Hepatitis C Virus InfectionHCVLINKAGENCT06155006
Adult Screening for Hepatitis c and Linkage to Treatment in Hospitals in Colombia
An observational study of Hepatitis C Virus Infection, run by Asociación Colombiana de Hepatología at 2 sites in Colombia.
Trial summary
Introduction: Hepatitis C virus infection is a major cause of chronic hepatitis, cirrhosis, and liver cancer. The risk of developing cirrhosis for people with chronic infection with the virus ranges from 15% to 30% over a 20-year period. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- rapid diagnostic test HCV Ab Plus Rapid test
- How many people
- 25,669 participants
- Where
- 2 sitesColombia
- Study dates
- 16 Dec 2023to 31 Dec 2024
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All persons over 18 years of age who are treated in the included health care institutions (IPS) and who are users of hospitalization, emergency, outpatient, and any other hospital care services.
Who may be able to join
- Have at least one of the following risk factors for hepatitis C.
- Over 50 years of age with no risk factors.
- Over 18 years old and less than 50 years old with risk factors for hepatitis C. Persons who have received medical or dental interventions in health care settings.
- Persons who have had tattoos, body piercings, or scarification procedures. Persons with HIV or hepatitis B infection. Persons who inject drugs. Persons who have used intranasal drugs. Persons deprived of liberty and previously incarcerated persons. Anyone with abnormal liver tests or liver disease. Students, health care workers, or members of public safety (e.g. correctional service officers or police) who have come into contact with blood at work through needlestick or sharps injuries. Anyone who has undergone hemodialysis. Persons who received transfusions in Colombia before 1996. Persons with comorbidities potentially associated with CH: diabetes, ischemic heart disease, cryoglobulinemia, chronic renal failure, Sjögren's syndrome, hypothyroidism, lichen planus, rheumatoid arthritis, HIV, non-Hodgkin's lymphoma, acute lymphoblastic leukemia, waldenstrom's macroglobulinemia.
- Individuals previously treated for HCV with sustained viral response in whom reinfection is suspected (individuals who continue to engage in risk behaviors)
- Accept to participate in the study by signing the informed consent form.
Who cannot join
- Have or have had hepatitis C with a proven cure by viral load at 12 weeks after the end of treatment without risk behaviors for reinfection.
- Be on antiviral treatment against chronic hepatitis C virus.
- That the patient voluntarily and consciously refuses to sign the informed consent form or is unable to give it due to any type of physical and/or mental disability.
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites, 2 recruiting
- Recruiting
Hospital Pablo Tobón Uribe
Medellín, Antioquia, 050001
Juan Ignacio Marín Zuluaga, MD, 3006160497, jmarin@hptu.org.co
- Recruiting
Hospital Universitario Julio Méndez Barreneche E.S.E.
Santa Marta, Magdalena Department, 470005
Javier E Hernandez Blanci, MD, +573183483581, jhernandezblanco@gmail.com
Diana Rocio Chavez Bejarano, DRa, +573124541333, dianachavezbejarano@outlook.com
About this study
Introduction: Hepatitis C virus infection is a major cause of chronic hepatitis, cirrhosis, and liver cancer. The risk of developing cirrhosis for people with chronic infection with the virus ranges from 15% to 30% over a 20-year period. According to 2019 data from the World Health Organization there are 58 million people living with chronic hepatitis C infection. Three-quarters of those infected live in low- to middle-income countries, some of which lack budgets for screening, diagnosis and treatment campaigns. While good progress has been made in several countries, a significant gap in testing and treatment remains. Barriers to timely diagnosis include lack of awareness on the part of health professionals, availability and access to screening tests. Simplifying the cascade of care for this pathology would help ensure that more patients remain involved in the care pathway and ultimately achieve global goals.
Objective: To estimate the prevalence of anti-HCV antibodies in patients with risk factors for hepatitis C virus captured by opportunity screening in the included hospital institutions.
Methodology: Descriptive multicenter cross-sectional study. A total of 27160 participants among the seven institutions, 3880 per institution. Includes all persons over 18 years of age attended in the included health service provider institutions (IPS) who are users of hospitalization, emergency, outpatient and any other hospital care services. Application of a questionnaire to identify the inclusion criteria and data collection, signature of informed consent, sample collection by rapid test Abbott HCV rapid test - BIOLINE HCV and evaluation by tele-consultation by hepatologist principal investigator who will guide you to access the confirmatory test for HCV (viral load for Hepatitis C), the study will assume responsibility for its realization.
Read the detailed description
Research question
¿What is the prevalence of HCV in the population with risk factors for hepatitis C virus infection captured by screening with rapid tests in health care institutions in Colombia?
