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ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals

TerminatedNA

Sponsor: Scripps Translational Science Institute

Conditions: Immunodeficiency, Immunosuppression, HIV Infections, Graft Versus Host Disease, Leukemia

Interventions: Access to Cue Health COVID-19 Remote testing and treatment for COVID-19

Countries: United States

The investigators will examine whether a combination of at-home nucleic acid amplification tests, on-demand telemedicine, and delivery of prescriptions such as Paxlovid quickly after testing positive for COVID-19, can reduce severe outcomes and hospitalization of immunocompromised patients and those who are 65 years and older. They will also analyze whether these efforts lower the cost of care compared to standard of care.

Eligibility overview

Sex: ALL

Age: 18 Years to 120 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Living in the United States
* 18 years or older
* Can read and understand English
* Use of smartphone with bluetooth, a camera and a compatible operating system (Android OS 9.0 or higher, Apple iOS 13.0 or higher)
* Vaccinated against COVID-19 (completed at least the initial course, e.g. at least 2 doses of -Moderna or Pfizer, one dose of J\&J)
* Willing and able to participate in study interventions including:

1. Use of smartphone, including camera and bluetooth
2. Upload verification of diagnosis, if needed
3. Completing Surveys
4. Use of Cue Health App
5. Use of MyDataHelps Web or App
* Immunocompromised due to disease or therapy, including:

1. Symptomatic HIV
2. Graft versus host disease
3. Immunoglobulin deficiency/Immunodeficiency
4. Immunosuppressive therapy
5. Leukemia
6. Lymphoma (Hodgkin or non-Hodgkin)
7. Metastatic Cancer
8. Multiple Myeloma
9. Solid organ malignancy
10. Transplant, hematopoietic stem cell
11. Transplant, solid organ
* Age 1. 65 years and older

Option if under 65 to share claims data as a member of one of the following insurance providers:

1. Anthem BlueCross and BlueShield
2. Anthem BlueCross
3. Empire BlueCross BlueShield
4. Empire BlueCross
5. Wellpoint
6. Carelon
7. Unicare
8. Simply Healthcare Plans
9. National Government Services, Inc.
10. MMM
11. Health Sun
12. HealthLink
13. Amerigroup
14. Medicare
15. Medicaid
16. Or another partner that can provide claims data on participant's behalf

Exclusion Criteria:

-Unable to meet inclusion criteria

Locations (1)

La Jolla, California, United States