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Curing HCV in Incarcerated Patients (CHIP)

Primary Purpose

Hepatitis C, Chronic

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Patients receiving Sof/Vel (Epclusa) and Navigation services
Sponsored by
San Francisco Department of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C, Chronic, Jail, Patient Navigation, Incarcerated Population, HCV, Sofosbuvir/Velpatasvir, Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a detectable HCV viral load
  • no medical contraindications to treatment, including limited life expectancy of less than 12-months due to non-liver related comorbid conditions or renal failure with creatinine clearance of < 30 mL/min.
  • Must start HCV treatment while detained
  • HIV positive or negative status
  • HBV positive or negative status
  • treatment-naïve or experienced
  • with or without cirrhosis

Exclusion Criteria:

  • a limited life expectancy of less than 12-months due to non-liver related comorbid conditions
  • current or history of decompensated cirrhosis, defined as presence of ascites, hepatic encephalopathy, or variceal bleeding within the past 6 months.
  • severe renal impairment defined as creatinine clearance of < 30 mL/min or end stage renal disease (ESRD) on hemodialysis
  • pregnant

Sites / Locations

  • Jail Health Services

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Navigation services with sof/vel therapy

Arm Description

This a single group demonstration project in which, patients are treated with the FDA-approved drug, Sofosbuvir/Velpatasvir (Epclusa). If a patients is released during their treatment regimen, they will receive patient navigation services to continue their care and treatment in the community.

Outcomes

Primary Outcome Measures

SVR12 of 70% or greater
The primary objective is to implement a feasible HCV treatment program in an urban jail setting, City & County of San Francisco, over a 12 month period, with demonstration of a SVR12 of 70% or greater among inmates who initiates HCV treatment

Secondary Outcome Measures

Full Information

First Posted
January 10, 2017
Last Updated
May 30, 2017
Sponsor
San Francisco Department of Public Health
Collaborators
University of California, San Francisco, San Francisco Study Center, Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03018353
Brief Title
Curing HCV in Incarcerated Patients
Acronym
CHIP
Official Title
Curing HCV in Incarcerated Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2017 (Actual)
Primary Completion Date
March 4, 2018 (Anticipated)
Study Completion Date
June 4, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Francisco Department of Public Health
Collaborators
University of California, San Francisco, San Francisco Study Center, Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess the feasibility of a HCV treatment program in the San Francisco City & County Jail. The Jail Health Services will treat 100 patients using the FDA approved combination treatment, sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during incarceration and after their release (if applicable).
Detailed Description
Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will be conducted in the San Francisco County Jails. Jail settings can provide an optimal opportunity to screen for HCV, initiate curative treatment, and link patients to community HCV providers to complete their treatment. This demonstration project will be funded by the Gilead's Investigator Sponsored Research. The purpose is to assess the feasibility of treating inmates with the FDA approved combination oral treatment, sofosbuvir/velpatasvir, Epclusa®. The San Francisco Department of Public Health's Jail Health Services will treat 100 patients. Intensive patient navigators will be an essential component for treatment to ensure medication adherence and achieve SVR for those who are discharged from jail prior to HCV treatment completion. Navigators will provide short-term case management services by linking patients to medical and social support services. This demonstration project will be facilitated by the Jail Health Services' HIV & Integrated Services (formerly Forensic AIDS Project).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Hepatitis C, Chronic, Jail, Patient Navigation, Incarcerated Population, HCV, Sofosbuvir/Velpatasvir, Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Navigation services with sof/vel therapy
Arm Type
Other
Arm Description
This a single group demonstration project in which, patients are treated with the FDA-approved drug, Sofosbuvir/Velpatasvir (Epclusa). If a patients is released during their treatment regimen, they will receive patient navigation services to continue their care and treatment in the community.
Intervention Type
Drug
Intervention Name(s)
Patients receiving Sof/Vel (Epclusa) and Navigation services
Intervention Description
Implementing HCV treatment in the jails using FDA-approved medications and continuing there treatment in the community if they are released during their treatment regimen.
Primary Outcome Measure Information:
Title
SVR12 of 70% or greater
Description
The primary objective is to implement a feasible HCV treatment program in an urban jail setting, City & County of San Francisco, over a 12 month period, with demonstration of a SVR12 of 70% or greater among inmates who initiates HCV treatment
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a detectable HCV viral load no medical contraindications to treatment, including limited life expectancy of less than 12-months due to non-liver related comorbid conditions or renal failure with creatinine clearance of < 30 mL/min. Must start HCV treatment while detained HIV positive or negative status HBV positive or negative status treatment-naïve or experienced with or without cirrhosis Exclusion Criteria: a limited life expectancy of less than 12-months due to non-liver related comorbid conditions current or history of decompensated cirrhosis, defined as presence of ascites, hepatic encephalopathy, or variceal bleeding within the past 6 months. severe renal impairment defined as creatinine clearance of < 30 mL/min or end stage renal disease (ESRD) on hemodialysis pregnant
Facility Information:
Facility Name
Jail Health Services
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared with other outside researchers who are not participating in this pilot demonstration project.

Learn more about this trial

Curing HCV in Incarcerated Patients

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