasibility of Implementation of Influenza Treatment in Shelters [ Time Frame: Up to 24 months ]Number of influenza-positive participants identified through on-site molecular testing in the intervention period that were treated with an antiviral
- Number of Participants That Drop Out of Study [ Time Frame: Up to 24 months ]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
- Number of Participants That Show Non-compliance With Study Drug [ Time Frame: Up to 24 months ]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).
- Number of Laboratory-confirmed Influenza Cases That Report Fever [ Time Frame: Up to 24 months ]Based on self-report of new or worsening fever in the past 7 days; not gold standard measurement
- Influenza Viral RNA Levels [ Time Frame: Up to 24 months ]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.
- Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7 [ Time Frame: Up to 24 months ]Measured at subject follow-up visits with nasal swabs provided to study staff; provided subject has not become lost to follow up.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 3 Months and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141917
| United States, Washington | |
| Mary's Place Burien | |
| Burien, Washington, United States, 98146 | |
| Compass Housing Alliance at First Presbyterian | |
| Seattle, Washington, United States, 98104 | |
| Downtown Emergency Service Center Shelter | |
| Seattle, Washington, United States, 98104 | |
| ROOTS Young Adult Shelter | |
| Seattle, Washington, United States, 98105 | |
| Compass Housing Alliance Blaine Center Men's Shelter | |
| Seattle, Washington, United States, 98109 | |
| Mary's Place North Seattle | |
| Seattle, Washington, United States, 98133 | |
| St Martin De Porres Shelter | |
| Seattle, Washington, United States, 98134 | |
| Compass Housing Alliance Jan & Peter's Place Women's Shelter | |
| Seattle, Washington, United States, 98144 | |
| Mary's Place White Center | |
| Seattle, Washington, United States, 98146 | |
| Principal Investigator: | Helen Y Chu, MD, MPH | University of Washington |
Documents provided by Helen Chu, University of Washington:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Helen Chu, Assistant Professor, School of Medicine: Division of Allergy & Infectious Diseases, University of Washington |
| ClinicalTrials.gov Identifier: | NCT04141917 |
| Other Study ID Numbers: |
STUDY00007800 |
| First Posted: | October 28, 2019 Key Record Dates |
| Results First Posted: | June 22, 2022 |
| Last Update Posted: | June 22, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | We do not currently expect to share specimens with outside investigators, but if compelling opportunities arise that will advance the overall objectives of this research, the Executive Committee of the study will consider such requests. They alone have the authority to make such decisions. All biospecimens (nasal swabs) will be coded and identifiable through the study's main database. Any specimens shared with external investigators (if deemed appropriate by the Executive Committee) will have identifiers removed prior to sharing. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Tamiflu Oseltamivir Baloxavir Influenza |
Flu Rapid Test Xofluza |
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Influenza, Human Virus Diseases Respiratory Tract Infections Infections |
Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases |