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

Completed

• Conditions: Hepatitis C; Harm Reduction; HIV; Drug Users
• Interventions: Other: Screening for HCV in PWID and Linkage-To-Care

• Registration Number: NCT02971488
• Lead Sponsor: Hospital Universitario Infanta Leonor

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-11-19
• Study First Posted: 2016-11-23
• Study Start: 2017-01-15
• Primary Completion: 2018-12-31
• Study Completion: 2019-05-10
• Results First Submitted: 2019-05-12
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-09
• Last Update Submitted: 2019-08-09
• Results First Posted: 2019-09-13
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 529

Inclusion Criteria

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persons who inject drugs (PWID)	Screening for HCV in PWID and Linkage-To-Care	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.

Primary Outcome Measures

Name	Time	Method
Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to	2 years	Percentage of participants who had a positive HCV test and results of the test was delivered to them.
Percentage of Participants Who Started HCV Antiviral Therapy.	2 years	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).
Percentage of Participants Who Achieved a Sustained Virological Response (SVR)	2 years	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).
Percentage of Participants Who Were Evaluated at a HCV Clinic.	2 years	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Active HCV in Screened Population	2 years	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.
Prevalence of Other Chronic Viral Infections in the Population Screened	2 years	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.