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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 1, 2021

Interventions

  • Other: Observational study
    • 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.

Arms, Groups and Cohorts

  • Single group of subjects who fulfill the inclusion criteria
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects screened for anti-HCV
    • Time Frame: From march of 2019 to march of 2021
  • Percentage of anti-HCV positive
    • Time Frame: From march of 2019 to march of 2021
  • Number of anti-HCV positive subjects with detectable viremia
    • Time Frame: From march of 2019 to march of 2021
  • Percentage of subjects with detectable viremia
    • Time Frame: 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
    • Time Frame: From march of 2019 to march of 2021
  • Number of subjects screened for mental illness.
    • Time Frame: From march of 2019 to march of 2021
  • Percentage of subjects with mental illness
    • Time Frame: From march of 2019 to march of 2021
  • Number of subjects screened for drug addiction
    • Time Frame: From march of 2019 to march of 2021
  • Percentage of subjects with drug addiction
    • Time Frame: From march of 2019 to march of 2021
  • Number of subjects linked to the Chronicity Program of the Government of Cantabria
    • Time Frame: From march of 2019 to march of 2021
  • Percentage of subjects linked to the Chronicity Program of the Government of Cantabria
    • Time Frame: From march of 2019 to march of 2021
  • Number of subjects linked to the Extended Bridge program of Penitentiary Institutions
    • Time Frame: From march of 2019 to march of 2021
  • Percentage of subjects linked to the Extended Bridge program of Penitentiary Institutions
    • Time Frame: From march of 2019 to march of 2021
  • Number of subjects served by the Navigator
    • Time Frame: 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
    • Time Frame: From march of 2019 to march of 2021

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto de Investigación Marqués de Valdecilla
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Antonio Cuadrado Lavín, MD, 942202544, antonio.cuadrado@scsalud.es

References

Cuadrado A, Llerena S, Cobo C, Pallás JR, Mateo M, Cabezas J, Fortea JI, Alvarez S, Pellón R, Crespo J, Echevarría S, Ayesa R, Setién E, Lopez-Hoyos M, Crespo-Facorro B, Agüero J, Chueca N, Garcia F, Calleja JL, Crespo J. Microenvironment Eradication of Hepatitis C: A Novel Treatment Paradigm. Am J Gastroenterol. 2018 Nov;113(11):1639-1648. doi: 10.1038/s41395-018-0157-x. Epub 2018 Jun 27.

Citations Reporting on Results

Blachier M, Leleu H, Peck-Radosavljevic M, Valla DC, Roudot-Thoraval F. The burden of liver disease in Europe: a review of available epidemiological data. J Hepatol. 2013 Mar;58(3):593-608. doi: 10.1016/j.jhep.2012.12.005. Review.

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