Hepatotropic Virus InfectionHONESTNCT03932396
A Novel Hepatitis c micrOelimination Program in Non imprisonEd SenTenced With Alternative Measures
An observational study of Hepatotropic Virus Infection and Addictive Behaviours o Conducts, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hepatotropic Virus Infection, Addictive Behaviours o Conducts, Mental Disease
- What is being tested?
- Observational study
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2019to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- they are not willing to participate and do not sign informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Antonio Cuadrado Lavín, MD, 942202544, antonio.cuadrado@scsalud.es
About this study
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.
- Conditions
- Hepatotropic Virus Infection, Addictive Behaviours o Conducts, Mental Disease, People Sentenced to Non-custodial Sentences
- Being tested
- Observational study
- Keywords
- hepatitis C virus, non-custodial sentences, addictive behaviours, Mental disease, Navigator, screening, POCT
- Medical subject headings
- Mental Disorders, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects screened for anti-HCV
Measured: From march of 2019 to march of 2021
Percentage of anti-HCV positive
Measured: From march of 2019 to march of 2021
Number of anti-HCV positive subjects with detectable viremia
Measured: From march of 2019 to march of 2021
Percentage of subjects with detectable viremia
Measured: 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
Measured: From march of 2019 to march of 2021
Number of subjects screened for mental illness.
Measured: From march of 2019 to march of 2021
Percentage of subjects with mental illness
Measured: From march of 2019 to march of 2021
Number of subjects screened for drug addiction
Measured: From march of 2019 to march of 2021
Percentage of subjects with drug addiction
Measured: From march of 2019 to march of 2021
Number of subjects linked to the Chronicity Program of the Government of Cantabria
Measured: From march of 2019 to march of 2021
Percentage of subjects linked to the Chronicity Program of the Government of Cantabria
Measured: From march of 2019 to march of 2021
Number of subjects linked to the Extended Bridge program of Penitentiary Institutions
Measured: From march of 2019 to march of 2021
Percentage of subjects linked to the Extended Bridge program of Penitentiary Institutions
Measured: From march of 2019 to march of 2021
Number of subjects served by the Navigator
Measured: 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
Measured: From march of 2019 to march of 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start10 May 2019 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatotropic Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932396
- Sponsor's protocol ID
- HONEST
- Acronym
- HONEST
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29946175Blachier 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.
PubMed 23419824
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Hepatitis c micrOelimination Program in Non imprisonEd SenTenced With Alternative Measures
- ClinicalTrials.gov ID
- NCT03932396
- Acronym / sponsor ID
- HONEST / HONEST
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 10 May 2019 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group of subjects who fulfill the inclusion criteria | – | Other: Observational studyAll 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). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- they are not willing to participate and do not sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyNo 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. | Other | Single group of subjects who fulfill the inclusion criteria |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Background: PubMed 29946175Cuadrado 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.
- Results publication: PubMed 23419824Blachier 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatotropic Virus Infection and Addictive Behaviours o Conducts, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Cuadrado Lavín, MD (942202544, antonio.cuadrado@scsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects screened for anti-HCV (time frame: From march of 2019 to march of 2021). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03932396, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.