<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/NCT01717560</url>
  </required_header>
  <id_info>
    <org_study_id>0308006281</org_study_id>
    <nct_id>NCT01717560</nct_id>
  </id_info>
  <brief_title>Hepatitis C Treatment in Underserved Populations</brief_title>
  <official_title>Hepatitis C Treatment in Underserved Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brian Edlin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>State University of New York - Downstate Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the feasibility, safety, and effectiveness of&#xD;
      treating persons who are actively using illicit drugs for hepatitis C using a collaborative,&#xD;
      multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and&#xD;
      minimizing barriers to treatment we can enable drug users to receive effective treatment for&#xD;
      hepatitis C.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study examines the feasibility of integrated treatment for hepatitis C in active IDUs&#xD;
      using a client-centered, multidisciplinary model that combines expert care in five domains:&#xD;
      (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c)&#xD;
      psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive,&#xD;
      client-centered, case management. The Weill Cornell Medical College Center for the Study of&#xD;
      Hepatitis C collaborates with community-based organizations providing services to injection&#xD;
      drug users to provide multidisciplinary, integrated care using a model that combines the&#xD;
      resources of culturally appropriate community-based agencies with those of a state-of-the-art&#xD;
      tertiary care center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>February 2005</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <phase>N/A</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>Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.</measure>
    <time_frame>24 weeks after completion of antiviral treatment</time_frame>
    <description>SVR is measured 24 weeks after completion of antiviral treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>completion of medical and psychiatric evaluation for antiviral therapy</measure>
    <time_frame>Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>initiation of antiviral therapy</measure>
    <time_frame>Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adherence to antiviral therapy</measure>
    <time_frame>Weekly up to 48 weeks</time_frame>
    <description>Adherence is measured weekly during the duration of prescribed antiviral therapy. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient's characteristics, the regimen, and the response to therapy.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>completion of antiviral therapy</measure>
    <time_frame>Completion is recorded at the time prescribed antiviral therapy is discontinued, whether that happens when the prescribed duration of therapy is complete or before. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>levels of alcohol and illicit drug use</measure>
    <time_frame>Weekly up to 96 weeks</time_frame>
    <description>Measured weekly during antiviral therapy and monthly before and after therapy for the duration of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>entry into treatment for substance use</measure>
    <time_frame>Monthly up to 24 months</time_frame>
    <description>Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>entry into treatment for another unaddressed medical or psychiatric condition</measure>
    <time_frame>Monthly up to 24 months</time_frame>
    <description>Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropsychiatric side effects, including depression and hostility/irritability</measure>
    <time_frame>Monthly up to 72 weeks</time_frame>
    <description>Measured monthly during prescribed course of antiviral therapy and for 24 weeks thereafter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treatment-limiting systemic, hematologic, or other side effects</measure>
    <time_frame>Weekly up to 72 weeks</time_frame>
    <description>Measured weekly during prescribed course of antiviral therapy and then monthly or quarterly thereafter (TSH, for example, is measured every 3 months during and after treatment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>other adverse events or adverse effects</measure>
    <time_frame>Monthly up to 72 weeks</time_frame>
    <description>Measured monthly during prescribed course of antiviral therapy or as patients bring adverse events or effects to attention of physicians or study staff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reinfection</measure>
    <time_frame>Quarterly up to 10 years</time_frame>
    <description>Patients are monitored at 3-month intervals for reinfection. This will continue as long as possible after completion of antiviral therapy.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <condition>Illicit Drug Use</condition>
  <arm_group>
    <arm_group_label>Collaborative multidisciplinary integrated care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Collaborative, multidisciplinary, integrated care for hepatitis C</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collaborative, multidisciplinary, integrated care</intervention_name>
    <description>Collaborative, multidisciplinary, integrated care for hepatitis C&#xD;
multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management.</description>
    <arm_group_label>Collaborative multidisciplinary integrated care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Used heroin, cocaine, or injected other drugs for at least 1 year&#xD;
&#xD;
          -  Have used heroin, cocaine and/or methamphetamine within the last 30 days&#xD;
&#xD;
          -  Test positive for HCV antibody&#xD;
&#xD;
          -  Are interested in being evaluated for HCV treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons who are obviously intoxicated, incoherent or otherwise unable to give informed&#xD;
             consent are excluded from participation. Such persons may participate in the study if&#xD;
             they return at a later date and are capable of providing informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian R. Edlin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College, Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for the Study of Hepatitis C, Weill Medical College, Cornell University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>April 29, 2008</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Weill Medical College of Cornell University</investigator_affiliation>
    <investigator_full_name>Brian Edlin</investigator_full_name>
    <investigator_title>Associate Professor of Medicine and Public Health</investigator_title>
  </responsible_party>
  <keyword>chronic hepatitis C</keyword>
  <keyword>illicit drug use</keyword>
  <keyword>Substance-Related Disorders</keyword>
  <keyword>multidisciplinary care</keyword>
  <keyword>integrated care</keyword>
  <keyword>mental health care</keyword>
  <keyword>intensive case management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT01717560
org study id: 0308006281
nct id: NCT01717560
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to examine the feasibility, safety, and effectiveness of
      treating persons who are actively using illicit drugs for hepatitis C using a collaborative,
      multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and
      minimizing barriers to treatment we can enable drug users to receive effective treatment for
      hepatitis C.
