<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/NCT03242655</url>
  </required_header>
  <id_info>
    <org_study_id>2016-6948</org_study_id>
    <secondary_id>K23DA039060-03PD</secondary_id>
    <nct_id>NCT03242655</nct_id>
  </id_info>
  <brief_title>HCV Group Evaluation and Treatment Uptake (HCV GET-UP) Intervention</brief_title>
  <official_title>Adaptation and Testing of a Primary Care HCV Group Medical Treatment Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      People who inject drugs (PWID) represent the overwhelming majority of both HCV and HIV/HCV&#xD;
      infected people in the United States. Though new, direct-acting HCV medications are highly&#xD;
      efficacious and have the potential to end the HCV epidemic, few PWIDs ever initiate&#xD;
      treatment. This study seeks to improve HCV treatment uptake and cure among HCV and HIV/HCV+&#xD;
      PWIDs by testing a primary care based HCV Group Evaluation and Treatment UPtake (GET-UP)&#xD;
      intervention. If efficacious, this innovative care intervention could provide a means to&#xD;
      reduce the growing mortality from HCV, as well as decrease the current reservoir for HCV&#xD;
      transmission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this proposal is to improve HCV (hepatitis C virus) treatment uptake among&#xD;
      current and former injection drug users (IDUs) by testing an innovative, primary care based&#xD;
      HCV Group Evaluation and Treatment UPtake (HCV GET-UP) intervention. IDUs make up the&#xD;
      majority of the 4 million Americans chronically infected with HCV, and up to 90% of HIV+ IDUs&#xD;
      are infected with HCV. In the U.S., HCV is the leading cause of end-stage liver disease and&#xD;
      hepatocellular carcinoma, and the most common indication for liver transplantation. Without&#xD;
      imminent action, mortality from HCV-related disease is projected to triple over the next&#xD;
      decade and HCV-related deaths have already surpassed deaths related to HIV.&#xD;
&#xD;
      While past HCV therapies have been relatively ineffective, new oral treatment regimens with&#xD;
      direct-acting antivirals are substantially more efficacious, with few side effects, and cure&#xD;
      rates as high as 100% for both HCV+ and HIV/HCV+ individuals. Importantly, successful HCV&#xD;
      treatment has been associated with decreased mortality. Unfortunately, there are significant&#xD;
      gaps along the HCV care cascade that prevent patients from ever realizing the benefits of&#xD;
      these revolutionary medications. Approximately 10% of all HCV+ patients, and even fewer IDUs,&#xD;
      have ever initiated HCV treatment.&#xD;
&#xD;
      Given the ease and efficacy of the new HCV medications, investigators have an unprecedented&#xD;
      opportunity to treat IDUs within medical settings that they are already accessing, such as&#xD;
      primary care clinics. Community-based primary care clinics, such as Federally Qualified&#xD;
      Health Centers (FQHCs), are abundant throughout the US and serve populations at high risk for&#xD;
      HCV, such as IDUs; studies show an HCV prevalence rate of approximately 8% in FQHCs almost 5&#xD;
      times greater than the general population. Over the past year at Montefiore Medical Center,&#xD;
      investigators have piloted onsite HCV treatment at one FQHC and treated nearly 50 patients&#xD;
      (81% former or current IDUs) with direct-acting antivirals, with 93% cure rates.&#xD;
&#xD;
      Despite high HCV cure rates for those treated in primary care at our FQHC, only a small&#xD;
      minority of eligible patients has initiated treatment. Though onsite treatment reduces&#xD;
      obstacles related to specialty referral, patient level barriers to HCV evaluation and&#xD;
      treatment uptake still exist. IDUs in particular often have limited HCV knowledge, as well as&#xD;
      low perceived vulnerability to poor HCV-related health outcomes, low self-esteem and poor&#xD;
      self-efficacy, high levels of perceived stigma, and mistrust of healthcare providers. These,&#xD;
      as well as other barriers, prevent many IDUs from ever initiating HCV evaluation or starting&#xD;
      the treatment uptake process. Investigators therefore propose to test an HCV Group Evaluation&#xD;
