Study to Evaluate the Prevalence of Hepatitis C in Spain in 2015 (PREVHEP) (PREVHEP)
Personalized Medicine in HCV Infection. A Prospective, Multicenter, Epidemiological Study to Evaluate the Prevalence of Hepatitis C Infection in Spain in 2015 (PREVHEP)
The hypothesis of this investigation stresses that the current understanding of the prevalence of HCV infection in the general population and in different subgroups will serve to lay out medium- and long-term measures for action geared toward reducing the disease burden through preventive, research, screening and therapeutic measures.
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
研究概览
详细说明
Design of the study: Seroepidemiological and virological study of cross-sectional population-based.
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
研究类型
注册 (实际的)
联系人和位置
学习地点
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Madrid、西班牙、28222
- Hospital Universitario Puerta de Hierro-Majadahonda
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Cantabria
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Santander、Cantabria、西班牙、39008
- Hospital Universitario Marqués de Valdecilla
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Comunidad Valenciana
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Valencia、Comunidad Valenciana、西班牙
- Hospital Clinico Universitario de Valencia
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
General population aged 20-74 years who agree to participate when contacted by phone call after a two-stage conglomerate sampling with stratification of the First-Stage Units.
The study will be carried out in three Autonomous Communities (regions) in Spain.
描述
Inclusion Criteria:
- Patients between 20 and 74 who have health card in each of the autonomous communities studied.
- They agree to participate, understand and give informed consent.
Exclusion Criteria:
- Do not meet the criteria above.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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A: Age 20-34 yr
No intervention Cohort of subjects aged 20-34 years old.
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B: Age 35-49 yr
No intervention Cohort of subjects aged 35-49 years old.
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C: Age 50-79 yr
No intervention Cohort of subjects aged 50-79 years old.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Serum Anti-HCV
大体时间:1 day
|
Anti-HCV seroprevalence
|
1 day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
HCV RNA viral load
大体时间:1 day
|
Chronic HCV infection
|
1 day
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Serum HBsAg
大体时间:1 day
|
HBV portador status
|
1 day
|
Birth date
大体时间:1 day
|
Questionnaire about socio-economic and Health variables
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1 day
|
Sex
大体时间:1 day
|
Questionnaire about socio-economic and Health variables
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1 day
|
Nationality
大体时间:1 day
|
Questionnaire about socio-economic and Health variables
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1 day
|
Residence time in Spain
大体时间:1 day
|
Questionnaire about socio-economic and Health variables
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1 day
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Educational level
大体时间:1 day
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Questionnaire about socio-economic and Health variables
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1 day
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Activity and professional qualifications
大体时间:1 day
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Questionnaire about socio-economic and Health variables
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1 day
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Lifestyle habit/risk factor score
大体时间:1 day
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Questionnaire about socio-economic and Health variables
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1 day
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Nosocomial risk score
大体时间:1 day
|
Questionnaire about socio-economic and Health variables
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1 day
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History of previous check of HCV/HBV exposure
大体时间:1 day
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Questionnaire about socio-economic and Health variables
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1 day
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Sexual behaviour
大体时间:1 day
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Questionnarie about socio-economic and Health variables
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1 day
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Number of sexual partners
大体时间:1 day
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Questionnaire about socio-economic and Health variables
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1 day
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Weight (kg)
大体时间:1 day
|
Weight (Anthropometric variables)
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1 day
|
Height (cm)
大体时间:1 day
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Height (Anthropometric variables)
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1 day
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BMI
大体时间:1 day
|
Body Mass Index (Anthropometric variables)
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1 day
|
Abdominal perimeter (cm)
大体时间:1 day
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Abdominal perimeter (Anthropometric variables)
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1 day
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Waist perimeter (cm)
大体时间:1 day
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Waist perimeter (Anthropometric variables)
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1 day
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Blood pressure (mmHg)
大体时间:1 day
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Blood pressure
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1 day
|
ALT
大体时间:1 day
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Liver function tests
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1 day
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AST
大体时间:1 day
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Liver function tests
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1 day
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Alkaline Phosphatase (AP)
大体时间:1 day
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Liver function tests
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1 day
|
GGT (Gammaglutamyl transferase)
大体时间:1 day
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Liver function tests
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1 day
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Bilirubin
大体时间:1 day
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Liver function tests
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1 day
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Serum Albumin
大体时间:1 day
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Biochemistry parameters
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1 day
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Total Cholesterol
大体时间:1 day
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Biochemistry parameters
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1 day
|
LDL Cholesterol
大体时间:1 day
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Biochemistry parameters
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1 day
|
HDL Cholesterol
大体时间:1 day
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Biochemistry parameters
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1 day
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Triglycerides
大体时间:1 day
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Biochemistry parameters
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1 day
|
White blood cell count (WBC or leukocyte count)
大体时间:1 day
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CBC
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1 day
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Hemoglobin
大体时间:1 day
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CBC
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1 day
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Platelets
大体时间:1 day
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CBC
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1 day
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INR
大体时间:1 day
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International Normalized Ratio
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1 day
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kPa in Fibroscan
大体时间:1 day
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Liver stiffness
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1 day
|
合作者和调查者
调查人员
- 研究主任:Javier Crespo García, MDPhD、Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla. Professor at the Universidad de Cantabria
- 首席研究员:Jose L Calleja, MDPhD、Head of Gastroenterology and Hepatology at Hospital Universitario Puerta de Hierro-Majadahonda
- 首席研究员:Miguel A Serra, MDPhD、Gastroenterology and Hepatology Department at Hospital Clínico U. de Valencia
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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