Re-linkage to Care of Patients With Hepatitis C

July 10, 2020 updated by: Maria Julia Cremona, Austral University, Argentina

Effectiveness of Implementing a Strategy to Re-linkage to Care of Patients With Hepatitis C Who Were Lost to Follow-up

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, 1629
        • Universidad Austral

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austral University, Argentina

Investigators

  • Principal Investigator: Marcelo O Silva, MD, Austral University, Argentina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

March 31, 2021

Study Registration Dates

First Submitted

July 4, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIE N° P 20-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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