      and Treatment UPtake (HCV GET-UP) intervention to improve HCV medical evaluation and&#xD;
      treatment uptake for HCV and HCV/HIV IDUs within an FQHC. Group-based interventions, often&#xD;
      familiar to IDUs, provide social support and encourage behavior change, which together&#xD;
      promote enhanced engagement in care. Group-based care can also allow efficient delivery of&#xD;
      health-education and medical treatment. Informed by the Information-Motivation-Behavior (IMB)&#xD;
      model. Investigators hypothesize that a group-based HCV intervention, HCV GET-UP, delivered&#xD;
      in an FQHC already accessed by patients, will improve HCV treatment uptake by: (1) providing&#xD;
      HCV education; (2) increasing motivation by minimizing stigma, and addressing competing&#xD;
      priorities and social norms; and (3) increasing self-efficacy and related behavioral skills.&#xD;
      Investigator propose the following specific aims:&#xD;
&#xD;
      Aim 1: To assess the feasibility and acceptability of HCV GET-UP. Investigators will pre-test&#xD;
      HCV GET-UP by conducting two group interventions (each consisting of 4 weekly sessions; 8&#xD;
      participants in each intervention group). Investigators will assess feasibility by examining&#xD;
      process measures, and acceptability using a brief, self-administered questionnaire after each&#xD;
      of the 4 sessions. Investigators will also conduct focus groups after the entire 4-session&#xD;
      intervention. Investigators will then refine HCV GET-UP based on these findings.&#xD;
&#xD;
      Aim 2: To conduct a pilot randomized controlled trial of the efficacy of HCV GET-UP for&#xD;
      improving HCV treatment uptake in an FQHC. Investigators will enroll 96 HCV+ or HIV/HCV+ IDUs&#xD;
      and randomize them 1:1 to HCV GET-UP plus onsite treatment in primary care (intervention)&#xD;
      versus onsite treatment alone (control). Our primary outcome is HCV treatment uptake, and&#xD;
      secondary outcomes will include HCV medical evaluation, HCV treatment completion, and HCV&#xD;
      cure.&#xD;
&#xD;
      Aim 3: To determine potential moderators and mediators of the impact of HCV GET-UP on HCV&#xD;
      treatment uptake, using a sequential explanatory design. First, Investigators will perform&#xD;
      exploratory quantitative analyses to determine if there are specific patient characteristics&#xD;
      (demographic, clinical) that moderate the intervention effect, and if there are mediators&#xD;
      (reduced stigma, peer support, increased self-efficacy) of HCV GET-UP's impact on treatment&#xD;
      uptake. Second, investigators will perform semi-structured interviews with 20 participants&#xD;
      randomized to HCV-GET UP to explore potential moderators/mediators deduced from quantitative&#xD;
      analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Random Controlled Trials (RCT)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hepatitis C Virus (HCV) Treatment Uptake</measure>
    <time_frame>within 6 months after HCV medical Evaluation Visit</time_frame>
    <description>First HCV medication prescription filled</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hepatitis C Virus (HCV) medical evaluation</measure>
    <time_frame>within 6 months after Baseline Research visit</time_frame>
    <description>Sustained Virological Response at 12 weeks post-treatment (SVR12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatitis C Virus (HCV) treatment completion</measure>
    <time_frame>8 or 12 weeks depending on medication</time_frame>
    <description>Completion will be tracked via pharmacy records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatitis C Virus (HCV) cure</measure>
    <time_frame>12 weeks after treatment completion</time_frame>
    <description>Sustained Undetectable HCV Viral Load at least 12 weeks post-treatment (SVR12)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Hepatitis C</condition>
  <condition>Substance Use Disorders</condition>
  <arm_group>
    <arm_group_label>HCV GET-UP (Group Intervention)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HCV GET-Up (Group Evaluation and Treatment Uptake)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individual onsite HCV treatment at a primary care center</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HCV GET-Up (Group Evaluation and Treatment Uptake)</intervention_name>