Through this observational, multicenter, hospital population study, the prevalence will be determined by screening patients with risk factors for hepatitis C by rapid antibody test, to subsequently perform confirmation with viral load PCR in those seropositive. In addition, support will be provided to patients to facilitate their treatment adherence.
The benefits would be related to raising awareness of the importance of the active search for these patients, reducing the health impact for the screened population, incorporating these strategies in the country's hospital institutions, and obtaining epidemiological information that helps to understand the magnitude of the disease and the opportunity for its elimination.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- rapid diagnostic test HCV Ab Plus Rapid test
- Keywords
- prevalence, rapid diagnostic tests
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid diagnostic test HCV Ab Plus Rapid testDiagnostic test
Also called Opportunity screening
The sample will be taken by trained personnel by capillary puncture of the thumb region of the fingers of the right hand, after asepsis and antisepsis, the rapid diagnostic test HCV Ab Plus Rapid test with INVIMA registration 2018RD-0002353-R1 will be used with operational characteristics that allow its performance at the point of care obtaining a result in 15 to 20 minutes. This rapid test for antibodies against HCV may be replaced by another test with similar operational characteristics (sensitivity and specificity).
| Study group | Role | What they receive |
|---|---|---|
| Adults with risk factors for hepatitis C virus | All persons over 18 years of age who are treated in the included health care institutions (IPS) and who are users of hospitalization, emergency, outpatient, and any other hospital care services. Receives: Diagnostic Test: rapid diagnostic test HCV Ab Plus Rapid test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence
Hepatitis C virus prevalence
Measured: 12 months
Secondary outcomes (1)
Opportunity for treatment
Access to treatment for hepatitis C virus infection
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start16 Dec 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25,669 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociación Colombiana de Hepatología
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Pablo Tobón Uribe
- Responsible party
- Principal investigator, Diana Rocio Chavez Bejarano, Asociación Colombiana de Hepatología
- Investigators
- Javier Hernández Blanco, MD, Study director, Asociación Colombiana de Hepatología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155006
- Sponsor's protocol ID
- CO-US-987-6934
- Other IDs
- CO-US-987-6934
- Acronym
- HCVLINKAGE
- Status last verified
- Jun 2024
- First submitted
- 24 Nov 2023
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Informed consent will be requested in written form to all participants, giving clear and easily understandable information about the objectives of the research. The consent will be explained and doubts about it will be resolved and complete freedom of withdrawal of consent will be given at any time during the study, for the reasons that the subject considers. The study will be coordinated by health professionals and the sampling and data collection will be performed by nursing assistants trained in rapid tests. The confidentiality of the data collected will be guaranteed, the information obtained will not be used for purposes other than the current research process, and sensitive data or data that allow the identification of the participating individuals will not be published when the information is disclosed.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Screening for Hepatitis c and Linkage to Treatment in Hospitals in Colombia
- ClinicalTrials.gov ID
- NCT06155006
- Acronym / sponsor ID
- HCVLINKAGE / CO-US-987-6934
- Conditions
- Hepatitis C Virus Infection
- Keywords
- prevalence, rapid diagnostic tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25,669 participants (estimated)
- Lead sponsor
- Asociación Colombiana de HepatologíaUniversity, hospital or other
- Collaborators
- Hospital Pablo Tobón Uribe
- Study start
- 16 Dec 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Dec 2023 (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.
Introduction: Hepatitis C virus infection is a major cause of chronic hepatitis, cirrhosis, and liver cancer. The risk of developing cirrhosis for people with chronic infection with the virus ranges from 15% to 30% over a 20-year period. According to 2019 data from the World Health Organization there are 58 million people living with chronic hepatitis C infection. Three-quarters of those infected live in low- to middle-income countries, some of which lack budgets for screening, diagnosis and treatment campaigns. While good progress has been made in several countries, a significant gap in testing and treatment remains. Barriers to timely diagnosis include lack of awareness on the part of health professionals, availability and access to screening tests. Simplifying the cascade of care for this pathology would help ensure that more patients remain involved in the care pathway and ultimately achieve global goals.
Objective: To estimate the prevalence of anti-HCV antibodies in patients with risk factors for hepatitis C virus captured by opportunity screening in the included hospital institutions.
Methodology: Descriptive multicenter cross-sectional study. A total of 27160 participants among the seven institutions, 3880 per institution. Includes all persons over 18 years of age attended in the included health service provider institutions (IPS) who are users of hospitalization, emergency, outpatient and any other hospital care services. Application of a questionnaire to identify the inclusion criteria and data collection, signature of informed consent, sample collection by rapid test Abbott HCV rapid test - BIOLINE HCV and evaluation by tele-consultation by hepatologist principal investigator who will guide you to access the confirmatory test for HCV (viral load for Hepatitis C), the study will assume responsibility for its realization.
