Curing HCV in Incarcerated Patients

Hepatitis C, Chronic Clinical Trial

— CHIP  

Official title:

Curing HCV in Incarcerated Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03018353
• Other study ID #: IN-US-337-1941
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: January 10, 2017
• Last updated: May 30, 2017
• Start date: March 5, 2017
• Est. completion date: June 4, 2018

Study information

• Verified date: May 2017
• Source: San Francisco Department of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 4, 2018
• Est. primary completion date: March 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Jail Health Services	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
San Francisco Department of Public Health	Gilead, Inc. Investigator Sponsored Research, San Francisco Study Center, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months