    <description>Groups will meet for 4 weekly 1-hour sessions facilitated by the PI and focused on providing education, motivation, and behavior change skills, along with an HCV medical evaluation. Patients will then be offered HCV treatment by individual provider after 4-week group evaluation and education intervention.</description>
    <arm_group_label>HCV GET-UP (Group Intervention)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HCV Ab+ with detectable HCV viral load&#xD;
&#xD;
          -  greater than fifth grade reading level&#xD;
&#xD;
          -  English proficiency&#xD;
&#xD;
          -  current or former IDUs&#xD;
&#xD;
          -  willingness to be randomized to a group intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  short life-expectancy, such that HCV treatment would not be beneficial (e.g. end-stage&#xD;
             cancer)&#xD;
&#xD;
          -  decompensated liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brianna L Norton, DO, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center/Albert Einstein College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Health Care Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03242655
org study id: 2016-6948
secondary id: K23DA039060-03PD
nct id: NCT03242655
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
People who inject drugs (PWID) represent the overwhelming majority of both HCV and HIV/HCV
      infected people in the United States. Though new, direct-acting HCV medications are highly
      efficacious and have the potential to end the HCV epidemic, few PWIDs ever initiate
      treatment. This study seeks to improve HCV treatment uptake and cure among HCV and HIV/HCV+
      PWIDs by testing a primary care based HCV Group Evaluation and Treatment UPtake (GET-UP)
      intervention. If efficacious, this innovative care intervention could provide a means to
      reduce the growing mortality from HCV, as well as decrease the current reservoir for HCV
      transmission.
The goal of this proposal is to improve HCV (hepatitis C virus) treatment uptake among
      current and former injection drug users (IDUs) by testing an innovative, primary care based
      HCV Group Evaluation and Treatment UPtake (HCV GET-UP) intervention. IDUs make up the
      majority of the 4 million Americans chronically infected with HCV, and up to 90% of HIV+ IDUs
      are infected with HCV. In the U.S., HCV is the leading cause of end-stage liver disease and
      hepatocellular carcinoma, and the most common indication for liver transplantation. Without
      imminent action, mortality from HCV-related disease is projected to triple over the next
      decade and HCV-related deaths have already surpassed deaths related to HIV.

      While past HCV therapies have been relatively ineffective, new oral treatment regimens with
      direct-acting antivirals are substantially more efficacious, with few side effects, and cure
      rates as high as 100% for both HCV+ and HIV/HCV+ individuals. Importantly, successful HCV
      treatment has been associated with decreased mortality. Unfortunately, there are significant
      gaps along the HCV care cascade that prevent patients from ever realizing the benefits of
      these revolutionary medications. Approximately 10% of all HCV+ patients, and even fewer IDUs,
      have ever initiated HCV treatment.

      Given the ease and efficacy of the new HCV medications, investigators have an unprecedented
      opportunity to treat IDUs within medical settings that they are already accessing, such as
      primary care clinics. Community-based primary care clinics, such as Federally Qualified
      Health Centers (FQHCs), are abundant throughout the US and serve populations at high risk for
      HCV, such as IDUs; studies show an HCV prevalence rate of approximately 8% in FQHCs almost 5
      times greater than the general population. Over the past year at Montefiore Medical Center,
      investigators have piloted onsite HCV treatment at one FQHC and treated nearly 50 patients
      (81% former or current IDUs) with direct-acting antivirals, with 93% cure rates.

