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| ID | Type | Description | Link |
|---|---|---|---|
| CO-US-987-6934 | Other Grant/Funding Number | Colombian Association of Hepatology |
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| Name | Class |
|---|---|
| Hospital Pablo Tobón Uribe | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rapid diagnostic test HCV Ab Plus Rapid test | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence | Hepatitis C virus prevalence | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Opportunity for treatment | Access to treatment for hepatitis C virus infection | 12 months |
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Inclusion Criteria:
Have at least one of the following risk factors for hepatitis C.
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.
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier Hernández Blanco, DR | Contact | +57 318 3483581 | jhernandezblanco@gmail.com | |
| Diana Chávez Bejarano, Dra | Contact | +57 3124541333 | dianachavezbejarano@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Javier Hernández Blanco, MD | Asociación Colombiana de Hepatología | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pablo Tobón Uribe | Recruiting | Medellín | Antioquia | 050001 | Colombia |
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2023 | Nov 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| Hospital Universitario Julio Méndez Barreneche E.S.E. | Recruiting | Santa Marta | Magdalena Department | 470005 | Colombia |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |