An observational study in Hepatitis C and Hepatitis B, sponsored by Instituto de Investigación Marqués de Valdecilla. Completed at 3 sites in Spain. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2018-09-26.
Sponsored by Instituto de Investigación Marqués de Valdecilla · Observational
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
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
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 12,246 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Instituto de Investigación Marqués de Valdecilla is the lead sponsor of 32 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
No intervention Cohort of subjects aged 20-34 years old.
No intervention Cohort of subjects aged 35-49 years old.
No intervention Cohort of subjects aged 50-79 years old.
Serum Anti-HCV
Anti-HCV seroprevalence
Time frame: 1 day
HCV RNA viral load
Chronic HCV infection
Time frame: 1 day
Serum HBsAg
HBV portador status
Time frame: 1 day
Birth date
Questionnaire about socio-economic and Health variables
Time frame: 1 day
Sex
Questionnaire about socio-economic and Health variables
Time frame: 1 day
Nationality
Questionnaire about socio-economic and Health variables
Time frame: 1 day
Residence time in Spain
Questionnaire about socio-economic and Health variables
Time frame: 1 day
Educational level
Questionnaire about socio-economic and Health variables
Time frame: 1 day
Activity and professional qualifications
Questionnaire about socio-economic and Health variables
Time frame: 1 day
Lifestyle habit/risk factor score
Questionnaire about socio-economic and Health variables
Time frame: 1 day
Nosocomial risk score
Questionnaire about socio-economic and Health variables
Time frame: 1 day
History of previous check of HCV/HBV exposure
Questionnaire about socio-economic and Health variables
Time frame: 1 day
Sexual behaviour
Questionnarie about socio-economic and Health variables
Time frame: 1 day
Number of sexual partners
Questionnaire about socio-economic and Health variables
Time frame: 1 day
Weight (kg)
Weight (Anthropometric variables)
Time frame: 1 day
Height (cm)
Height (Anthropometric variables)
Time frame: 1 day
BMI
Body Mass Index (Anthropometric variables)
Time frame: 1 day
Abdominal perimeter (cm)
Abdominal perimeter (Anthropometric variables)
Time frame: 1 day
Waist perimeter (cm)
Waist perimeter (Anthropometric variables)
Time frame: 1 day
Blood pressure (mmHg)
Blood pressure
Time frame: 1 day
ALT
Liver function tests
Time frame: 1 day
AST
Liver function tests
Time frame: 1 day
Alkaline Phosphatase (AP)
Liver function tests
Time frame: 1 day
GGT (Gammaglutamyl transferase)
Liver function tests
Time frame: 1 day
Bilirubin
Liver function tests
Time frame: 1 day
Serum Albumin
Biochemistry parameters
Time frame: 1 day
Total Cholesterol
Biochemistry parameters
Time frame: 1 day
LDL Cholesterol
Biochemistry parameters
Time frame: 1 day
HDL Cholesterol
Biochemistry parameters
Time frame: 1 day
Triglycerides
Biochemistry parameters
Time frame: 1 day
White blood cell count (WBC or leukocyte count)
CBC
Time frame: 1 day
Hemoglobin
CBC
Time frame: 1 day
Platelets
CBC
Time frame: 1 day
INR
International Normalized Ratio
Time frame: 1 day
kPa in Fibroscan
Liver stiffness
Time frame: 1 day
Plan to share: No
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Instituto de Investigación Marqués de Valdecilla