The Impact on Linkage-to-care of an Alternative Hepatitis C Screening Method in PWID

Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population. More frequent diagnosis, new methods that prevent loss of tracking, and access to antiviral treatment are all strategies that must be implemented jointly if the prevalence of HCV infection in our setting is to be reduced.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; HIV; Harm Reduction; Drug Users
• Intervention / Treatment: Other: Screening for HCV in PWID and Linkage-To-Care

• Study Type: Observational
• Enrollment (Actual): 529

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population comprises persons who visit the Cañada Real Galiana shantytown on the outskirts of Madrid, where 90% of illegal drugs in the region are sold and consumed. It is estimated that between 4000 and 6000 people per day visit the shantytown for their dose. The regional government's Anti-Drug Agency has a mobile HRU operating daily in the area. The unit provides screening tests to anyone who is willing to take them, regardless of whether they are already aware of their serological status or not. Screening includes education on prevention of HCV infection and other transmissible diseases.

Description

Inclusion Criteria:

• PWID
• >18 years of age
• Signed consent form

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Persons who inject drugs (PWID); The study population comprises persons who visit the Cañada Real Galiana shantytown on the outskirts of Madrid, where 90% of illegal drugs in the region are sold and consumed.	Other: Screening for HCV in PWID and Linkage-To-Care; Screening, diagnosis and treatment of HCV in PWID, will be part of a harm reduction strategy. Treatment of HCV infected PWID will be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to	Percentage of participants who had a positive HCV test and results of the test was delivered to them.	2 years
Percentage of Participants Who Were Evaluated at a HCV Clinic.	Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).	2 years
Percentage of Participants Who Started HCV Antiviral Therapy.	Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).	2 years
Percentage of Participants Who Achieved a Sustained Virological Response (SVR)	Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Active HCV in Screened Population	Screening for HCV using dried blood samples on WhatmanTM cards in subjects from Cañada Real based on the results of the laboratory tests performed in phase I. The percentage of active HCV infections will be calculated from the total population of active drug addicts screened.	2 years
Prevalence of Other Chronic Viral Infections in the Population Screened	Other viruses (HIV, HBV, HDV) using dried blood samples on WhatmanTM cards in subjects from Cañada Real based will be analysed. The prevalence of these infections will be calculated base on the total screened population.	2 years

Collaborators and Investigators

• Sponsor: Hospital Universitario Infanta Leonor
• Collaborators: Fundacion SEIMC-GESIDA; Instituto de Salud Carlos III

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: November 19, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Hepatitis C; PWID; Linkage-to-care
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: HUIL 15/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: not shared in public