A Novel Hepatitis c micrOelimination Program in Non imprisonEd SenTenced With Alternative Measures
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Number of subjects screened for anti-HCV
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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 subjects screened for drug addiction
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 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 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
Percentage of subjects with drug addiction
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 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
Number of subjects served by the Navigator
Time Frame: From march of 2019 to march of 2021
Secondary Outcomes
No secondary outcomes reported