Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT06207058
Status:
TERMINATED
Last Update Posted:
2025-05-23
First Post:
2024-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of a Screen and Treat Protocol for Influenza
Sponsor:
Tricore, Inc
Organization:
Study Overview
Official Title:
Evaluation of a Screen and Treat Protocol for Influenza in Socially Vulnerable Communities.
Status:
TERMINATED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Limited enrollment opportunities due to low rates of viral infections
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to demonstrate that the laboratory can mitigate respiratory virus transmission in underserved populations by using laboratory data to identify communities at risk for increase vial activity (hot spots) and intervening with a test-to-treat model provides increased access to influenza diagnostics and treatment in vulnerable and underserved communities.
Detailed Description:
The investigators have developed an analytic algorithm that uses measures from the CDC COVID-19 Hot Spot Criteria and Brown University School of Public Health to determine COVID-19 and Influenza Hot Spots and Testing Deserts, respectively. The Hot Spot designation was based on the CDC county-specific Hot Spot criteria that has been used to deploy resources for interventions (i.e., laboratory testing, community mitigation, health communications and health care) specific needs for the communities of interest. The CDC hot spot criteria is based on COVID-19 rates at the county level. The adaptations to the criteria allows interventions to focus on a concentrated community and deliver the interventions in places that the community is already engaging, such as community centers, senior centers and parks.
Through collaboration with local community centers, the investigators are able to deploy a mobile testing unit to a community center, park or senior center that is in close proximity to the identified neighborhood for rapid onsite testing for Influenza A\&B and SARS-CoV2 using the cobas Liat system.
New Mexico has adopted "New Mexico Board of Pharmacy Protocol for Pharmacists Prescribing of Dangerous Drugs in Conjunction with Point of Care Testing" (NMBOP POCT Protocol, Appendix 5) that allows pharmacists the prescriptive authority to prescribe Influenza antiviral therapy in conjunction with a positive point of care test (POCT). TriCore employs two (2) on-site clinical pharmacists who will follow all of the pharmacist mandates included in the regulation to prescribe and distribute Xofluza according to the approved protocol in the test-to-treat model presented in this study. The NMBOP PCOT Protocol documents the eligibility and requirements of the certified prescribing pharmacists (pharmacist) following this protocol.
The pharmacist will perform a screening physical assessment, health assessment and medical history for the patient. If the subject meets the inclusion criteria, they will have a point of care test performed. If the subject meets the exclusion criteria, they will be excluded from the study. Testing will be performed using the cobas® SARS-CoV-2 \& Influenza A/B assay on the cobas® Liat® system from a self-collected nasal swab. Subjects who test positive for influenza A or B will be prescribed Xofluza with no additional refills. The pharmacist will follow-up with the patient 24-48 hours following administration for evaluation of signs/symptoms and will refer the patient to their primary care provider, provider, or clinic for recommended laboratory testing and follow-up if appropriate.
All subjects eligible for Xofluza will receive patient education and counseling on drug information, adherence, side effects, and other patient educational materials, as appropriate. All subjects eligible for influenza antiviral therapy, but having contraindications to the therapy, or do not wish to use the therapy will be referred to their primary care provider, provider, or clinic for further evaluation.
Subjects testing positive for SARS-CoV-2 will be referred by the pharmacist to the subjects' primary care provider, provider, or clinic for further medical assessment and follow-up, if appropriate. Subjects testing negative for all targets (SARS-CoV-2 and Influenza A\&B) with a high index of suspicion for influenza, will be referred by the pharmacist to the subjects' primary care provider, provider, or clinic for further medical assessment and follow-up, if appropriate. All subjects will receive a follow-up call 14-days following the study visit to assess their symptom resolution and the impact of their illness on their well-being
The mobile testing unit will be deployed a minimum of 2 times per week following the determination of the influenza season by the New Mexico Department of Health. The investigators expect to screen 50-100 patients per week for the duration of the influenza season (approximately 12 weeks) for a total of 600-1,2000 patients. With an anticipated 10% positivity rate for influenza, the investigators expect at least 5-10 patients per week to be eligible for treatment for a total of 60-120 subjects eligible over the course of the study. All subjects will be provided a survey to evaluated their ability to access respiratory virus testing and their acceptance of and trust in using a mobile unit for access to treatment and therapeutics. Patients positive for SARS-CoV-2 will be counseled on options for treatment and follow up for COVID-19 infection. All subjects enrolled in the study will receive a follow-up phone call 14-days following the initial screening visit.
Through collaboration with local community centers, the investigators are able to deploy a mobile testing unit to a community center, park or senior center that is in close proximity to the identified neighborhood for rapid onsite testing for Influenza A\&B and SARS-CoV2 using the cobas Liat system.
New Mexico has adopted "New Mexico Board of Pharmacy Protocol for Pharmacists Prescribing of Dangerous Drugs in Conjunction with Point of Care Testing" (NMBOP POCT Protocol, Appendix 5) that allows pharmacists the prescriptive authority to prescribe Influenza antiviral therapy in conjunction with a positive point of care test (POCT). TriCore employs two (2) on-site clinical pharmacists who will follow all of the pharmacist mandates included in the regulation to prescribe and distribute Xofluza according to the approved protocol in the test-to-treat model presented in this study. The NMBOP PCOT Protocol documents the eligibility and requirements of the certified prescribing pharmacists (pharmacist) following this protocol.
The pharmacist will perform a screening physical assessment, health assessment and medical history for the patient. If the subject meets the inclusion criteria, they will have a point of care test performed. If the subject meets the exclusion criteria, they will be excluded from the study. Testing will be performed using the cobas® SARS-CoV-2 \& Influenza A/B assay on the cobas® Liat® system from a self-collected nasal swab. Subjects who test positive for influenza A or B will be prescribed Xofluza with no additional refills. The pharmacist will follow-up with the patient 24-48 hours following administration for evaluation of signs/symptoms and will refer the patient to their primary care provider, provider, or clinic for recommended laboratory testing and follow-up if appropriate.
All subjects eligible for Xofluza will receive patient education and counseling on drug information, adherence, side effects, and other patient educational materials, as appropriate. All subjects eligible for influenza antiviral therapy, but having contraindications to the therapy, or do not wish to use the therapy will be referred to their primary care provider, provider, or clinic for further evaluation.
Subjects testing positive for SARS-CoV-2 will be referred by the pharmacist to the subjects' primary care provider, provider, or clinic for further medical assessment and follow-up, if appropriate. Subjects testing negative for all targets (SARS-CoV-2 and Influenza A\&B) with a high index of suspicion for influenza, will be referred by the pharmacist to the subjects' primary care provider, provider, or clinic for further medical assessment and follow-up, if appropriate. All subjects will receive a follow-up call 14-days following the study visit to assess their symptom resolution and the impact of their illness on their well-being
The mobile testing unit will be deployed a minimum of 2 times per week following the determination of the influenza season by the New Mexico Department of Health. The investigators expect to screen 50-100 patients per week for the duration of the influenza season (approximately 12 weeks) for a total of 600-1,2000 patients. With an anticipated 10% positivity rate for influenza, the investigators expect at least 5-10 patients per week to be eligible for treatment for a total of 60-120 subjects eligible over the course of the study. All subjects will be provided a survey to evaluated their ability to access respiratory virus testing and their acceptance of and trust in using a mobile unit for access to treatment and therapeutics. Patients positive for SARS-CoV-2 will be counseled on options for treatment and follow up for COVID-19 infection. All subjects enrolled in the study will receive a follow-up phone call 14-days following the initial screening visit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: