<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03018353</url>
  </required_header>
  <id_info>
    <org_study_id>IN-US-337-1941</org_study_id>
    <nct_id>NCT03018353</nct_id>
  </id_info>
  <brief_title>Curing HCV in Incarcerated Patients</brief_title>
  <acronym>CHIP</acronym>
  <official_title>Curing HCV in Incarcerated Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Francisco Department of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>San Francisco Study Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>San Francisco Department of Public Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess&#xD;
      the feasibility of a HCV treatment program in the San Francisco City &amp; County Jail. The Jail&#xD;
      Health Services will treat 100 patients using the FDA approved combination treatment,&#xD;
      sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during incarceration and&#xD;
      after their release (if applicable).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will be&#xD;
      conducted in the San Francisco County Jails. Jail settings can provide an optimal opportunity&#xD;
      to screen for HCV, initiate curative treatment, and link patients to community HCV providers&#xD;
      to complete their treatment. This demonstration project will be funded by the Gilead's&#xD;
      Investigator Sponsored Research. The purpose is to assess the feasibility of treating inmates&#xD;
      with the FDA approved combination oral treatment, sofosbuvir/velpatasvir, Epclusa®. The San&#xD;
      Francisco Department of Public Health's Jail Health Services will treat 100 patients.&#xD;
      Intensive patient navigators will be an essential component for treatment to ensure&#xD;
      medication adherence and achieve SVR for those who are discharged from jail prior to HCV&#xD;
      treatment completion. Navigators will provide short-term case management services by linking&#xD;
      patients to medical and social support services. This demonstration project will be&#xD;
      facilitated by the Jail Health Services' HIV &amp; Integrated Services (formerly Forensic AIDS&#xD;
      Project).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">March 5, 2017</start_date>
  <completion_date type="Anticipated">June 4, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 4, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SVR12 of 70% or greater</measure>
    <time_frame>12 months</time_frame>
    <description>The primary objective is to implement a feasible HCV treatment program in an urban jail setting, City &amp; County of San Francisco, over a 12 month period, with demonstration of a SVR12 of 70% or greater among inmates who initiates HCV treatment</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hepatitis C, Chronic</condition>
  <arm_group>
    <arm_group_label>Navigation services with sof/vel therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Patients receiving Sof/Vel (Epclusa) and Navigation services</intervention_name>
    <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.</description>
    <arm_group_label>Navigation services with sof/vel therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a detectable HCV viral load&#xD;
&#xD;
          -  no medical contraindications to treatment, including limited life expectancy of less&#xD;
             than 12-months due to non-liver related comorbid conditions or renal failure with&#xD;
             creatinine clearance of &lt; 30 mL/min.&#xD;
&#xD;
          -  Must start HCV treatment while detained&#xD;
&#xD;
          -  HIV positive or negative status&#xD;
&#xD;
          -  HBV positive or negative status&#xD;
&#xD;
          -  treatment-naïve or experienced&#xD;
&#xD;
          -  with or without cirrhosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a limited life expectancy of less than 12-months due to non-liver related comorbid&#xD;
             conditions&#xD;
&#xD;
          -  current or history of decompensated cirrhosis, defined as presence of ascites, hepatic&#xD;
             encephalopathy, or variceal bleeding within the past 6 months.&#xD;
&#xD;
          -  severe renal impairment defined as creatinine clearance of &lt; 30 mL/min or end stage&#xD;
             renal disease (ESRD) on hemodialysis&#xD;
&#xD;
          -  pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jail Health Services</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>May 30, 2017</last_update_submitted>
  <last_update_submitted_qc>May 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Francisco Department of Public Health</investigator_affiliation>
    <investigator_full_name>Lisa Pratt, MD</investigator_full_name>
    <investigator_title>Medical Director, Jail Health Services</investigator_title>
  </responsible_party>
  <keyword>Hepatitis C, Chronic</keyword>
  <keyword>Jail</keyword>
  <keyword>Patient Navigation</keyword>
  <keyword>Incarcerated Population</keyword>
  <keyword>HCV</keyword>
  <keyword>Sofosbuvir/Velpatasvir</keyword>
  <keyword>Hepatitis C</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sofosbuvir-velpatasvir drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD will be shared with other outside researchers who are not participating in this pilot demonstration project.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03018353
org study id: IN-US-337-1941
nct id: NCT03018353
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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).
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).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: SVR12 of 70% or greater
time frame: 12 months
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
arm group label: Navigation services with sof/vel therapy
arm group type: Other
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: Patients receiving Sof/Vel (Epclusa) and Navigation services
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.
arm group label: Navigation services with sof/vel therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: San Francisco Department of Public Health
investigator full name: Lisa Pratt, MD
investigator title: Medical Director, Jail Health Services
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Sofosbuvir-velpatasvir drug combination
sharing ipd: No
ipd description: No IPD will be shared with other outside researchers who are not participating in this pilot demonstration project.