Study to Evaluate the Prevalence of Hepatitis C in Spain in 2015 (PREVHEP)
NCT ID: NCT02749864
Last Updated: 2018-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12246 participants
OBSERVATIONAL
2015-07-01
2017-04-01
Brief Summary
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Aim: To determine the prevalence of seropositivity and chronic infection with the HCV and to analyze the associated factors. To analyze and infer different screening strategies for HCV infection based on the at-risk groups/cohorts of elevated prevalence detected. to assess the efficiency of screening strategies and the subsequent cost-effectiveness of treatment in the general population
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Detailed Description
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Patients and sampling: The study population has been distributed in groups according to age (20-34; 35-49; 50-74 years) and sex. In order to select a representative sample of this overall population, three Spanish regions will be selected on the basis of their different HCV-related hospitalisation rates defined as follows: high, \>120 cases/100,000 inhabitants (Madrid); medium, 90-119 cases/100,000 inhabitants (Cantabria); or low, \<90 cases/100,000 inhabitants (Valencia).
The participants will be selected through a random, representative sample using our two-stage conglomerate sampling with stratification of the First-Stage Units. These FSUs are made up by the Basic Health Areas (Health Centers). The Second-Stage Units are made up by the individuals. The stratification criteria used in the first stage will be the socioeconomic status-rural/urban environment. The selection of sample elements will be carried out through simple random sampling from the healthcare card database pertaining to the selected Health Centers. A sequence of random, computer-generated numbers will be obtained.
Sample size: In order to achieve an accuracy of 0.4% in the estimate of a percentage through a two-tailed 95% confidence interval, assuming the prevalences indicated by age strata in the general Spanish population (0.6%, 1.9% and 2.7% respectively), a total of 12,263 subjects distributed as follows: 1,456 aged 20-34 years, 4,476 aged 35-49 years and 6,331 aged 50-74 years.
Anticipating an uptake of 9-15%,21 following invitation via telephone, between 81,753 and 136,255 subjects distributed over the three regions needed to be contacted at random.
Recruitment method for randomized patients. Selected subjects will be called by phone by trained personnel. The subject will be invited to report for an interview in order to carry out a socio-healthcare questionnaire, a physical examination, and an analytical test. In the event the patient refuses to participate, permission shall be requested to collect minimum anonymous data for the subsequent study of possible screening biases. Patients meeting inclusion criteria and provide written informed consent to be included in the study.
Variables in the study: socio-healthcare questionnaire includes variables such as age, sex, socioeconomic status, risk factors, health habits, etc. Analytical variables (blood count, biochemistry, serologies for HBV and HCV, etc.) are collected. A Fibroscan is also performed. A cost-effectiveness of screening strategies and treatment will be analysed using a Markov model
Full duration: 21 months
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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A: Age 20-34 yr
No intervention Cohort of subjects aged 20-34 years old.
No interventions assigned to this group
B: Age 35-49 yr
No intervention Cohort of subjects aged 35-49 years old.
No interventions assigned to this group
C: Age 50-79 yr
No intervention Cohort of subjects aged 50-79 years old.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* They agree to participate, understand and give informed consent.
Exclusion Criteria
20 Years
74 Years
ALL
No
Sponsors
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Instituto de Investigación Marqués de Valdecilla
OTHER
Responsible Party
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Principal Investigators
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Javier Crespo García, MDPhD
Role: STUDY_DIRECTOR
Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla. Professor at the Universidad de Cantabria
Jose L Calleja, MDPhD
Role: PRINCIPAL_INVESTIGATOR
Head of Gastroenterology and Hepatology at Hospital Universitario Puerta de Hierro-Majadahonda
Miguel A Serra, MDPhD
Role: PRINCIPAL_INVESTIGATOR
Gastroenterology and Hepatology Department at Hospital Clínico U. de Valencia
Locations
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Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Hospital Universitario Puerta de Hierro-Majadahonda
Madrid, , Spain
Countries
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References
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Bruguera M, Forns X. [Hepatitis C in Spain]. Med Clin (Barc). 2006 Jun 17;127(3):113-7. doi: 10.1157/13090276. Spanish.
Ditah I, Ditah F, Devaki P, Ewelukwa O, Ditah C, Njei B, Luma HN, Charlton M. The changing epidemiology of hepatitis C virus infection in the United States: National Health and Nutrition Examination Survey 2001 through 2010. J Hepatol. 2014 Apr;60(4):691-8. doi: 10.1016/j.jhep.2013.11.014. Epub 2013 Nov 27.
McGarry LJ, Pawar VS, Panchmatia HR, Rubin JL, Davis GL, Younossi ZM, Capretta JC, O'Grady MJ, Weinstein MC. Economic model of a birth cohort screening program for hepatitis C virus. Hepatology. 2012 May;55(5):1344-55. doi: 10.1002/hep.25510. Epub 2012 Mar 18.
Ezcurra I, Puente A, Cuadrado A, Tamayo I, Iruzubieta P, Arias-Loste MT, Gonzalez FJ, Pellon R, Sanchez S, Crespo J, Acebo M, Lopez-Hoyos M, Perez R, Cuesta A, Anton A, Echavarria V, Fabrega E, Crespo J, Fortea JI. No evidence of association between inherited thrombophilia and increased risk of liver fibrosis. United European Gastroenterol J. 2023 Dec;11(10):1010-1020. doi: 10.1002/ueg2.12500. Epub 2023 Nov 28.
Llop E, Iruzubieta P, Perello C, Fernandez Carrillo C, Cabezas J, Escudero MD, Gonzalez M, Hernandez Conde M, Puchades L, Arias-Loste MT, Serra MA, Crespo J, Calleja JL. High liver stiffness values by transient elastography related to metabolic syndrome and harmful alcohol use in a large Spanish cohort. United European Gastroenterol J. 2021 Oct;9(8):892-902. doi: 10.1002/ueg2.12109. Epub 2021 Jun 2.
Other Identifiers
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JCG-PREVHEP-2015-01
Identifier Type: -
Identifier Source: org_study_id
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