Status:
NOT_YET_RECRUITING
HEPATITIS C SCREENING in ADULTS with RISK FACTORS in FIVE CITIES of COLOMBIA'S CARIBBEAN COAST (FIVE-CC)
Lead Sponsor:
Diana Rocio Chavez Bejarano
Conditions:
Chronic Hepatitis C Infection
Eligibility:
All Genders
18+ years
Brief Summary
Hepatitis C virus (HCV) infection is a significant cause of chronic hepatitis, cirrhosis, and liver cancer (1). The risk of developing cirrhosis in people with chronic HCV infection ranges between 15%...
Detailed Description
As of 2017, according to a WHO report, only 20% of people with HCV worldwide had been diagnosed (18). Micro- elimination strategies targeting small populations, rather than nationwide elimination prog...
Eligibility Criteria
Inclusion
- Present at least one of the following risk factors for hepatitis C:
- People over 50 years old with or without risk factors.
- People aged 18 and under 50 years old with risk factors for hepatitis C:
- Individuals who have undergone medical or dental interventions in healthcare settings, Individuals with tattoos, body piercings, or scarification, Individuals co-infected with HIV or hepatitis B, People who inject drugs, Individuals who have used intranasal drugs, Individuals currently or previously incarcerated, Anyone with abnormal liver tests or liver disease, Healthcare students, workers, or public safety personnel (e.g., prison officers or police) who have been exposed to blood at work through needle-stick injuries or sharp objects, Sex workers, Men who have sex with men, Users of port health services, Reinserted or reintegrated individuals, Anyone who has undergone hemodialysis, Individuals who received blood transfusions in Colombia before 1996, People with comorbidities potentially associated with HC: diabetes, ischemic heart disease, cryoglobulinemia, chronic kidney disease, Sjögren's syndrome, hypothyroidism, lichen planus, rheumatoid arthritis, HIV, non-Hodgkin's lymphoma, acute lymphoblastic leukemia, Waldenström's macroglobulinemia, Individuals previously treated for HCV with a sustained viral response, where reinfection is suspected (individuals who continue to engage in risk behaviors). Confirmation testing through HCV viral load (PCR HCV) will be considered for inclusion in the study.
- \- Agree to participate in the study by signing an informed consent form.
Exclusion
- Have had hepatitis C within the last three months with a confirmed cure by viral load 12 weeks after treatment or are actively receiving treatment for HCV and do not continue to engage in risk behaviors for reinfection.
- Voluntarily and knowingly refuse to sign the informed consent form or are unable to provide consent due to any type of physical and/or mental disability.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT06899542
Start Date
April 1 2025
End Date
October 1 2025
Last Update
March 28 2025
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