Adult Screening for Hepatitis c and Linkage to Treatment in Hospitals in Colombia
HCVLINKAGE
1 other identifier
observational
25,669
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2023
CompletedFirst Posted
Study publicly available on registry
December 4, 2023
CompletedStudy Start
First participant enrolled
December 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 10, 2024
June 1, 2024
11 months
November 24, 2023
June 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence
Hepatitis C virus prevalence
12 months
Secondary Outcomes (1)
Opportunity for treatment
12 months
Study Arms (1)
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.
Interventions
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).
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asociación Colombiana de Hepatologíalead
- Hospital Pablo Tobón Uribecollaborator
Study Sites (2)
Hospital Pablo Tobón Uribe
Medellín, Antioquia, 050001, Colombia
Hospital Universitario Julio Méndez Barreneche E.S.E.
Santa Marta, Magdalena Department, 470005, Colombia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Javier Hernández Blanco, MD
Asociación Colombiana de Hepatología
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Epidemiology
Study Record Dates
First Submitted
November 24, 2023
First Posted
December 4, 2023
Study Start
December 16, 2023
Primary Completion
October 30, 2024
Study Completion
December 31, 2024
Last Updated
June 10, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share
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.