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

NCT06899542 | Not Yet Recruiting

• 1 other identifier: CO-US-987-7107
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

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% 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

Keywords

Hepatitis C, general population.

Outcome Measures

Primary Outcomes (1)

• hepatitis C viremic

  HCV RNA detectable by quantitative method.

  5months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All individuals over the age of 18 with HCV risk factors, including the general population and vulnerable populations at higher risk of chronic hepatitis C infection, recruited from healthcare institutions or during screening campaigns in various settings.

You may qualify if:

• 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:
• \- Agree to participate in the study by signing an informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diana Rocio Chavez Bejarano: lead

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• JAVIER E HERNANDEZ-BLANCO, DR

  Asociación Colombiana de Hepatología

  PRINCIPAL INVESTIGATOR

• ISMAEL YEPES, DR

  Asociación Colombiana de Hepatología

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JAVIER E HERNANDEZ-BLANCO, DR

CONTACT

57 3183483581; JHERNANDEZBLANCO@GMAIL.COM

PATRICIA TORRES, SRA.

CONTACT

57 3006844875; SOPORTE@HIGADOCOLOMBIA.ORG

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DR.

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: April 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share