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Curing HCV in Incarcerated Patients (CHIP)

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ClinicalTrials.gov Identifier: NCT03018353
Recruitment Status : Unknown
Verified May 2017 by Lisa Pratt, MD, San Francisco Department of Public Health.
Recruitment status was:  Enrolling by invitation
First Posted : January 12, 2017
Last Update Posted : June 1, 2017
Sponsor:
Collaborators:
University of California, San Francisco
San Francisco Study Center
Gilead Sciences
Information provided by (Responsible Party):
Lisa Pratt, MD, San Francisco Department of Public Health

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).

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Patients receiving Sof/Vel (Epclusa) and Navigation services Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Curing HCV in Incarcerated Patients
Actual Study Start Date : March 5, 2017
Estimated Primary Completion Date : March 4, 2018
Estimated Study Completion Date : June 4, 2018

Arm Intervention/treatment
Navigation services with sof/vel therapy
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.
Drug: Patients receiving Sof/Vel (Epclusa) and Navigation services
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 Measures :
  1. SVR12 of 70% or greater [ Time Frame: 12 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018353


Locations
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United States, California
Jail Health Services
San Francisco, California, United States, 94103
Sponsors and Collaborators
San Francisco Department of Public Health
University of California, San Francisco
San Francisco Study Center
Gilead Sciences

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Responsible Party: Lisa Pratt, MD, Medical Director, Jail Health Services, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT03018353     History of Changes
Other Study ID Numbers: IN-US-337-1941
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other outside researchers who are not participating in this pilot demonstration project.

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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
Keywords provided by Lisa Pratt, MD, San Francisco Department of Public Health:
Hepatitis C, Chronic
Jail
Patient Navigation
Incarcerated Population
HCV
Sofosbuvir/Velpatasvir
Hepatitis C
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Velpatasvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents