Eliminating Hepatitis C Virus

Description

Initially, HCV Informatics (C-IT) will be used to filter the EMR data of the one million people who receive care at Mount Sinai and identify candidates for HCV testing (baby boomers, patients with HIV infection) and candidates for HCV treatment (patients with positive test results for HCV RNA and no record of treatment).once treatment candidates have been identified through this proactive approach, their providers will be directly notified. HCV champions and patient navigators will be used to further lower barriers to the delivery of HCV care. They will be co-located at non-hepatology care sites and will help deliver open-label HCV treatment as part of standard medical care to 500 HIV/HCV co-infected patients and 200 patients with type 2 diabetes.

Study Start Date

January, 01 2018

Estimated Completion Date

August 2021

Interventions

No interventions cited

Study ID

Icahn School of Medicine at Mount Sinai -- GCO 17-1070

Status

Recruiting

Trial ID

NCT03401697

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

700

Sponsor

Icahn School of Medicine at Mount Sinai

Inclusion Criteria

    Inclusion criteria for HCV treatment in patients with HIV/HCV co-infection
  • 18 years of age or older
  • HCV RNA positive
  • Any HCV genotype
  • Documented infection with HIV, with the following additional criteria:
  • Patients on HAART should be on a stable regimen for 4 weeks, with a CD4 count > 100, and an HIV viral load < 50 prior to initiation of HCV therapy Patients not on HAART should have a CD4 count > 350
  • Expected life expectancy sufficient to receive a benefit from HCV cure
  • No conditions that are contraindications for the use of HCV medications Inclusion criteria for HCV treatment in patients with type 2 diabetes
  • 18 years of age or older
  • HCV RNA positive
  • Any HCV genotype
  • Documented diagnosis of type 2 diabetes, confirmed by medical record review by the study endocrinologist, Dr. Sherley Abraham
  • Expected life expectancy sufficient to receive a benefit from HCV cure

Exclusion Criteria

  • No conditions that are contraindications for the use of HCV medications

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Icahn School of Medicine at Mount Sinai - New York, New York 46.8 miles Andrea D Branch PhD 212-659-8371 andrea.branch@mssm.edu

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