Implementation of a Re-engagement Program for Hepatitis C Patients Lost to Follow-up in Argentina.

April 17, 2024 updated by: Fernando Mario Cairo, Hospital El Cruce

Hepatitis C virus (HCV) is a leading cause of morbidity and mortality worldwide. This infection continues to represent a major global public health concern. This is why the introduction of potent antivirals for the treatment of HCV has been one of the major breakthroughs of the current medical era.

From a public health perspective, HCV prevalence will be eliminated if the available treatment also targets those most likely to transmit the virus. Despite this scientific advance, a systematic review from the U.S. described that of the 43% of patients aware of their HCV diagnosis, only 16% started treatment. Clearly, the long-known barriers to accessing this treatment must be broken down in order to administer these effective antivirals. The World Health Organization (WHO) has set the ambitious goal of eliminating viral hepatitis as a public health threat by 2030. This goal is really difficult to achieve, especially in low and middle-income countries. Particularly in Argentina, there is a need to improve diagnosis, access to care, and treatment of viral hepatitis. The prospect of viral hepatitis elimination in our country is daunting due to the complexity of the health system and the cost of implementing different strategies. The most pragmatic approach would be to break down national elimination targets into smaller targets for individual populations, for which treatment and prevention interventions can be delivered more quickly and efficiently. This concept is known as micro-elimination. Focusing on micro-elimination of viral hepatitis means working to achieve the WHO target in specific subpopulations. Subpopulations known to have a higher prevalence of HCV infection include prisoners, people who inject drugs, and patients requiring hemodialysis, among others.

Currently, patient unawareness of HCV infection represents one of the major barriers to treatment. In many cases, the diagnosis of HCV was established many years ago and patients do not seek treatment probably because they do not recognize the urgency of treating this asymptomatic infection. It is our goal, then, to identify the group of individuals who have been diagnosed with HCV infection but are not currently undergoing regular visits with health care professionals. This strategy is now called re-linking to the medical care of patients with chronic HCV.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The protocol consists of implementing a strategy to contact patients with HCV who have been lost to follow-up. Establish a single model of confidential information management.

Population. From a cohort of patients, a non-probabilistic sampling of subjects meeting the eligibility criteria will be performed

Study Variables - Demographic data: age, gender

HCV-related data:

  • Hepatic complications such as hepatocarcinoma, ascites, encephalopathy, variceal hemorrhage and liver transplantation.
  • Extrahepatic manifestations such as non-Hodgkin's lymphoma, cryoglobulinemia, porphyria cutanea tarda, cardiovascular disease, diabetes mellitus.
  • Previous antiviral treatment with interferon-based or direct antiviral drugs.

Sources of information

  • Patient contact: phone call and/or e-mail.
  • Review of electronic medical records.

Patient contact strategy:

- Patients identified as lost to follow-up will be contacted by telephone. Initially 3 calls will be made from Monday to Friday. If the patient is not located, he/she will be called on a Saturday and an e-mail will be sent (if available).

Possible outcomes after the intervention:

  • Not contacted despite implemented strategy
  • Death
  • Treated at another center
  • Contacted and candidate for follow-up

Measurement and data logging:

A specific form will be used to record the data, which will later be entered into a computerized database for subsequent analysis of the information. The research physicians who will be blinded will collect the exposure variables included in the survey to the results. Data for each patient will be obtained from the computerized medical record. Those patients with chronic HCV and whose disease course is unknown will be contacted by telephone to evaluate the status of their disease and to offer them, eventually, medical follow-up in our institution.

Ethics and Good Clinical Practices. The study protocol has been developed according to national standards for ethical, legal and juridical requirements, established in the Ministerial Resolution 1480/11 and international standards according to STROBE guidelines and according to ethical criteria of the Helsinki Declaration 2013, Nuremberg Code, Universal Declaration on Human Genome and Human Rights approved by the UNESCO General Conference 1997. As well as according to GCP standards (Good Clinical Practice). The confidentiality of all the data of each individual will be strictly maintained by means of the following strategies: the enrollment of the name, full ID and date of birth will be avoided, and will be replaced by coded data for the identification of the consequent methodologies according to this protocol.

Schedule of activities

  • Medical records review phase: 6 months
  • Phase of telephone calls: 3 months
  • Results evaluation phase 3 months: end of the study and final variable measurements.

Expected results Describing, knowing, understanding the impact of the disease we expect to find a significant number of patients with chronic HCV who are lost to follow-up. Likewise, some of these patients will likely be in follow-up at other institutions.

Study Type

Observational

Enrollment (Estimated)

800

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 Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

HCV viremic patients treatment naive or experienced

Description

Inclusion Criteria:

  • All of the following inclusion criteria must be met.
  • Over 18 years old
  • Diagnosis of chronic HCV

Exclusion Criteria:

  • no

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
i. Strategy to re-engage HCV patients in a high complex hospital with a network
An evaluation of the positivity of the hepatitis C test will be carried out. Positive patients will be included in the follow-up and specific treatment will be requested to achieve a cure. Standard of care will be applied.
Other: standard of care
An evaluation of the positivity of the hepatitis C test will be carried out. Positive patients will be included in the follow-up and specific treatment will be requested to achieve a cure. Standard of care will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of relinked HCV patients
Time Frame: From Mayo 2024 to January 2025
Strategy to re-engage HCV patients in a high complex hospital with a network of medium and low complexity hospitals.
From Mayo 2024 to January 2025
proportion of relinked patients who received antiviral treatment
Time Frame: From Mayo 2024 to January 2025
Strategy to re-engage HCV patients in a high complex hospital with a network of medium and low complexity hospitals.
From Mayo 2024 to January 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation and characteristics of the treatment established
Time Frame: From Mayo 2024 to January 2025
  • Describe the evolution of patients with HCV under follow-up.
  • describe the evolution and characteristics of HCV patients lost to follow-up.
  • Evaluate the number of patients relinked who effectively start treatment
  • Evaluate sustained virologic response rates and long-term clinical outcomes in patients who initiate treatment.
  • To evaluate SVR 4
From Mayo 2024 to January 2025

Collaborators and Investigators

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

Sponsor

Hospital El Cruce

Collaborators

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

May 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0040/2023-versión 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data underpinning the reported study results, including data used in analyses for text, tables, figures, and appendices, will be shared.

IPD Sharing Time Frame

January 2025-January 2026

IPD Sharing Access Criteria

Permission from the principal investigator is requested via email.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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