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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis C, Drug Users, Harm Reduction, HIV

Intervention / Treatment
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* Other: Screening for HCV in PWID and Linkage-To-Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PWID >18 years of age Signed consent form Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persons who inject drugs (PWID)<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, PWID, Linkage-to-care