Curing HCV in Incarcerated Patients

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03018353

Acronym

CHIP

Enrollment

100

Registered

2017-01-12

Start date

2017-03-05

Completion date

2018-06-04

Last updated

2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, Chronic, Jail, Patient Navigation, Incarcerated Population, HCV, Sofosbuvir/Velpatasvir, Hepatitis C

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).

Interventions

DRUGPatients 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
SVR12 of 70% or greater	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026