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

Sponsor

University of La Laguna (Other)

Overall Status

Completed

CT.gov ID

NCT04037046

Collaborator

(none)

609

Enrollment

Location

Arms

Actual Duration (Months)

75.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Infection	Behavioral: Screening HCV attached onto CCR screening Behavioral: Screening HCV attached onto CCR screening by self-testing Behavioral: Screening HCV at primary care center	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

609 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Behavioral: Screening HCV at primary care center DBS for HCV screening at primary care center
Active Comparator: 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	Behavioral: 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
Active Comparator: 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	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

Arm

Intervention/Treatment

Experimental: 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

Behavioral: Screening HCV at primary care center

DBS for HCV screening at primary care center

Active Comparator: 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

Behavioral: 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

Active Comparator: 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

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

Outcome Measures

Primary Outcome Measures

Acceptance of the interventions [12 months]
overall screening rate (number of subjects participating after enrollment)

Secondary Outcome Measures

Feasibility of the intervention measuring quality of spotted cards [12 months]
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
Subject characteristics associated with participation and feasibility of the different strategies [12 months]
Demographic characteristics associated with participation and feasibility of the different strategies
Effectiveness of each strategy: rate of HCV positivity [12 months]
rate of HCV positivity

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manuel Hernandez-Guerra, MD	La Laguna	Santa Cruz De Tenerife	Spain	38320

Sponsors and Collaborators

University of La Laguna

Investigators

Principal Investigator: Manuel Hernandez-Guerra, MD, MD

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Manuel Hernandez-Guerra, MD, Principal Investigator, University of La Laguna

ClinicalTrials.gov Identifier:

NCT04037046

Other Study ID Numbers:

DBS_FOT

First Posted:

Jul 30, 2019

Last Update Posted:

Apr 30, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatitis A

Hepatitis C

Hepatitis

Study Results

No Results Posted as of Apr 30, 2021