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

NCT03932396 | Unknown

• 1 other identifier: HONEST
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

hepatitis C virus; non-custodial sentences; addictive behaviours; Mental disease; Navigator; screening; POCT

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (1)

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).

Other: Observational study

Interventions

Observational study OTHER

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.

Single group of subjects who fulfill the inclusion criteria

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 (SIC) 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).

You may qualify if:

• 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.

You may not qualify if:

• they are not willing to participate and do not sign informed consent.

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

Study Sites (1)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Related Publications (2)

• Cuadrado A, Llerena S, Cobo C, Pallas JR, Mateo M, Cabezas J, Fortea JI, Alvarez S, Pellon R, Crespo J, Echevarria S, Ayesa R, Setien E, Lopez-Hoyos M, Crespo-Facorro B, Aguero 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.

  PMID: 29946175 BACKGROUND

• 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.

  PMID: 23419824 RESULT

MeSH Terms

Conditions

Mental Disorders; Hepatitis C

Interventions

Observation

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Antonio Cuadrado Lavín, MD

CONTACT

942202544; antonio.cuadrado@scsalud.es

Lucía Lavín Alconero, Bsc,PhD

CONTACT

942203373; eclinicos5@idival.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 30, 2019
• Study Start: May 10, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 31, 2021
• Last Updated: April 30, 2019

Record last verified: 2019-04

Locations

ES (1)