Integrating Hepatitis C Screening With Dried Blood Spot Testing Into Colorectal Cancer Screening

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Trial to Evaluate the Acceptance and Viability of Three Strategies in Birth Cohort Hepatitis C Screening

Conditions
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Hepatitis C Virus Infection

Intervention / Treatment
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* Behavioral: Screening HCV attached onto CCR screening
* Behavioral: Screening HCV attached onto CCR screening by self-testing
* Behavioral: Screening HCV at primary care center


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50-70 years Subjects attending selected primary care centers Willing to participate (informed consent signed) Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening HCV with DBS at primary care centers<br>Patients assigned to the strategy 1 will receive an invitation letter for HCV screening with DBS at the primary care center to be performed by the general practitioner | Behavioral: Screening HCV at primary care center<br>* DBS for HCV screening at primary care center<br>|
| Active Comparator: Screening HCV and CCR with FOT at primary care centers<br>Patients assigned to the strategy 2 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 | Behavioral: Screening HCV attached onto CCR screening<br>* 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<br>|
| Active Comparator: Self-testing at home for screening HCV and CCR<br>Patients assigned to the strategy 3 will receive an invitation letter for self-testing at home for HCV screening with DBS, and CCR screening with FOT | Behavioral: Screening HCV attached onto CCR screening by self-testing<br>* Patients assigned to this strategy will receive an invitation letter for self-testing for HCV screening with DBS, and CCR screening with FOT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of the interventions | overall screening rate (number of subjects participating after enrollment) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the intervention measuring quality of spotted cards | the validity of specimens (defined as enough blood sample to fill at least one spot in the card) of DBS tests performed at primary care centers and by self-testing at home | 12 months | 
| Subject characteristics associated with participation and feasibility of the different strategies | Demographic characteristics associated with participation and feasibility of the different strategies | 12 months | 
| Effectiveness of each strategy: rate of HCV positivity | rate of HCV positivity | 12 months |