Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06207058 |
| Other study ID # |
Tricore |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2024 |
| Est. completion date |
July 1, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Tricore, Inc |
| Contact |
Karissa Culbreath, PhD |
| Phone |
5059388461 |
| Email |
karissa.culbreath[@]tricore.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
