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HCVLINKAGE
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Colombian Association of Hepatology
observational
25,669
1 country
2
Study Start
December 16, 2023
Actual (reported)Primary Completion
October 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 24, 2023
Actual (reported)December 4, 2023
Actual (reported)December 16, 2023
Actual (reported)October 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Prevalence
Hepatitis C virus prevalence
12 months
Opportunity for treatment
12 months
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.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Hospital Pablo Tobón Uribe
Medellín, Antioquia, 050001, Colombia
Hospital Universitario Julio Méndez Barreneche E.S.E.
Santa Marta, Magdalena Department, 470005, Colombia
Javier Hernández Blanco, MD
Asociación Colombiana de Hepatología
First Submitted
November 24, 2023
First Posted
December 4, 2023
Study Start
December 16, 2023
Actual (reported)Primary Completion
October 30, 2024
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 10, 2024
Record last verified: 2024-06
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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Source: ClinicalTrials.gov.
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