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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03932396
Acronym
HONEST
Enrollment
1000
Registered
2019-04-30
Start date
2019-05-10
Completion date
2021-03-31
Last updated
2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

OTHERObservational 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.

Sponsors

Instituto de Investigación Marqués de Valdecilla
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of subjects screened for drug addictionFrom march of 2019 to march of 2021
Percentage of subjects with drug addictionFrom march of 2019 to march of 2021
Number of subjects screened for anti-HCVFrom march of 2019 to march of 2021
Percentage of anti-HCV positiveFrom march of 2019 to march of 2021
Number of anti-HCV positive subjects with detectable viremiaFrom march of 2019 to march of 2021
Percentage of subjects with detectable viremiaFrom 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 andFrom 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 illnessFrom march of 2019 to march of 2021
Number of subjects linked to the Chronicity Program of the Government of CantabriaFrom march of 2019 to march of 2021
Percentage of subjects linked to the Chronicity Program of the Government of CantabriaFrom march of 2019 to march of 2021
Number of subjects linked to the Extended Bridge program of Penitentiary InstitutionsFrom march of 2019 to march of 2021
Percentage of subjects linked to the Extended Bridge program of Penitentiary InstitutionsFrom march of 2019 to march of 2021
Number of subjects served by the NavigatorFrom 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 NavigatorFrom march of 2019 to march of 2021

Countries

Spain

Contacts

Primary ContactAntonio Cuadrado Lavín, MD
antonio.cuadrado@scsalud.es942202544
Backup ContactLucía Lavín Alconero, Bsc,PhD
eclinicos5@idival.org942203373

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026