Trial · NCT04141917
Test-and-treat for Influenza in Homeless Shelters
NCT04141917, Phase 4, Terminated, University of Washington; results first posted 2022-06-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Test-and-treat for Influenza in Homeless Shelters. Trials, record NCT04141917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04141917
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Test-and-treat for Influenza in Homeless Shelters
- NCT number
- NCT04141917
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 1,618 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Influenza, Respiratory Viral Infection
- Interventions
- Point-of-care molecular testing and treatment of influenza
- First posted
- 2019-10-28
- Last updated
- 2022-06-22
- Results first posted
- 2022-06-22
- Limitations and caveats
Decline in influenza activity following the advent of SARS-CoV-2 public health mitigation measures led to early termination of study for operational futility purposes. Low infection detection and study power after year 1 also limited our ability to conduct statistical analyses on several intended secondary outcomes.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period | 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. |
| Secondary | Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters | Up to 24 months | Number of participants/participant encounters with les than 48 hours between symptom onset until diagnosis with RT-PCR. |
| Secondary | Feasibility of Implementation of Influenza Treatment in Shelters | 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 |
| Secondary | Number of Participants That Drop Out of Study | 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 |
| Secondary | Number of Participants That Show Non-compliance With Study Drug | 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). |
| Secondary | Number of Laboratory-confirmed Influenza Cases That Report Fever | Up to 24 months | Based on self-report of new or worsening fever in the past 7 days; not gold standard measurement |
| Secondary | Influenza Viral RNA Levels | 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. |
| Secondary | Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period | Year 1 of the intervention (4.5 months) | Due to the impact of COVID-19 mitigation efforts on reduced influenza transmission in Year 2 of the study and subsequent early stop due to operational futility, the analysis population for the primary outcome only includes unique participants who enrolled in Year 1 of the study (11/15/19 - 3/31/20). For this primary outcome measure, we used the number of unique participants in Year 1 as the denominator rather than all participant enrollments. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters | Up to 24 months | Includes all participant encounters from study Years 1 and 2. 153 participant encounters were missing this data because they were asymptomatic enrollments conducted once monthly at all shelters between 11/15/2019 and 3/31/2020. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Feasibility of Implementation of Influenza Treatment in Shelters | Up to 24 months | This outcome can only be assessed among participants enrollments from the intervention period as those in the control period (standard influenza surveillance) were not eligible for antiviral treatment. Those that reported symptom onset ≥48 hours that were enrolled in the intervention period were dropped from the overall number of participants analyzed. The analysis population includes only influenza-positive cases that were detected using an on-site molecular test. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Drop Out of Study | Up to 24 months | Only participant enrollments from the intervention period that tested positive for influenza at baseline enrollment with an on-site molecular test and received an antiviral are included in this analysis population as participant enrollments under the standard influenza surveillance period did not receive follow-up. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Show Non-compliance With Study Drug | Up to 24 months | This analysis population includes all participants that received oseltamivir as an antiviral and returned for at least one follow-up study visit when a number of doses of the medication was reported to study staff. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Laboratory-confirmed Influenza Cases That Report Fever | Up to 24 months | All influenza positive cases detected in study Years 1 and 2; there were no cases of influenza detected in year 2 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Influenza Viral RNA Levels | Up to 24 months | All influenza-positive specimen detected through RT-PCR in study Years 1 and 2. One individual in the standard surveillance period was coinfected with both Influenza A and Influenza B, therefore these row numbers are not mutually exclusive. | Cycle threshold value | MEAN |
