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

University of La Laguna

Status: Completed

Conditions: Hepatitis C Virus Infection

Treatments: Behavioral: Screening HCV at primary care center; Behavioral: Screening HCV attached onto CCR screening; Behavioral: Screening HCV attached onto CCR screening by self-testing

Study type: Interventional

Funder types: Other

Identifiers

NCT04037046

DBS_FOT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 609 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 50-70 years
• Subjects attending selected primary care centers
• Willing to participate (informed consent signed)

Exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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609 participants in 3 patient groups

Screening HCV with DBS at primary care centers

Experimental group

Description:

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

Treatment:

Behavioral: Screening HCV at primary care center

Screening HCV and CCR with FOT at primary care centers

Active Comparator group

Description:

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

Treatment:

Behavioral: Screening HCV attached onto CCR screening

Self-testing at home for screening HCV and CCR

Active Comparator group

Description:

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

Treatment:

Behavioral: Screening HCV attached onto CCR screening by self-testing