An observational study in Hepatitis C, HIV and Type2 Diabetes, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-24.
Sponsored by Icahn School of Medicine at Mount Sinai · Observational
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.
People who receive care at Mount Sinai and candidates for HCV testing or HCV treatment and co-located at non-hepatology care sites.
Inclusion criteria for HCV treatment in patients with HIV/HCV co-infection
Inclusion criteria for HCV treatment in patients with type 2 diabetes
Exclusion Criteria:
Patients with HIV/HCV co-infection
Patients with Type 2 Diabetes
Change in the Number of Patients with sCD163 above the upper limit of normal
Change in the Number of Patients with sCD163 above the upper limit of normal at 3 years from baseline
Time frame: baseline and 3 years
Number of Type 2 Diabetes patients that initiate HCV treatment
The number of patients that initiate HCV treatment per month per patient navigator.
Time frame: 3 years
sCD163
blood sample for sC163, a marker of systemic inflammation.
Time frame: 3 years
Percentage of patients in need of repeated re-treatment
The percentage of patients in need of repeated re-treatment whose quasispecies analysis indicates that re-infection is the likely cause of recurrent HCV viremia. If such patients are identified, they will be referred for risk reduction counseling.
Time frame: 3 years
HOMA-IR
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.
Time frame: 3 years
Number of resistance associated variant (RAV)
Resistance associated variant (RAV) testing from up to 50 patients who fail treatment or become re-infected
Time frame: 3 years
FIB-4 score
The FIB-4 score of HCV positive patients with type 2 diabetes. The Fibrosis 4 score is a non-invasive scoring system based on several laboratory tests that help to estimate the amount of scarring in the liver. This score has been studied in liver disease due to Hepatitis C and NASH. Formula : ( Age x AST ) / ( Platelets x ( sqr ( ALT )
Time frame: 3 years
HCV cure rate
The HCV cure rate among patients with type 2 diabetes
Time frame: 3 years
Plan to share: Yes — Direct outreach to providers (giving them the names of their patients who are candidates for treatment)
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai