CClinicalTrials.gg
Status unknownNCT03018353CHIPUpdated Jun 1, 2017

Curing HCV in Incarcerated Patients

A Phase 4 interventional study of Patients receiving Sof/Vel (Epclusa) and Navigation services in Hepatitis C, Chronic, sponsored by San Francisco Department of Public Health. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-01.

Sponsored by San Francisco Department of Public Health · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Hepatitis C, Chronic

Keywords

  • Hepatitis C, Chronic
  • Jail
  • Patient Navigation
  • Incarcerated Population
  • HCV
  • Sofosbuvir/Velpatasvir
  • Hepatitis C
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's planned enrollment of 100 is above the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

San Francisco Department of Public Health is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    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

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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

07

Study locations

1 site
  • Jail Health Services
    San Francisco, California 94103, United States
08

References and documents

Individual participant data

Plan to share: No — No IPD will be shared with other outside researchers who are not participating in this pilot demonstration project.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03018353
Lead sponsor
San Francisco Department of Public Health
Collaborators
University of California, San Francisco, San Francisco Study Center, Gilead Sciences
Responsible party
Lisa Pratt, MD (Medical Director, Jail Health Services, San Francisco Department of Public Health) — Principal investigator
First posted
Jan 12, 2017
Start date
Mar 5, 2017
Primary completion
Mar 4, 2018 (estimated)
Completion
Jun 4, 2018 (estimated)
Last update
Jun 1, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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