Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463912
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-06
Brief Title:
Screening for Hepatitis c in People Who Inject Drugs in Armenia-Colombia
Sponsor:
Asociación Colombiana de Hepatología
Organization:
Asociación Colombiana de Hepatología
Study Overview
Official Title:
Screening for Hepatitis c in People Who Inject Drugs in Armenia-Colombia
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCV-PIWD
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 23 million coinfections between HIV and HCV worldwide of which more than half 13 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 502 which is equivalent to 56 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 17 in 2002 to 67 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 802 is the city with the highest reactivity followed by Pereira and Dos Quebradas with 714 Armenia with 696 and Cucuta with 628 We do not have recent data about the impact of intervention to reduce HVC transmission in those groups
Worldwide there are around 11 million PWIDs and there are approximately 23 million coinfections between HIV and HCV worldwide of which more than half 13 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 502 which is equivalent to 56 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 17 in 2002 to 67 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 802 is the city with the highest reactivity followed by Pereira and Dos Quebradas with 714 Armenia with 696 and Cucuta with 628 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None