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
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 | |
---|---|---|---|---|
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 |