<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/NCT04470271</url>
  </required_header>
  <id_info>
    <org_study_id>CIE N° P 20-008</org_study_id>
    <nct_id>NCT04470271</nct_id>
  </id_info>
  <brief_title>Re-linkage to Care of Patients With Hepatitis C</brief_title>
  <official_title>Effectiveness of Implementing a Strategy to Re-linkage to Care of Patients With Hepatitis C Who Were Lost to Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Austral University, Argentina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Austral University, Argentina</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>
      The purpose of this study is to identify patients with chronic hepatitis C virus (HCV) who&#xD;
      were lost of follow up and relinkage them to hepatitis C care&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will review electronic medical charts to identify patients with HCV&#xD;
      diagnosis. Next, investigators will evaluate if these patients are routinely followed by&#xD;
      liver specialists at the Institution. Those patients who were lost of follow up will be&#xD;
      reached to evaluate their disease and eventually offer them to restart HCV care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Number of participants who were lost of follow up</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Participants are going to be contacted by phone or email to evaluate if they are under HCV care</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Viral Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Patients under routine hepatitis C care</arm_group_label>
    <description>Patients who are routinely followed at the treating institution. Investigators will evaluate baseline demographic, liver fibrosis stage, liver-related complications, and antiviral therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with hepatitis C lost of follow-up</arm_group_label>
    <description>Patients who were lost of follow-up. Participants will be contacted to evaluate if the continued HCV care at another institution, were not routinely followed by a liver-specialist or if they died. Investigators will also evaluate baseline demographic, liver fibrosis stage, liver-related complications, and antiviral therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patients with hepatitis C lost follow up</intervention_name>
    <description>Patients with chronic HCV who were lost of follow up will be contacted by phone or email. At least 3 phone calls will be made on three different days. In case the patient is not contacted it will be considered lost of follow-up</description>
    <arm_group_label>Patients with hepatitis C lost of follow-up</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with history of chronic HCV infection who were lost of follow up.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years&#xD;
&#xD;
          -  Patients clinically evaluated at least once in the participating medical center&#xD;
&#xD;
          -  chronic HCV infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Marcelo O Silva, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Austral University, Argentina</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Manuel Mendizabal, MD</last_name>
    <phone>+5491140332244</phone>
    <email>mmendiza@cas.austral.edu.ar</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universidad Austral</name>
      <address>
        <city>Pilar</city>
        <state>Buenos Aires</state>
        <zip>1629</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Austral University, Argentina</investigator_affiliation>
    <investigator_full_name>Maria Julia Cremona</investigator_full_name>
    <investigator_title>Coordinator</investigator_title>
  </responsible_party>
  <keyword>viral infection</keyword>
  <keyword>outcome</keyword>
  <keyword>antiviral therapy</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</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/NCT04470271
org study id: CIE N° P 20-008
nct id: NCT04470271
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to identify patients with chronic hepatitis C virus (HCV) who
      were lost of follow up and relinkage them to hepatitis C care
The investigators will review electronic medical charts to identify patients with HCV
      diagnosis. Next, investigators will evaluate if these patients are routinely followed by
      liver specialists at the Institution. Those patients who were lost of follow up will be
      reached to evaluate their disease and eventually offer them to restart HCV care.
observational model: Cohort
time perspective: Cross-Sectional
measure: Number of participants who were lost of follow up
time frame: through study completion, an average of 6 months
description: Participants are going to be contacted by phone or email to evaluate if they are under HCV care
arm group label: Patients under routine hepatitis C care
description: Patients who are routinely followed at the treating institution. Investigators will evaluate baseline demographic, liver fibrosis stage, liver-related complications, and antiviral therapy.
arm group label: Patients with hepatitis C lost of follow-up
description: Patients who were lost of follow-up. Participants will be contacted to evaluate if the continued HCV care at another institution, were not routinely followed by a liver-specialist or if they died. Investigators will also evaluate baseline demographic, liver fibrosis stage, liver-related complications, and antiviral therapy.
intervention type: Other
intervention name: Patients with hepatitis C lost follow up
description: Patients with chronic HCV who were lost of follow up will be contacted by phone or email. At least 3 phone calls will be made on three different days. In case the patient is not contacted it will be considered lost of follow-up
arm group label: Patients with hepatitis C lost of follow-up
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Marcelo O Silva, MD
role: Principal Investigator
affiliation: Austral University, Argentina
last name: Manuel Mendizabal, MD
phone: +5491140332244
email: mmendiza@cas.austral.edu.ar
facility: 
country: Argentina
responsible party type: Principal Investigator
investigator affiliation: Austral University, Argentina
investigator full name: Maria Julia Cremona
investigator title: Coordinator
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
sharing ipd: No