Eliminating Hepatitis C Virus

NCT ID: NCT03401697

Last Updated: 2021-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-23

Study Completion Date

2021-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C HIV Type2 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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HIV/HCV Co-infected

Patients with HIV/HCV co-infection

No interventions assigned to this group

Type 2 Diabetes

Patients with Type 2 Diabetes

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Andrea Branch

Professor, Liver Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea D. Branch, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinia

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO 17-1070

Identifier Type: -

Identifier Source: org_study_id

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