Viral Hepatitis CNCT04470271
Re-linkage to Care of Patients With Hepatitis C
An observational study of Viral Hepatitis C, run by Austral University, Argentina at 1 site in Argentina.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Hepatitis C
- What is being tested?
- Patients with hepatitis C lost follow up
- How many people
- 1,000 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Sep 2020to 31 Mar 2021
- How long will I take part?
- 6 Months
- 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
- Adult, Older adult
Study population: Adult patients with history of chronic HCV infection who were lost of follow up.
Who may be able to join
- Patients older than 18 years
- Patients clinically evaluated at least once in the participating medical center
- chronic HCV infection
Who cannot join
- There are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Viral Hepatitis C
- Being tested
- Patients with hepatitis C lost follow up
- Keywords
- viral infection, outcome, antiviral therapy
- Medical subject headings
- Hepatitis C, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with hepatitis C lost follow upOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patients with hepatitis C lost follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who were lost of follow up
Participants are going to be contacted by phone or email to evaluate if they are under HCV care
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Hepatitis CStudies 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Austral University, Argentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Julia Cremona, Austral University, Argentina
- Investigators
- Marcelo O Silva, MD, Principal investigator, Austral University, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470271
- Sponsor's protocol ID
- CIE N° P 20-008
- Status last verified
- Jul 2020
- First submitted
- 4 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Implementing a Strategy to Re-linkage to Care of Patients With Hepatitis C Who Were Lost to Follow-up
- ClinicalTrials.gov ID
- NCT04470271
- Acronym / sponsor ID
- CIE N° P 20-008
- Conditions
- Viral Hepatitis C
- Keywords
- viral infection, outcome, antiviral therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Austral University, ArgentinaUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 14 Jul 2020 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Patients with hepatitis C lost follow upPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with history of chronic HCV infection who were lost of follow up.
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Patients clinically evaluated at least once in the participating medical center
- chronic HCV infection
Key exclusion criteria (1 listed)
- There are no exclusion criteria
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 |
|---|---|---|
| Patients with hepatitis C lost follow upPatients 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 | Other | Patients with hepatitis C lost of follow-up |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Viral Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Marcelo O Silva, MD principal investigator
Austral University, Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Hepatitis C, run by Austral University, Argentina at 1 site in Argentina.
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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Manuel Mendizabal, MD (+5491140332244, mmendiza@cas.austral.edu.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who were lost of follow up (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2020.