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Re-linkage to Care of Patients With Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04470271
Recruitment Status : Not yet recruiting
First Posted : July 14, 2020
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Julia Cremona, Austral University, Argentina

Brief Summary:
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

Condition or disease Intervention/treatment
Viral Hepatitis C Other: Patients with hepatitis C lost follow up

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 6 Months
Official Title: Effectiveness of Implementing a Strategy to Re-linkage to Care of Patients With Hepatitis C Who Were Lost to Follow-up
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients under routine hepatitis C care
Patients who are routinely followed at the treating institution. Investigators will evaluate baseline demographic, liver fibrosis stage, liver-related complications, and antiviral therapy.
Patients with hepatitis C lost of follow-up
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.
Other: Patients with hepatitis C lost follow up
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




Primary Outcome Measures :
  1. Number of participants who were lost of follow up [ Time Frame: through study completion, an average of 6 months ]
    Participants are going to be contacted by phone or email to evaluate if they are under HCV care



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with history of chronic HCV infection who were lost of follow up.
Criteria

Inclusion Criteria:

  • Patients older than 18 years
  • Patients clinically evaluated at least once in the participating medical center
  • chronic HCV infection

Exclusion Criteria:

  • There are no exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470271


Contacts
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Contact: Manuel Mendizabal, MD +5491140332244 mmendiza@cas.austral.edu.ar

Locations
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Argentina
Universidad Austral
Pilar, Buenos Aires, Argentina, 1629
Sponsors and Collaborators
Austral University, Argentina
Investigators
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Principal Investigator: Marcelo O Silva, MD Austral University, Argentina
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Responsible Party: Maria Julia Cremona, Coordinator, Austral University, Argentina
ClinicalTrials.gov Identifier: NCT04470271    
Other Study ID Numbers: CIE N° P 20-008
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Julia Cremona, Austral University, Argentina:
viral infection
outcome
antiviral therapy
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections