Adult Screening for Hepatitis c and Linkage to Treatment in Hospitals in Colombia

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: t
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⁃ 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.

Locations
Other Locations
Colombia
Hospital Pablo Tobón Uribe
RECRUITING
Medellín
Hospital Universitario Julio Méndez Barreneche E.S.E.
RECRUITING
Santa Marta
Contact Information
Primary
Javier Hernández Blanco, DR
jhernandezblanco@gmail.com
+57 318 3483581
Backup
Diana Chávez Bejarano, Dra
dianachavezbejarano@outlook.com
+57 3124541333
Time Frame
Start Date: 2023-12-16
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 25669
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Pablo Tobón Uribe
Leads: Asociación Colombiana de Hepatología

This content was sourced from clinicaltrials.gov