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

Mental Disease Clinical Trial

— HONEST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03932396
• Other study ID #: HONEST
• Status: Not yet recruiting
• Start date: May 10, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2019
• Source: Instituto de Investigación Marqués de Valdecilla
• Contact: Antonio Cuadrado Lavín, MD
• Phone: 942202544
• Email: antonio.cuadrado[@]scsalud.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Addictive Behaviours o Conducts
• Behavior, Addictive
• Hepatitis
• Hepatitis C
• Hepatotropic Virus Infection
• Mental Disease
• Mental Disorders
• People Sentenced to Non-custodial Sentences
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects screened for anti-HCV		From march of 2019 to march of 2021
Primary	Percentage of anti-HCV positive		From march of 2019 to march of 2021
Primary	Number of anti-HCV positive subjects with detectable viremia		From march of 2019 to march of 2021
Primary	Percentage of subjects with detectable viremia		From march of 2019 to march of 2021
Primary	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
Primary	Number of subjects screened for mental illness.		From march of 2019 to march of 2021
Primary	Percentage of subjects with mental illness		From march of 2019 to march of 2021
Primary	Number of subjects screened for drug addiction		From march of 2019 to march of 2021
Primary	Percentage of subjects with drug addiction		From march of 2019 to march of 2021
Primary	Number of subjects linked to the Chronicity Program of the Government of Cantabria		From march of 2019 to march of 2021
Primary	Percentage of subjects linked to the Chronicity Program of the Government of Cantabria		From march of 2019 to march of 2021
Primary	Number of subjects linked to the Extended Bridge program of Penitentiary Institutions		From march of 2019 to march of 2021
Primary	Percentage of subjects linked to the Extended Bridge program of Penitentiary Institutions		From march of 2019 to march of 2021
Primary	Number of subjects served by the Navigator		From march of 2019 to march of 2021
Primary	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