Implementation of a Re-engagement Program for Hepatitis C Patients Lost to Follow-up in Argentina.
1 other identifier
observational
800
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2024
CompletedFirst Posted
Study publicly available on registry
April 18, 2024
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2025
CompletedApril 18, 2024
April 1, 2024
2 months
February 22, 2024
April 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
rate of relinked HCV patients
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
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 Outcomes (1)
Evaluation and characteristics of the treatment established
From Mayo 2024 to January 2025
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
HCV viremic patients treatment naive or experienced
You may qualify if:
- Over 18 years old
- Diagnosis of chronic HCV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital El Crucelead
- Gilead Sciencescollaborator
Related Publications (6)
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
PMID: 18064739RESULTMendizabal M, Thompson M, Gonzalez-Ballerga E, Anders M, Castro-Narro GE, Pessoa MG, Cheinquer H, Mezzano G, Palazzo A, Ridruejo E, Descalzi V, Velarde-Ruiz Velasco JA, Marciano S, Munoz L, Schinoni MI, Poniachik J, Perazzo R, Cerda E, Fuster F, Varon A, Ruiz Garcia S, Soza A, Cabrera C, Gomez-Aldana AJ, Beltran FM, Gerona S, Cocozzella D, Bessone F, Hernandez N, Alonso C, Ferreiro M, Antinucci F, Torre A, Moutinho BD, Coelho Borges S, Gomez F, Murga MD, Pinero F, Sotera GF, Ocampo JA, Cortes Mollinedo VA, Simian D, Silva MO. Implementation of a re-linkage to care strategy in patients with chronic hepatitis C who were lost to follow-up in Latin America. J Viral Hepat. 2023 Jan;30(1):56-63. doi: 10.1111/jvh.13758. Epub 2022 Oct 17.
PMID: 36197907RESULTWansom T, Falade-Nwulia O, Sutcliffe CG, Mehta SH, Moore RD, Thomas DL, Sulkowski MS. Barriers to Hepatitis C Virus (HCV) Treatment Initiation in Patients With Human Immunodeficiency Virus/HCV Coinfection: Lessons From the Interferon Era. Open Forum Infect Dis. 2017 Feb 11;4(1):ofx024. doi: 10.1093/ofid/ofx024. eCollection 2017 Winter.
PMID: 28480293RESULTLazarus JV, Wiktor S, Colombo M, Thursz M; EASL International Liver Foundation. Micro-elimination - A path to global elimination of hepatitis C. J Hepatol. 2017 Oct;67(4):665-666. doi: 10.1016/j.jhep.2017.06.033. Epub 2017 Jul 29. No abstract available.
PMID: 28760329RESULTMendizabal M, Alonso C, Silva MO. Overcoming barriers to hepatitis C elimination. Frontline Gastroenterol. 2019 Jul;10(3):207-209. doi: 10.1136/flgastro-2018-101114. Epub 2019 Feb 1. No abstract available.
PMID: 31288259RESULTYehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014 Jul 2;9(7):e101554. doi: 10.1371/journal.pone.0101554. eCollection 2014.
PMID: 24988388RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 22, 2024
First Posted
April 18, 2024
Study Start
May 1, 2024
Primary Completion
July 1, 2024
Study Completion
January 15, 2025
Last Updated
April 18, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- January 2025-January 2026
- Access Criteria
- Permission from the principal investigator is requested via email.
De-identified participant data underpinning the reported study results, including data used in analyses for text, tables, figures, and appendices, will be shared.