A Novel Hepatitis c micrOelimination Program in Non imprisonEd SenTenced With Alternative Measures

Study Overview
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Brief Summary
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The objective of this study is to carry out a Micro-elimination program for HCV infection in a vulnerable population (people sentenced to non-custodial sentences). This group shares certain peculiarities with the prison population (vulnerability, addictions, mental disorders, etc.), is three times higher than the imprisoned population, and is regularly attended by Social Insertion Centers (CIS) in Spain. An additional objective is to link these people with the specific plans of the Government of Cantabria (Chronicity Plan, Care for Serious Mental Disorders, Harm Reduction Programs and the Center for Attention to Drug Addicts) as well as the Extended Bridge Program for Penitentiary Institutions, implementing the figure of a Navigator (a specialized professional in charge of helping subjects overcome barriers). It is an observational study based on the screening of disease in accordance with the recommendations of the health authorities. Once detected, patients will be referred to the corresponding specialized care following the usual clinical practice.

Official Title
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A Novel Hepatitis c micrOelimination Program in Non imprisonEd SenTenced With Alternative Measures

Conditions
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Hepatotropic Virus Infection, Addictive Behaviours o Conducts, Mental Disease, People Sentenced to Non-custodial Sentences

Intervention / Treatment
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* Other: Observational study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the entire population served in the Management of Penalties and Alternative Measures Service (SGPMA) of the José Hierro SIC, including new admissions within the study period. Exclusion Criteria: they are not willing to participate and do not sign informed consent.

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single group of subjects who fulfill the inclusion criteria<br>All the population condemned to a non-custodial sentence that is presented in the Service of Management of Penalties and Alternative Measures of the Center of Social Insertion (CIS) José Hierro CP Dueso during the study period (March 2019 and March 2021) , with ages between 18 and 79 years (approximately 1000 people / year) and willing to participate (signs the IC). | Other: Observational study<br>* No intervention is planned outside of usual clinical practice. Only active screening for hepatotropic virus infection, mainly hepatitis C virus, HIV, and mental illness will be carried out. If any disease is detected, patients will be referred to the corresponding specialized care following the usual clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects screened for anti-HCV |  | From march of 2019 to march of 2021 | 
| Percentage of anti-HCV positive |  | From march of 2019 to march of 2021 | 
| Number of anti-HCV positive subjects with detectable viremia |  | From march of 2019 to march of 2021 | 
| Percentage of subjects with detectable viremia |  | From march of 2019 to march of 2021 | 
| To detect other comorbidities such as mental disorders, drug dependencies in this population and link these patients with specific health care programs of Penitentiary Institutions (Extended Bridge Program) and the Government of Cantabria (Chronicity and |  | From march of 2019 to march of 2021 | 
| Number of subjects screened for mental illness. |  | From march of 2019 to march of 2021 | 
| Percentage of subjects with mental illness |  | From march of 2019 to march of 2021 | 
| Number of subjects screened for drug addiction |  | From march of 2019 to march of 2021 | 
| Percentage of subjects with drug addiction |  | From march of 2019 to march of 2021 | 
| Number of subjects linked to the Chronicity Program of the Government of Cantabria |  | From march of 2019 to march of 2021 | 
| Percentage of subjects linked to the Chronicity Program of the Government of Cantabria |  | From march of 2019 to march of 2021 | 
| Number of subjects linked to the Extended Bridge program of Penitentiary Institutions |  | From march of 2019 to march of 2021 | 
| Percentage of subjects linked to the Extended Bridge program of Penitentiary Institutions |  | From march of 2019 to march of 2021 | 
| Number of subjects served by the Navigator |  | From march of 2019 to march of 2021 | 
| Number of subjects with an average rating greater than 4 on a Likert scale of 5 points of satisfaction with the Navigator |  | From march of 2019 to march of 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C virus, non-custodial sentences, addictive behaviours, Mental disease, Navigator, screening, POCT