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出境医 / 临床实验 / A Novel Hepatitis c micrOelimination Program in Non imprisonEd SenTenced With Alternative Measures (HONEST)

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

Study Description
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.

Condition or disease Intervention/treatment
Hepatotropic Virus Infection Addictive Behaviours o Conducts Mental Disease People Sentenced to Non-custodial Sentences Other: Observational study

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Novel Hepatitis c micrOelimination Program in Non imprisonEd SenTenced With Alternative Measures
Estimated Study Start Date : May 10, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 31, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
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
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.
Outcome Measures
Primary Outcome Measures :
  1. Number of subjects screened for anti-HCV [ Time Frame: From march of 2019 to march of 2021 ]
  2. Percentage of anti-HCV positive [ Time Frame: From march of 2019 to march of 2021 ]
  3. Number of anti-HCV positive subjects with detectable viremia [ Time Frame: From march of 2019 to march of 2021 ]
  4. Percentage of subjects with detectable viremia [ Time Frame: From march of 2019 to march of 2021 ]
  5. 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 ]
  6. Number of subjects screened for mental illness. [ Time Frame: From march of 2019 to march of 2021 ]
  7. Percentage of subjects with mental illness [ Time Frame: From march of 2019 to march of 2021 ]
  8. Number of subjects screened for drug addiction [ Time Frame: From march of 2019 to march of 2021 ]
  9. Percentage of subjects with drug addiction [ Time Frame: From march of 2019 to march of 2021 ]
  10. Number of subjects linked to the Chronicity Program of the Government of Cantabria [ Time Frame: From march of 2019 to march of 2021 ]
  11. Percentage of subjects linked to the Chronicity Program of the Government of Cantabria [ Time Frame: From march of 2019 to march of 2021 ]
  12. Number of subjects linked to the Extended Bridge program of Penitentiary Institutions [ Time Frame: From march of 2019 to march of 2021 ]
  13. Percentage of subjects linked to the Extended Bridge program of Penitentiary Institutions [ Time Frame: From march of 2019 to march of 2021 ]
  14. Number of subjects served by the Navigator [ Time Frame: From march of 2019 to march of 2021 ]
  15. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Antonio Cuadrado Lavín, MD 942202544 antonio.cuadrado@scsalud.es
Contact: Lucía Lavín Alconero, Bsc,PhD 942203373 eclinicos5@idival.org

Locations
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Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Contact: Antonio Cuadrado Lavín, MD    942202544    antonio.cuadrado@scsalud.es   
Sponsors and Collaborators
Instituto de Investigación Marqués de Valdecilla
Tracking Information
First Submitted Date April 23, 2019
First Posted Date April 30, 2019
Last Update Posted Date April 30, 2019
Estimated Study Start Date May 10, 2019
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2019)
  • 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 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 screened for drug addiction [ 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 ]
  • Number of subjects linked to the Chronicity Program of the Government of Cantabria [ 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 Extended Bridge program of Penitentiary Institutions [ 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 subjects served by the Navigator [ 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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Hepatotropic Virus Infection
  • Addictive Behaviours o Conducts
  • Mental Disease
  • People Sentenced to Non-custodial Sentences
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.
Study Groups/Cohorts 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).
Intervention: Other: Observational study
Publications *
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 29, 2019) 		1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03932396
Other Study ID Numbers HONEST
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Instituto de Investigación Marqués de Valdecilla
Study Sponsor Instituto de Investigación Marqués de Valdecilla
Collaborators Not Provided
Investigators Not Provided
PRS Account Instituto de Investigación Marqués de Valdecilla
Verification Date April 2019

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