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

Hepatitis C Virus Infection Clinical Trial

— HCV-PIWD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06463912
• Other study ID #: CO-US-987-7106
• Status: Recruiting
• Start date: May 20, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: Asociación Colombiana de Hepatología
• Contact: Javier Hernández Blanco, MD
• Phone: +57 318 3483581
• Email: jhernandezblanco[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 205
• Est. completion date: March 31, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Colombia	Colombian Association of Hepatology	Armenia	Quindio

Sponsors (1)

Lead Sponsor	Collaborator
Asociación Colombiana de Hepatología

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV antibody prevalence rate	Hepatitis C virus prevalence	10 months
Secondary	Proportion of patients with access to HCV treatment	Access to treatment for hepatitis C virus infection	10 months