| SECONDARY | Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7 | Up to 24 months | Only includes influenza-positive samples from participant enrollments collected in the intervention period and detected with an on-site molecular test. Of the 21 participants that received an antiviral and, according to the protocol, should have returned for follow-up sample collect and study visits, only 14 returned on day 2/3 and only 1 returned for day 2/3 and day 5/6/7 study visits. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period | Standard Influenza Surveillance Period | 23 | Participants | ||
| Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period | Point-of-care Molecular Testing and Treatment of Influenza Period | 32 | Participants | ||
| Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters | Standard Influenza Surveillance Period | 266 | Participants | ||
| Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters | Point-of-care Molecular Testing and Treatment of Influenza Period | 308 | Participants | ||
| Feasibility of Implementation of Influenza Treatment in Shelters | Point-of-care Molecular Testing and Treatment of Influenza Period | 21 | Participants | ||
| Number of Participants That Drop Out of Study | Point-of-care Molecular Testing and Treatment of Influenza Period | 1 | Participants | ||
| Number of Participants That Show Non-compliance With Study Drug | Point-of-care Molecular Testing and Treatment of Influenza Period | 1 | Participants | ||
| Number of Laboratory-confirmed Influenza Cases That Report Fever | Standard Influenza Surveillance Period | 12 | Participants | ||
| Number of Laboratory-confirmed Influenza Cases That Report Fever | Point-of-care Molecular Testing and Treatment of Influenza Period | 16 | Participants | ||
| Influenza Viral RNA Levels | Standard Influenza Surveillance Period | Influenza A | 19.22 | Inter-Quartile Range 16.50 to 22.19 | Cycle threshold value |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Surveillance Year 1 | STARTED | Sequence A | 63 | 3 |
| Surveillance Year 1 | STARTED | Sequence B | 76 | 2 |
| Surveillance Year 1 | STARTED | Sequence C | 81 | 2 |
| Surveillance Year 1 | STARTED | Sequence D | 324 | 2 |
| Surveillance Year 1 | COMPLETED | Sequence A | 63 | 3 |
| Surveillance Year 1 | COMPLETED | Sequence B | 76 | 2 |
| Surveillance Year 1 | COMPLETED | Sequence C | 81 | 2 |
| Surveillance Year 1 | COMPLETED | Sequence D | 324 | 2 |
| Surveillance Year 1 | NOT COMPLETED | Sequence A | 0 | 0 |
| Surveillance Year 1 | NOT COMPLETED | Sequence B | 0 | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea or vomiting | Gastrointestinal disorders | Standard Influenza Surveillance Period | 0 | 853 | |
| other | Nausea or vomiting | Gastrointestinal disorders | Point-of-care Molecular Testing and Treatment of Influenza Period | 2 | 765 | |
| other | Ear pain or ear discharge | Ear and labyrinth disorders | Standard Influenza Surveillance Period | 0 | 853 | |
| other | Ear pain or ear discharge | Ear and labyrinth disorders | Point-of-care Molecular Testing and Treatment of Influenza Period | 1 | 765 | |
| other | Diarrhea | Gastrointestinal disorders | Standard Influenza Surveillance Period | 0 | 853 | |
| other | Diarrhea | Gastrointestinal disorders | Point-of-care Molecular Testing and Treatment of Influenza Period | 2 | 765 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Standard Influenza Surveillance Period | 0 | 853 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Point-of-care Molecular Testing and Treatment of Influenza Period | 1 | 765 | |
| other | Nasopharyngitis | General disorders | Standard Influenza Surveillance Period | 0 | 853 | |
| other | Nasopharyngitis | General disorders | Point-of-care Molecular Testing and Treatment of Influenza Period | 1 | 765 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Influenza Surveillance Period | 0 | 853 |
| Total, all-cause mortality | Point-of-care Molecular Testing and Treatment of Influenza Period | 0 | 765 |
| Total, other adverse events | Standard Influenza Surveillance Period | 0 | 853 |
| Total, other adverse events | Point-of-care Molecular Testing and Treatment of Influenza Period | 5 | 765 |
| Total, serious adverse events | Standard Influenza Surveillance Period | 0 | 853 |
| Total, serious adverse events | Point-of-care Molecular Testing and Treatment of Influenza Period | 0 | 765 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard Influenza Surveillance Period vs Point-of-care Molecular Testing and Treatment of Influenza Period: Number of Laboratory-confirmed Influenza Cases That Report Fever | Trial comparisons |
Standard Influenza Surveillance Period vs Point-of-care Molecular Testing and Treatment of Influenza Period: Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period | Trial comparisons |
| Standard Influenza Surveillance Period vs Point-of-care Molecular Testing and Treatment of Influenza Period: deaths from any cause | Trial comparisons |
Standard Influenza Surveillance Period vs Point-of-care Molecular Testing and Treatment of Influenza Period: Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters | Trial comparisons |
| Standard Influenza Surveillance Period vs Point-of-care Molecular Testing and Treatment of Influenza Period: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04141917
GET https://conductscience.org/api/trials/v1/NCT04141917/flow?page=2