      Despite high HCV cure rates for those treated in primary care at our FQHC, only a small
      minority of eligible patients has initiated treatment. Though onsite treatment reduces
      obstacles related to specialty referral, patient level barriers to HCV evaluation and
      treatment uptake still exist. IDUs in particular often have limited HCV knowledge, as well as
      low perceived vulnerability to poor HCV-related health outcomes, low self-esteem and poor
      self-efficacy, high levels of perceived stigma, and mistrust of healthcare providers. These,
      as well as other barriers, prevent many IDUs from ever initiating HCV evaluation or starting
      the treatment uptake process. Investigators therefore propose to test an HCV Group Evaluation
      and Treatment UPtake (HCV GET-UP) intervention to improve HCV medical evaluation and
      treatment uptake for HCV and HCV/HIV IDUs within an FQHC. Group-based interventions, often
      familiar to IDUs, provide social support and encourage behavior change, which together
      promote enhanced engagement in care. Group-based care can also allow efficient delivery of
      health-education and medical treatment. Informed by the Information-Motivation-Behavior (IMB)
      model. Investigators hypothesize that a group-based HCV intervention, HCV GET-UP, delivered
      in an FQHC already accessed by patients, will improve HCV treatment uptake by: (1) providing
      HCV education; (2) increasing motivation by minimizing stigma, and addressing competing
      priorities and social norms; and (3) increasing self-efficacy and related behavioral skills.
      Investigator propose the following specific aims:

      Aim 1: To assess the feasibility and acceptability of HCV GET-UP. Investigators will pre-test
      HCV GET-UP by conducting two group interventions (each consisting of 4 weekly sessions; 8
      participants in each intervention group). Investigators will assess feasibility by examining
      process measures, and acceptability using a brief, self-administered questionnaire after each
      of the 4 sessions. Investigators will also conduct focus groups after the entire 4-session
      intervention. Investigators will then refine HCV GET-UP based on these findings.

      Aim 2: To conduct a pilot randomized controlled trial of the efficacy of HCV GET-UP for
      improving HCV treatment uptake in an FQHC. Investigators will enroll 96 HCV+ or HIV/HCV+ IDUs
      and randomize them 1:1 to HCV GET-UP plus onsite treatment in primary care (intervention)
      versus onsite treatment alone (control). Our primary outcome is HCV treatment uptake, and
      secondary outcomes will include HCV medical evaluation, HCV treatment completion, and HCV
      cure.

      Aim 3: To determine potential moderators and mediators of the impact of HCV GET-UP on HCV
      treatment uptake, using a sequential explanatory design. First, Investigators will perform
      exploratory quantitative analyses to determine if there are specific patient characteristics
      (demographic, clinical) that moderate the intervention effect, and if there are mediators
      (reduced stigma, peer support, increased self-efficacy) of HCV GET-UP's impact on treatment
      uptake. Second, investigators will perform semi-structured interviews with 20 participants
      randomized to HCV-GET UP to explore potential moderators/mediators deduced from quantitative
      analyses.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Random Controlled Trials (RCT)
primary purpose: Treatment
masking: None (Open Label)
measure: Hepatitis C Virus (HCV) Treatment Uptake
time frame: within 6 months after HCV medical Evaluation Visit
description: First HCV medication prescription filled
measure: Hepatitis C Virus (HCV) medical evaluation
time frame: within 6 months after Baseline Research visit
description: Sustained Virological Response at 12 weeks post-treatment (SVR12)
measure: Hepatitis C Virus (HCV) treatment completion
time frame: 8 or 12 weeks depending on medication
description: Completion will be tracked via pharmacy records
measure: Hepatitis C Virus (HCV) cure
time frame: 12 weeks after treatment completion
description: Sustained Undetectable HCV Viral Load at least 12 weeks post-treatment (SVR12)
arm group label: HCV GET-UP (Group Intervention)
arm group type: Experimental
description: HCV GET-Up (Group Evaluation and Treatment Uptake)
arm group label: Control
arm group type: No Intervention
description: Individual onsite HCV treatment at a primary care center
intervention type: Behavioral
intervention name: HCV GET-Up (Group Evaluation and Treatment Uptake)
description: Groups will meet for 4 weekly 1-hour sessions facilitated by the PI and focused on providing education, motivation, and behavior change skills, along with an HCV medical evaluation. Patients will then be offered HCV treatment by individual provider after 4-week group evaluation and education intervention.
arm group label: HCV GET-UP (Group Intervention)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Brianna L Norton, DO, MPH
role: Principal Investigator
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Substance-Related Disorders
sharing ipd: No