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

• Conditions: People Sentenced to Non-custodial Sentences; Hepatotropic Virus Infection; Addictive Behaviours o Conducts; Mental Disease
• Interventions: Other: Observational study

• Registration Number: NCT03932396
• Lead Sponsor: Instituto de Investigación Marqués de Valdecilla

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-29
• Last Update Submitted: 2019-04-29
• Study First Posted: 2019-04-30
• Last Update Posted: 2019-04-30
• Study Start: 2019-05-10
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single group of subjects who fulfill the inclusion criteria	Observational study	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).

Primary Outcome Measures

Name	Time	Method
Number of subjects served by the Navigator	From march of 2019 to march of 2021
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 subjects screened for drug addiction	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 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
Percentage of subjects with drug addiction	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
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 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

Trial Locations

Locations (1)

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain