<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/NCT04499651</url>
  </required_header>
  <id_info>
    <org_study_id>ISR-US-18-10586</org_study_id>
    <nct_id>NCT04499651</nct_id>
  </id_info>
  <brief_title>Testing of a Navigation Intervention for Hepatitis C and HIV</brief_title>
  <acronym>LINKHCV</acronym>
  <official_title>Adaptation and Testing of a Navigation Intervention for Hepatitis C and HIV Co-infected Persons Leaving LA County Jail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</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>
      This study will evaluate the efficacy of navigation for hepatitis C treatment in people&#xD;
      living with both HIV and HCV with criminal justice involvement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatitis C (HCV) is the most common chronic, blood-borne infection in the U.S. and,&#xD;
      untreated, can result in liver failure and liver cancer. Despite advances in treatment and&#xD;
      remarkable improvements in cure rates, very few persons with chronic HCV infection are&#xD;
      receiving this treatment, especially among people who use drugs, who are also&#xD;
      disproportionately HIV-infected and incarcerated. Existing efforts to ensure linkage to and&#xD;
      retention in medical care following release from incarceration among people living with both&#xD;
      HIV and HCV are generally insufficient. Increasing treatment engagement following release&#xD;
      from incarceration can drastically reduce HCV and HIV in the blood, which can limit&#xD;
      transmission to sexual and injection drug use partners.&#xD;
&#xD;
      The goal of this study is to evaluate the effect of a novel navigation intervention to&#xD;
      improve HIV/HCV treatment engagement among HIV/HCV co-infected adults with criminal justice&#xD;
      involvement. The investigators hypothesize that the navigation intervention is more effective&#xD;
      than the current standard-of-care approaches to link this population of adults to HIV/HCV&#xD;
      treatment. All participants, regardless of study arm, will complete one baseline interview&#xD;
      around the time of study enrollment. Follow-up interviews are done at 3 months and 8 months&#xD;
      following enrollment (if enrolled in the community) or after release from jail (if enrolled&#xD;
      in the jail).&#xD;
&#xD;
      Blood samples to analyze the HCV RNA will be collected or requested from participants'&#xD;
      clinics both for the baseline assessment and the assessment conducted 12 weeks after&#xD;
      completion of the HCV treatment course (if the HCV RNA result cannot be obtained at 12 weeks,&#xD;
      it will done at the 8-month follow-up interview). HIV RNA will be collected from the clinics.&#xD;
&#xD;
      In addition to the interviews and the HCV/HIV RNA assessments, participants assigned to the&#xD;
      intervention arm will engage in a six- or seven-session navigation intervention. Participants&#xD;
      will be in the study for about 12 months but no more than 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient enrollment numbers due to Covid-19 pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Actual">February 22, 2021</completion_date>
  <primary_completion_date type="Actual">February 22, 2021</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Undetectable Hepatitis C RNA</measure>
    <time_frame>8 months</time_frame>
    <description>Undetectable Hepatitis C RNA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Undetectable HIV RNA</measure>
    <time_frame>8 months</time_frame>
    <description>HIV RNA &lt;40 copies/ml</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>HIV (Human Immunodeficiency Virus)</condition>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All people who are living with HIV who are currently in custody in the Los Angeles County Jail are provided with Transitional Case Management and may also receive Whole Person Care related services regardless of participation in this study. Participants recruited from clinics who do not enroll in the study will be offered HIV/HCV care that follows the national HIV/HCV care guidelines, as provided by participating study clinics. Participants recruited from non-medical community agencies who do not enroll in the study and do not have a regular provider will receive a referral list of HIV/HCV care facilities that follow the national HIV/HCV care guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Navigation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be paired with a navigator and will complete the following didactic sessions in one-on-one format:&#xD;
Session 1: Intervention Overview and Basic HIV/HCV Knowledge and Skills Builder&#xD;
Session 2: Rapport Building&#xD;
Session 3: Society and Self and the Role of Disclosure&#xD;
Session 4: Accompaniment 1&#xD;
Session 5: Goal-Setting, Problem-Solving and a Disclosure Toolkit&#xD;
Session 6: Accompaniment 2&#xD;
Session 7: Accompaniment 3 (ONLY if needed)&#xD;
Weekly check-in calls following Session 2 for six months</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Navigation</intervention_name>
    <description>Trained study navigators will provide one-on-one learning sessions and accompaniments to criminal-justice involved people to help link them to HIV/Hepatitis C care</description>
    <arm_group_label>Navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (if recruited in jail)&#xD;
&#xD;
          1. Diagnosed HIV+/HCV co-infection;&#xD;
&#xD;
          2. 18 years of age or older;&#xD;
&#xD;
          3. non-cis women;&#xD;
&#xD;
          4. Fluent in speaking English;&#xD;
&#xD;
          5. Have an anticipated sentence of no more than 12 months;&#xD;
&#xD;
          6. Have detectable Hepatitis C viral load&#xD;
&#xD;
          7. Going to live in LA County, Kern County, San Diego County, Riverside County, Ventura&#xD;
             County or San Bernardino County&#xD;
&#xD;
        If recruited outside of jail:&#xD;
&#xD;
          1. Diagnosed HIV+/HCV co-infection;&#xD;
&#xD;
          2. 18 years of age or older;&#xD;
&#xD;
          3. non-cis women;&#xD;
&#xD;
          4. Fluent in speaking English;&#xD;
&#xD;
          5. Incarceration history within the last 12 months of enrollment;&#xD;
&#xD;
          6. Have detectable Hepatitis C viral load&#xD;
&#xD;
          7. Going to live in LA County, Kern County, San Diego County, Riverside County, Ventura&#xD;
             County or San Bernardino County&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to give informed consent&#xD;
&#xD;
          2. CD4 count&lt;200&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>All cis-men (assigned &quot;male&quot; at birth) are eligible for the study regardless of current gender identification.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Goodman-Meza, MD, MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Debika Bhattacharya, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>David Goodman-Meza, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Corrections</keyword>
  <keyword>Engagement-in-care</keyword>
  <keyword>Navigation</keyword>
  <keyword>Criminal justice system</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>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Hepatitis</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/NCT04499651
org study id: ISR-US-18-10586
nct id: NCT04499651
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the efficacy of navigation for hepatitis C treatment in people
      living with both HIV and HCV with criminal justice involvement.
Hepatitis C (HCV) is the most common chronic, blood-borne infection in the U.S. and,
      untreated, can result in liver failure and liver cancer. Despite advances in treatment and
      remarkable improvements in cure rates, very few persons with chronic HCV infection are
      receiving this treatment, especially among people who use drugs, who are also
      disproportionately HIV-infected and incarcerated. Existing efforts to ensure linkage to and
      retention in medical care following release from incarceration among people living with both
      HIV and HCV are generally insufficient. Increasing treatment engagement following release
      from incarceration can drastically reduce HCV and HIV in the blood, which can limit
      transmission to sexual and injection drug use partners.

