Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373198
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-02-22
Brief Title:
Implementation of a Re-engagement Program for Hepatitis C Patients Lost to Follow-up in Argentina
Sponsor:
Hospital El Cruce
Organization:
Hospital El Cruce
Study Overview
Official Title:
Implementation of a Re-engagement Program for Hepatitis C Patients Lost to Follow-up in Argentina
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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
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 US 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
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-Hodgkin39s 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 andor 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 heshe 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 148011 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
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-Hodgkin39s 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 andor 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 heshe 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 148011 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None