Clinical trial NCT03932396: A Novel Hepatitis c micrOelimination Program in Non imprisonEd SenTenced With Alternative Measures
Official title: A Novel Hepatitis c micrOelimination Program in Non imprisonEd SenTenced With Alternative Measures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Instituto de Investigación Marqués de Valdecilla
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects screened for anti-HCV
timeFrame: From march of 2019 to march of 2021
measure: Percentage of anti-HCV positive
timeFrame: From march of 2019 to march of 2021
measure: Number of anti-HCV positive subjects with detectable viremia
timeFrame: From march of 2019 to march of 2021
measure: Percentage of subjects with detectable viremia
timeFrame: From march of 2019 to march of 2021
measure: 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
timeFrame: From march of 2019 to march of 2021
measure: Number of subjects screened for mental illness.
timeFrame: From march of 2019 to march of 2021
measure: Percentage of subjects with mental illness
timeFrame: From march of 2019 to march of 2021
measure: Number of subjects screened for drug addiction
timeFrame: From march of 2019 to march of 2021
measure: Percentage of subjects with drug addiction
timeFrame: From march of 2019 to march of 2021
measure: Number of subjects linked to the Chronicity Program of the Government of Cantabria
timeFrame: From march of 2019 to march of 2021
measure: Percentage of subjects linked to the Chronicity Program of the Government of Cantabria
timeFrame: From march of 2019 to march of 2021
measure: Number of subjects linked to the Extended Bridge program of Penitentiary Institutions
timeFrame: From march of 2019 to march of 2021
measure: Percentage of subjects linked to the Extended Bridge program of Penitentiary Institutions
timeFrame: From march of 2019 to march of 2021
measure: Number of subjects served by the Navigator
timeFrame: From march of 2019 to march of 2021
measure: Number of subjects with an average rating greater than 4 on a Likert scale of 5 points of satisfaction with the Navigator
timeFrame: From march of 2019 to march of 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
Study officials:
References:
citation: 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.
citation: 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.