      The goal of this study is to evaluate the effect of a novel navigation intervention to
      improve HIV/HCV treatment engagement among HIV/HCV co-infected adults with criminal justice
      involvement. The investigators hypothesize that the navigation intervention is more effective
      than the current standard-of-care approaches to link this population of adults to HIV/HCV
      treatment. All participants, regardless of study arm, will complete one baseline interview
      around the time of study enrollment. Follow-up interviews are done at 3 months and 8 months
      following enrollment (if enrolled in the community) or after release from jail (if enrolled
      in the jail).

      Blood samples to analyze the HCV RNA will be collected or requested from participants'
      clinics both for the baseline assessment and the assessment conducted 12 weeks after
      completion of the HCV treatment course (if the HCV RNA result cannot be obtained at 12 weeks,
      it will done at the 8-month follow-up interview). HIV RNA will be collected from the clinics.

      In addition to the interviews and the HCV/HIV RNA assessments, participants assigned to the
      intervention arm will engage in a six- or seven-session navigation intervention. Participants
      will be in the study for about 12 months but no more than 3 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Undetectable Hepatitis C RNA
time frame: 8 months
description: Undetectable Hepatitis C RNA
measure: Undetectable HIV RNA
time frame: 8 months
description: HIV RNA <40 copies/ml
arm group label: Control
arm group type: No Intervention
description: All people who are living with HIV who are currently in custody in the Los Angeles County Jail are provided with Transitional Case Management and may also receive Whole Person Care related services regardless of participation in this study. Participants recruited from clinics who do not enroll in the study will be offered HIV/HCV care that follows the national HIV/HCV care guidelines, as provided by participating study clinics. Participants recruited from non-medical community agencies who do not enroll in the study and do not have a regular provider will receive a referral list of HIV/HCV care facilities that follow the national HIV/HCV care guidelines.
arm group label: Navigation
arm group type: Active Comparator
description: Participants will be paired with a navigator and will complete the following didactic sessions in one-on-one format:
Session 1: Intervention Overview and Basic HIV/HCV Knowledge and Skills Builder
Session 2: Rapport Building
Session 3: Society and Self and the Role of Disclosure
Session 4: Accompaniment 1
Session 5: Goal-Setting, Problem-Solving and a Disclosure Toolkit
Session 6: Accompaniment 2
Session 7: Accompaniment 3 (ONLY if needed)
Weekly check-in calls following Session 2 for six months
intervention type: Behavioral
intervention name: Navigation
description: Trained study navigators will provide one-on-one learning sessions and accompaniments to criminal-justice involved people to help link them to HIV/Hepatitis C care
arm group label: Navigation
criteria: 
gender: Male
gender based: Yes
gender description: All cis-men (assigned "male" at birth) are eligible for the study regardless of current gender identification.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Goodman-Meza, MD, MAS
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Debika Bhattacharya, MD, MSc
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: David Goodman-Meza, MD
investigator title: Principal Investigator
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Hepatitis