Clinical trial NCT02749864: Study to Evaluate the Prevalence of Hepatitis C in Spain in 2015 (PREVHEP)
Official title: Personalized Medicine in HCV Infection. A Prospective, Multicenter, Epidemiological Study to Evaluate the Prevalence of Hepatitis C Infection in Spain in 2015 (PREVHEP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Hepatitis B
Keywords: Hepatitis
Prevalence
Epidemiology
Infectious diseases
Lead sponsor: Instituto de Investigación Marqués de Valdecilla
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 12246
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Serum Anti-HCV
timeFrame: 1 day
Secondary outcomes:
measure: HCV RNA viral load
timeFrame: 1 day
measure: Serum HBsAg
timeFrame: 1 day
measure: Birth date
timeFrame: 1 day
measure: Sex
timeFrame: 1 day
measure: Nationality
timeFrame: 1 day
measure: Residence time in Spain
timeFrame: 1 day
measure: Educational level
timeFrame: 1 day
measure: Activity and professional qualifications
timeFrame: 1 day
measure: Lifestyle habit/risk factor score
timeFrame: 1 day
measure: Nosocomial risk score
timeFrame: 1 day
measure: History of previous check of HCV/HBV exposure
timeFrame: 1 day
measure: Sexual behaviour
timeFrame: 1 day
measure: Number of sexual partners
timeFrame: 1 day
measure: Weight (kg)
timeFrame: 1 day
measure: Height (cm)
timeFrame: 1 day
measure: BMI
timeFrame: 1 day
measure: Abdominal perimeter (cm)
timeFrame: 1 day
measure: Waist perimeter (cm)
timeFrame: 1 day
measure: Blood pressure (mmHg)
timeFrame: 1 day
measure: ALT
timeFrame: 1 day
measure: AST
timeFrame: 1 day
measure: Alkaline Phosphatase (AP)
timeFrame: 1 day
measure: GGT (Gammaglutamyl transferase)
timeFrame: 1 day
measure: Bilirubin
timeFrame: 1 day
measure: Serum Albumin
timeFrame: 1 day
measure: Total Cholesterol
timeFrame: 1 day
measure: LDL Cholesterol
timeFrame: 1 day
measure: HDL Cholesterol
timeFrame: 1 day
measure: Triglycerides
timeFrame: 1 day
measure: White blood cell count (WBC or leukocyte count)
timeFrame: 1 day
measure: Hemoglobin
timeFrame: 1 day
measure: Platelets
timeFrame: 1 day
measure: INR
timeFrame: 1 day
measure: kPa in Fibroscan
timeFrame: 1 day
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro-Majadahonda
Study officials:
affiliation: Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla. Professor at the Universidad de Cantabria
name: Javier Crespo García, MDPhD
role: STUDY_DIRECTOR
affiliation: Head of Gastroenterology and Hepatology at Hospital Universitario Puerta de Hierro-Majadahonda
name: Jose L Calleja, MDPhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gastroenterology and Hepatology Department at Hospital Clínico U. de Valencia
name: Miguel A Serra, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruguera M, Forns X. [Hepatitis C in Spain]. Med Clin (Barc). 2006 Jun 17;127(3):113-7. doi: 10.1157/13090276. Spanish.
citation: 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.
citation: 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.
citation: 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.