Study to Evaluate the Prevalence of Hepatitis C in Spain in 2015 (PREVHEP)

Hepatitis C Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749864
• Other study ID #: JCG-PREVHEP-2015-01
• Status: Completed
• Start date: July 1, 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: September 2018
• Source: Instituto de Investigación Marqués de Valdecilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12246
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta de Hierro-Majadahonda	Madrid
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Clínico Universitario de Valencia	Valencia	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Bruguera M, Forns X. [Hepatitis C in Spain]. Med Clin (Barc). 2006 Jun 17;127(3):113-7. Review. Spanish. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Anti-HCV	Anti-HCV seroprevalence	1 day
Secondary	HCV RNA viral load	Chronic HCV infection	1 day
Secondary	Serum HBsAg	HBV portador status	1 day
Secondary	Birth date	Questionnaire about socio-economic and Health variables	1 day
Secondary	Sex	Questionnaire about socio-economic and Health variables	1 day
Secondary	Nationality	Questionnaire about socio-economic and Health variables	1 day
Secondary	Residence time in Spain	Questionnaire about socio-economic and Health variables	1 day
Secondary	Educational level	Questionnaire about socio-economic and Health variables	1 day
Secondary	Activity and professional qualifications	Questionnaire about socio-economic and Health variables	1 day
Secondary	Lifestyle habit/risk factor score	Questionnaire about socio-economic and Health variables	1 day
Secondary	Nosocomial risk score	Questionnaire about socio-economic and Health variables	1 day
Secondary	History of previous check of HCV/HBV exposure	Questionnaire about socio-economic and Health variables	1 day
Secondary	Sexual behaviour	Questionnarie about socio-economic and Health variables	1 day
Secondary	Number of sexual partners	Questionnaire about socio-economic and Health variables	1 day
Secondary	Weight (kg)	Weight (Anthropometric variables)	1 day
Secondary	Height (cm)	Height (Anthropometric variables)	1 day
Secondary	BMI	Body Mass Index (Anthropometric variables)	1 day
Secondary	Abdominal perimeter (cm)	Abdominal perimeter (Anthropometric variables)	1 day
Secondary	Waist perimeter (cm)	Waist perimeter (Anthropometric variables)	1 day
Secondary	Blood pressure (mmHg)	Blood pressure	1 day
Secondary	ALT	Liver function tests	1 day
Secondary	AST	Liver function tests	1 day
Secondary	Alkaline Phosphatase (AP)	Liver function tests	1 day
Secondary	GGT (Gammaglutamyl transferase)	Liver function tests	1 day
Secondary	Bilirubin	Liver function tests	1 day
Secondary	Serum Albumin	Biochemistry parameters	1 day
Secondary	Total Cholesterol	Biochemistry parameters	1 day
Secondary	LDL Cholesterol	Biochemistry parameters	1 day
Secondary	HDL Cholesterol	Biochemistry parameters	1 day
Secondary	Triglycerides	Biochemistry parameters	1 day
Secondary	White blood cell count (WBC or leukocyte count)	CBC	1 day
Secondary	Hemoglobin	CBC	1 day
Secondary	Platelets	CBC	1 day
Secondary	INR	International Normalized Ratio	1 day
Secondary	kPa in Fibroscan	Liver stiffness	1 day