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

NCT ID: NCT04037046

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 609 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-11-01

Brief 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.

Conditions

Hepatitis C Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Screening HCV with DBS at primary care centers

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

Group Type: EXPERIMENTAL

Screening HCV at primary care center

Intervention Type: BEHAVIORAL

DBS for HCV screening at primary care center

Screening HCV and CCR with FOT at primary care centers

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

Group Type: ACTIVE_COMPARATOR

Screening HCV attached onto CCR screening

Intervention Type: BEHAVIORAL

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

Self-testing at home for screening HCV and CCR

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

Group Type: ACTIVE_COMPARATOR

Screening HCV attached onto CCR screening by self-testing

Intervention Type: BEHAVIORAL

Patients assigned to this strategy will receive an invitation letter for self-testing for HCV screening with DBS, and CCR screening with FOT

Interventions

Screening HCV attached onto CCR screening

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

Intervention Type: BEHAVIORAL

Screening HCV attached onto CCR screening by self-testing

Patients assigned to this strategy will receive an invitation letter for self-testing for HCV screening with DBS, and CCR screening with FOT

Intervention Type: BEHAVIORAL

Screening HCV at primary care center

DBS for HCV screening at primary care center

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of La Laguna

OTHER

Sponsor Role: lead

Responsible Party

Manuel Hernandez-Guerra, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manuel Hernandez-Guerra, MD

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

Manuel Hernandez-Guerra, MD

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Countries

Spain

References

Buti M, Dominguez-Hernandez R, Casado MA, Sabater E, Esteban R. Healthcare value of implementing hepatitis C screening in the adult general population in Spain. PLoS One. 2018 Nov 28;13(11):e0208036. doi: 10.1371/journal.pone.0208036. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30485377 (View on PubMed)

Zuure FR, Urbanus AT, Langendam MW, Helsper CW, van den Berg CH, Davidovich U, Prins M. Outcomes of hepatitis C screening programs targeted at risk groups hidden in the general population: a systematic review. BMC Public Health. 2014 Jan 22;14:66. doi: 10.1186/1471-2458-14-66.

Reference Type: BACKGROUND

PMID: 24450797 (View on PubMed)

Tuaillon E, Mondain AM, Meroueh F, Ottomani L, Picot MC, Nagot N, Van de Perre P, Ducos J. Dried blood spot for hepatitis C virus serology and molecular testing. Hepatology. 2010 Mar;51(3):752-8. doi: 10.1002/hep.23407.

Reference Type: BACKGROUND

PMID: 20043287 (View on PubMed)

Other Identifiers

DBS_FOT

Identifier Type: -

Identifier Source: org_study_id