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

NCT ID: NCT06463912

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 205 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2025-03-31

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.

Detailed Description

Research question

¿What is the prevalence of HCV in the PWID in the City of Armenia-Colombia? Through this observational study, the prevalence will be determined by screening PWID for hepatitis C by rapid HCV antibody test, to subsequently perform confirmation with viral load PCR in those seropositive. In addition, support will be provided to patients to facilitate their treatment and linkage to care. The use of a respondent-driven sampling (RDS) method will permit obtaining a statistically valid sample.

The objective of this study is to estimate the prevalence of anti-HCV antibodies in PWID between 18 and 65 years of age in the municipality of Armenia (Quindío) through public health strategies such as screening that allows characterize the affected people and facilitate access to diagnosis and treatment.

Conditions

Hepatitis C Virus Infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

People who inject drugs in Armenia-Colombia

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

Does not apply

Intervention Type: 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).

Interventions

Does not apply

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).

Intervention Type: OTHER

Other Intervention Names

Opportunity screening

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asociación Colombiana de Hepatología

OTHER

Sponsor Role: lead

Responsible Party

Diana Rocio Chavez Bejarano

Bacteriologist Clinical Epidemiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Javier Hernández Blanco, MD

Role: STUDY_DIRECTOR

Asociación Colombiana de Hepatología

Locations

Colombian Association of Hepatology

Armenia, Quindío Department, Colombia

Site Status: RECRUITING

Countries

Colombia

Central Contacts

Javier Hernández Blanco, MD

Role: CONTACT

jhernandezblanco@gmail.com

+57 318 3483581

Diana Chávez Bejarano, Bac

Role: CONTACT

dianachavezbejarano@outlook.com

+57 3124541333

Facility Contacts

Juan Ignacio Marín Zuluaga, MD

Role: primary

jmarin@hptu.org.co

3006160497

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

CO-US-987-7106

Identifier Type: -

Identifier Source: org_study_id