Detailed description
Research question
¿What is the prevalence of HCV in the population with risk factors for hepatitis C virus infection captured by screening with rapid tests in health care institutions in Colombia?
Through this observational, multicenter, hospital population study, the prevalence will be determined by screening patients with risk factors for hepatitis C by rapid antibody test, to subsequently perform confirmation with viral load PCR in those seropositive. In addition, support will be provided to patients to facilitate their treatment adherence.
The benefits would be related to raising awareness of the importance of the active search for these patients, reducing the health impact for the screened population, incorporating these strategies in the country's hospital institutions, and obtaining epidemiological information that helps to understand the magnitude of the disease and the opportunity for its elimination.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with risk factors for hepatitis C virus | – | Diagnostic Test: rapid diagnostic test HCV Ab Plus Rapid testAll persons over 18 years of age who are treated in the included health care institutions (IPS) and who are users of hospitalization, emergency, outpatient, and any other hospital care services. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All persons over 18 years of age who are treated in the included health care institutions (IPS) and who are users of hospitalization, emergency, outpatient, and any other hospital care services.
Key inclusion criteria (6 listed)
- Have at least one of the following risk factors for hepatitis C.
- Over 50 years of age with no risk factors.
- Over 18 years old and less than 50 years old with risk factors for hepatitis C. Persons who have received medical or dental interventions in health care settings.
- Persons who have had tattoos, body piercings, or scarification procedures. Persons with HIV or hepatitis B infection. Persons who inject drugs. Persons who have used intranasal drugs. Persons deprived of liberty and previously incarcerated persons. Anyone with abnormal liver tests or liver disease. Students, health care workers, or members of public safety (e.g. correctional service officers or police) who have come into contact with blood at work through needlestick or sharps injuries. Anyone who has undergone hemodialysis. Persons who received transfusions in Colombia before 1996. Persons with comorbidities potentially associated with CH: diabetes, ischemic heart disease, cryoglobulinemia, chronic renal failure, Sjögren's syndrome, hypothyroidism, lichen planus, rheumatoid arthritis, HIV, non-Hodgkin's lymphoma, acute lymphoblastic leukemia, waldenstrom's macroglobulinemia.
- Individuals previously treated for HCV with sustained viral response in whom reinfection is suspected (individuals who continue to engage in risk behaviors)
Key exclusion criteria (3 listed)
- Have or have had hepatitis C with a proven cure by viral load at 12 weeks after the end of treatment without risk behaviors for reinfection.
- Be on antiviral treatment against chronic hepatitis C virus.
- That the patient voluntarily and consciously refuses to sign the informed consent form or is unable to give it due to any type of physical and/or mental disability.
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 |
|---|---|---|
| rapid diagnostic test HCV Ab Plus Rapid testAlso: Opportunity screeningThe sample will be taken by trained personnel by capillary puncture of the thumb region of the fingers of the right hand, after asepsis and antisepsis, the rapid diagnostic test HCV Ab Plus Rapid test with INVIMA registration 2018RD-0002353-R1 will be used with operational characteristics that allow its performance at the point of care obtaining a result in 15 to 20 minutes. This rapid test for antibodies against HCV may be replaced by another test with similar operational characteristics (sensitivity and specificity). | Diagnostic test | Adults with risk factors for hepatitis C virus |
Primary outcome
Prevalence
Time frame: 12 months
Hepatitis C virus prevalence
1 secondary outcome
Opportunity for treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No. Informed consent will be requested in written form to all participants, giving clear and easily understandable information about the objectives of the research. The consent will be explained and doubts about it will be resolved and complete freedom of withdrawal of consent will be given at any time during the study, for the reasons that the subject considers. The study will be coordinated by health professionals and the sampling and data collection will be performed by nursing assistants trained in rapid tests. The confidentiality of the data collected will be guaranteed, the information obtained will not be used for purposes other than the current research process, and sensitive data or data that allow the identification of the participating individuals will not be published when the information is disclosed.
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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.
Javier Hernández Blanco, MD study director
Asociación Colombiana de Hepatología
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus Infection, run by Asociación Colombiana de Hepatología at 2 sites in Colombia.
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 6 inclusion and 3 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 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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 Javier Hernández Blanco, DR (+57 318 3483581, jhernandezblanco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (time frame: 12 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 10 Jun 2024.