Screening for Hepatitis c in People Who Inject Drugs in Armenia-Colombia

NCT06463912 | Recruiting

• 1 other identifier: CO-US-987-7106
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

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 20 years. Despite undeniable advances in the treatment of hepatitis C infection and the WHO strategy to eliminate hepatitis C by 2030, this infection continues to be a major public health problem globally and many HCV-positive individuals are unaware of their HIV status. People who inject drugs (PWID) are at increased risk for HCV. Several studies have reported high HCV prevalence rates, especially among PWID. PWID are usually exposed to a higher risk of various infectious diseases, mainly due to their drug consumption behaviors and habits, in addition to the risks and harms associated with the respective routes of self-administration. Worldwide, there are around 11 million PWIDs and there are approximately 2.3 million coinfections between HIV and HCV worldwide, of which more than half (1.3 million) occur in PWID. The coexistence of these two health conditions leads to accelerate the progression of liver disease. The global prevalence of HCV in 2019 among PWID was 50.2%, which is equivalent to 5.6 million people who inject drugs and live with hepatitis C. PWID had been considered a difficult group to reach, manage, and treat because HCV treatment management in these individuals is challenging and they have a higher risk of reinfection and some past HCV treatment guidelines excluded PWIDs from consideration, citing concerns about adherence, increased susceptibility to side effects, and reinfection. However, there is now compelling evidence that HCV treatment is safe and effective among PWID. In Colombia, the prevalence of hepatitis C among PWID has been measured locally in some cities. In Bogotá, it went from 1.7% in 2002 to 6.7% in 2014. For 2021, the prevalence of hepatitis C was measured in Bogotá, Medellín, Santiago de Cali, the metropolitan area of Pereira, Dos Quebradas, Medellín, Cucuta, and Armenia. The results of prevalence of antibodies against hepatitis C were as follows: Cali with 80.2%, is the city with the highest reactivity, followed by Pereira and Dos Quebradas with 71.4%, Armenia with 69.6%, and Cucuta with 62.8%. We do not have recent data about the impact of intervention to reduce HVC transmission in those groups.

Conditions

Hepatitis C Virus Infection

Keywords

Hepatitis C chronic; Drug Use; Hepatitis C Antibodies rapid test

Outcome Measures

Primary Outcomes (1)

• HCV antibody prevalence rate

  Hepatitis C virus prevalence

  10 months

Secondary Outcomes (1)

• Proportion of patients with access to HCV treatment

  10 months

Study Arms (1)

People who inject drugs in Armenia-Colombia

Persons over 18 years who injected drugs (PWID), living in the city of Armenia-Colombia.

Other: Does not apply

Interventions

Does not apply OTHER

A descriptive cross-sectional study will be carried out in the city of Armenia-Colombia. A total of 205 PWID, 18 years to 65 years old will be included. They will be selected through the implementation of the respondent-driven sampling (RDS).

Also known as: Opportunity screening

People who inject drugs in Armenia-Colombia

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All persons over 18 years who injected drugs (PWID) and live in the city of Armenia- Colombia.

You may qualify if:

• Be between 18 and 65 years old.
• Having used injected psychoactive substances in the last six months.
• Residing in the city or metropolitan area of study in the last six months.
• Present the invitation coupon.
• Person with Colombian nationality, Venezuelan migrant population.

You may not qualify if:

• Person who, due to physical, cognitive, or limitations derived from the use of psychoactive substances, is not able to answer the survey autonomously.
• Be in a state of consumption and is prevented from responding to the survey.
• Refuses to collaborate in the study.

Sponsors & Collaborators

• Asociación Colombiana de Hepatología: lead

Study Sites (1)

Colombian Association of Hepatology

Armenia, Quindío Department, 050001, Colombia

RECRUITING

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

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; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier Hernández Blanco, MD

  Asociación Colombiana de Hepatología

  STUDY DIRECTOR

Central Study Contacts

Javier Hernández Blanco, MD

CONTACT

+57 318 3483581; jhernandezblanco@gmail.com

Diana Chávez Bejarano, Bac

CONTACT

+57 3124541333; dianachavezbejarano@outlook.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bacteriologist Clinical Epidemiologist

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 18, 2024
• Study Start: May 20, 2024
• Primary Completion: January 30, 2025
• Study Completion: March 31, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)