Hepatitis C ChronicNCT06373198
Implementation of a Re-engagement Program for Hepatitis C Patients Lost to Follow-up in Argentina.
An observational study of Hepatitis C Chronic and Hepatitis C, run by Hospital El Cruce.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Chronic, Hepatitis C
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 15 Jan 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCV viremic patients treatment naive or experienced
Who may be able to join
- All of the following inclusion criteria must be met.
- Over 18 years old
- Diagnosis of chronic HCV
Who cannot join
- no
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Hepatitis C Chronic, Hepatitis C
- Being tested
- standard of care
- Keywords
- viral hepatitis, treatment, direct antivirals agents, relink, linkage to care
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From Mayo 2024 to January 2025
Secondary outcomes (1)
Evaluation and characteristics of the treatment established
- 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
Measured: From Mayo 2024 to January 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital El Cruce
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Fernando Mario Cairo, Hospital El Cruce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373198
- Sponsor's protocol ID
- 0040/2023-versión 1.0
- Status last verified
- Apr 2024
- First submitted
- 22 Feb 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data underpinning the reported study results, including data used in analyses for text, tables, figures, and appendices, will be shared.
Publications
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.
PubMed 18064739Mendizabal 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.
PubMed 36197907Wansom 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.
PubMed 28480293Lazarus 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.
PubMed 28760329Mendizabal 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.
PubMed 31288259Yehia 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.
PubMed 24988388
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Re-engagement Program for Hepatitis C Patients Lost to Follow-up in Argentina.
- ClinicalTrials.gov ID
- NCT06373198
- Acronym / sponsor ID
- 0040/2023-versión 1.0
- Conditions
- Hepatitis C Chronic, Hepatitis C
- Keywords
- viral hepatitis, treatment, direct antivirals agents, relink, linkage to care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Hospital El CruceUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| i. Strategy to re-engage HCV patients in a high complex hospital with a network | – | Other: standard of careAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCV viremic patients treatment naive or experienced
Key inclusion criteria (3 listed)
- All of the following inclusion criteria must be met.
- Over 18 years old
- Diagnosis of chronic HCV
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard of careAn 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 | i. Strategy to re-engage HCV patients in a high complex hospital with a network |
Primary outcome
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.
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.
1 secondary outcome
Evaluation and characteristics of the treatment established
Time frame: From Mayo 2024 to January 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Results publication: PubMed 18064739von 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.
- Results publication: PubMed 36197907Mendizabal 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.
- Results publication: PubMed 28480293Wansom 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.
- Results publication: PubMed 28760329Lazarus 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.
- Results publication: PubMed 31288259Mendizabal 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.
- Results publication: PubMed 24988388Yehia 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.
- Designing clinical reserchLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified participant data underpinning the reported study results, including data used in analyses for text, tables, figures, and appendices, will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Chronic and Hepatitis C, run by Hospital El Cruce.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando m Cairo, MD (+544210-9000 ext. 2812, jefatura.TOS@hospitalelcruce.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of relinked HCV patients (time frame: From Mayo 2024 to January 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06373198, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.