Acceptance and Feasibility of Hepatitis c Screening Strategies in Social Insertion Centers

Study Overview
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Brief Summary
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Hepatitis C virus (HCV) infection is one of the leading causes of chronic liver disease worldwide. It is a progressive disease that without treatment leads to the development of cirrhosis in approximately 10-20% of patients. With this study the investigators intend to evaluate the efficacy defined as the rate of HCV diagnostic tests performed within a decentralized diagnostic strategy by means of home self-testing compared to the one performed in situ in the population served in Social Insertion Centers (CIS) with alternative prison sentences, in order to study the prevalence and characteristics associated with HCV infection in this population, which is known to be at risk for this disease, and to offer them treatment and cure.

Detailed Description
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A randomized study will be designed in which all persons attending the Social Insertion Center to serve alternative sentences to prison will be invited to participate on a voluntary basis, with prior informed consent. In order to study the prevalence of these persons compared to persons in open system, the latter will be offered, with prior informed consent, to take the diagnostic test in situ at the CIS premises. All persons will be given a survey with sociodemographic and clinical variables to identify predictor factors. People with alternative sentences to prison will be informed of the study and, according to the randomization code, will be: a) given an envelope with all the necessary material to carry out the test at home and send it to the hospital for processing or, b) be tested on site at the CIS premises by the CIS nurse, who will also send it to the hospital for processing within 30 days by the Central Laboratory of the University Hospital of the Canary Islands.

Official Title
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Acceptance and Feasibility of Hepatitis c Screening Strategies in Social Insertion Centers With Alternative Sentences to Prison and Open System

Conditions
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Hepatitis C Virus

Intervention / Treatment
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* Diagnostic Test: Dried blood spot testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All persons attending the Social Insertion Center for the first time with alternative sentences to prison and in open system. Signed informed consent. Exclusion Criteria: Refusal of the patient to participate in the study. Minors under 18 years of age and over 79 years of age.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized study will be designed in which all persons attending the Social Insertion Center (CIS) to serve alternative sentences to prison will be invited to participate. In order to study the prevalence of these persons compared to persons in open system, the latter will be offered to take the diagnostic test in situ at the CIS premises. Persons with alternative sentences to prison will be informed of the study and, according to the randomization code, will be: a) given an envelope with all the necessary material to carry out the test at home and send it to the hospital for processing or, b) be tested on site at the CIS premises, who will also send it to the hospital for processing by the Central Laboratory of the University Hospital of the Canary Islands. All patients who have participated will be notified by telephone of the test result, and patients with a diagnosis of active infection will be contacted and given an appointment to be evaluated and treated.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alternative sentences to prison<br>Persons with alternative sentences to prison will be informed of the study and, according to the randomization code, will be: a) given an envelope with all the necessary material to carry out the test at home and send it to the hospital for processing or, b) be tested on site at the the Social Insertion Center premises, who will also send it to the hospital for processing by the Central Laboratory of the University Hospital of the Canary Islands. | Diagnostic Test: Dried blood spot testing<br>* To evaluate the efficacy defined as the rate of diagnostic tests against hepatitis C virus (HCV) performed with a dried blood spot test<br>|
| Experimental: Open system<br>They will be offered to take the diagnostic test in situ at the the Social Insertion Center premises. | Diagnostic Test: Dried blood spot testing<br>* To evaluate the efficacy defined as the rate of diagnostic tests against hepatitis C virus (HCV) performed with a dried blood spot test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants in a HCV screening strategy | To evaluate the efficacy defined as the rate of diagnostic tests against hepatitis C virus (HCV) performed within a decentralized diagnostic strategy integrated by self-testing at home compared to that performed in situ in the population served in a Social Insertion Center with alternative prison sentences. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of HCV | To study the prevalence and characteristics of patients with active HCV infection who are treated in the Social Insertion Center with alternative prison sentences compared to those in open system, so better and more specialized screening strategies are developed. | 1 year |