This study examines the feasibility of integrated treatment for hepatitis C in active IDUs
      using a client-centered, multidisciplinary model that combines expert care in five domains:
      (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c)
      psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive,
      client-centered, case management. The Weill Cornell Medical College Center for the Study of
      Hepatitis C collaborates with community-based organizations providing services to injection
      drug users to provide multidisciplinary, integrated care using a model that combines the
      resources of culturally appropriate community-based agencies with those of a state-of-the-art
      tertiary care center.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.
time frame: 24 weeks after completion of antiviral treatment
description: SVR is measured 24 weeks after completion of antiviral treatment
measure: completion of medical and psychiatric evaluation for antiviral therapy
time frame: Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases.
measure: initiation of antiviral therapy
time frame: Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases.
measure: adherence to antiviral therapy
time frame: Weekly up to 48 weeks
description: Adherence is measured weekly during the duration of prescribed antiviral therapy. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient's characteristics, the regimen, and the response to therapy.)
measure: completion of antiviral therapy
time frame: Completion is recorded at the time prescribed antiviral therapy is discontinued, whether that happens when the prescribed duration of therapy is complete or before. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient.)
measure: levels of alcohol and illicit drug use
time frame: Weekly up to 96 weeks
description: Measured weekly during antiviral therapy and monthly before and after therapy for the duration of follow-up
measure: entry into treatment for substance use
time frame: Monthly up to 24 months
description: Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
measure: entry into treatment for another unaddressed medical or psychiatric condition
time frame: Monthly up to 24 months
description: Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
measure: neuropsychiatric side effects, including depression and hostility/irritability
time frame: Monthly up to 72 weeks
description: Measured monthly during prescribed course of antiviral therapy and for 24 weeks thereafter
measure: treatment-limiting systemic, hematologic, or other side effects
time frame: Weekly up to 72 weeks
description: Measured weekly during prescribed course of antiviral therapy and then monthly or quarterly thereafter (TSH, for example, is measured every 3 months during and after treatment)
measure: other adverse events or adverse effects
time frame: Monthly up to 72 weeks
description: Measured monthly during prescribed course of antiviral therapy or as patients bring adverse events or effects to attention of physicians or study staff
measure: reinfection
time frame: Quarterly up to 10 years
description: Patients are monitored at 3-month intervals for reinfection. This will continue as long as possible after completion of antiviral therapy.
arm group label: Collaborative multidisciplinary integrated care
arm group type: Experimental
description: Collaborative, multidisciplinary, integrated care for hepatitis C
intervention type: Other
intervention name: Collaborative, multidisciplinary, integrated care
description: Collaborative, multidisciplinary, integrated care for hepatitis C
multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management.
arm group label: Collaborative multidisciplinary integrated care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian R. Edlin, MD
role: Principal Investigator
affiliation: Weill Medical College, Cornell University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Weill Medical College of Cornell University
investigator full name: Brian Edlin
investigator title: Associate Professor of Medicine and Public Health
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic