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HEPATITIS C SCREENING in ADULTS with RISK FACTORS in FIVE CITIES of COLOMBIA'S CARIBBEAN COAST (FIVE-CC)

NCT06899542 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2025-03-28

No results posted yet for this study

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% and 30% over a period of 20 years (2).

In 2016, the World Health Organization (WHO) defined the global strategy for eliminating viral hepatitis (Hepatitis C and Hepatitis B). The goals for hepatitis C include a 90% reduction in new cases of infection and a 65% reduction in mortality (3). To achieve this target by 2030, 90% of people living with hepatitis C need to be diagnosed, and 80% of those individuals must receive treatment, along with reducing the incidence of HCV in high-risk groups (4, 5).

According to 2019 data from the World Health Organization (WHO), 58 million people are living with chronic hepatitis C infection, (2).

Based on information from Colombia's High-Cost Account (CAC), between January 1 and December 31, 2021, 962 people with the infection were identified in Colombia (6). The CAC report for 2021 indicates that the prevalence of chronic HCV was 442, 173, 102, 089, and 25 cases per 100,000 inhabitants for Barranquilla, Soledad, Montería, Cartagena, and Santa Marta, respectively (7). The most common modes of transmission were sexual (72.1%) and parenteral/percutaneous (11.8% of cases) (8).

According to data published by the Polaris Observatory as of 2021, the prevalence in Colombia was estimated at 0.67% (320,000 cases), According to their projections, Colombia is expected to achieve the WHO targets by 2051 under current conditions (9).

Fewer than half of Latin American countries have conducted prevalence studies for HCV, and most of those studies have poor design quality. When extrapolating data from countries with records, the estimated HCV prevalence rate in Latin America is less than 1%. According to the Polaris Observatory's 2019 epidemiological data,only Brazil treated enough patients to achieve a net annual cure rate above 1% of those infected (10).

This study seeks to evaluate the prevalence of hepatitis C through rapid antibody testing and subsequent confirmatory quantitative viral load in the adult population with risk factors in five cities of the Colombian Caribbean coast: Barranquilla, Soledad, Montería, Cartagena, and Santa Marta.

Conditions

  • Chronic Hepatitis C Infection

Sponsors & Collaborators

  • Diana Rocio Chavez Bejarano

    lead OTHER

Principal Investigators

  • JAVIER E HERNANDEZ-BLANCO, DR · Asociación Colombiana de Hepatología

  • ISMAEL YEPES, DR · Asociación Colombiana de Hepatología

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-09-30
Completion
2025-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06899542 on ClinicalTrials.gov