Integrating Hepatitis C Screening With Dried Blood Spot Testing Into Colorectal Cancer Screening
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional

Summary: 
      The main purpose of the study is to compare the acceptance and viability of three strategies
      aimed to screen hepatitis C virus (HCV) infection in a birth cohort by: a) invitation letter
      offering HCV screening with dried blood spot (DBS) testing at the primary care center, b)
      invitation letter offering both HCV and colorectal cancer (CCR) screening with faecal occult
      test (FOT) at the primary care center, and c) invitation letter offering self-collected
      screening at home for HCV and CCR.
    

Detailed description: 
      This is a prospective, randomized, study in which subjects of four different health areas
      will be invited to participate in three different screening strategies for HCV.

      Hepatologists from a tertiary care hospital and general practitioners from four health areas
      will participate coordinating the study, to first select potential candidates for the study
      (subjects between 50 and 70 years old of the four areas) and secondly, randomize and include
      150 subjects of each area into the three strategies (50 subjects each). The strategies
      include offering by letter screening at the local primary care center for HCV by using dried
      blood spot (DBS) testing, screening for HCV and colorectal cancer (CCR) using faecal occult
      test (FOT) at the primary care center, and self-testing at home-collection with DBS and FOT
      to be performed by the subject and sent by postal office. Subjects will receive an invitation
      and informative letter and will be ask to sign the informed consent to participate.

      In all the planned strategies subjects will be asked to complete a questionnaire that
      includes demographic variables. After two months of sending the letters without response,
      researchers will contact subjects by phone to complete a survey to confirm they received the
      letter and asking for factors of non-participation.

      The hypothesis of the study is that subjects in the risk of having HCV are willing to be
      screened for HCV infection if offered and that the acceptance will be improved if attached to
      CCR screening and even higher if the tests are offered to be self-screened.

      For the present study, a 15% improvement in the participation (acceptance of the screening
      strategy) was hypothesized in the group of patients receiving the strategy 2 (and 3) compared
      to the strategy 1. Taking into account a power of 80%, alpha error of 5% and losses of 20%
      will require 200 patients per group.
    

Intervention name(s): Screening HCV attached onto CCR screening; Screening HCV attached onto CCR screening by self-testing; Screening HCV at primary care center
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Patients assigned to this strategy will receive an invitation letter for HCV screening with DBS and CCR screening with FOT at the primary care center to be performed by the general practitioner; Patients assigned to this strategy will receive an invitation letter for self-testing for HCV screening with DBS, and CCR screening with FOT; DBS for HCV screening at primary care center
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic