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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04037046
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Manuel Hernandez-Guerra, MD, University of La Laguna

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 609 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel 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 : March 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Acceptance of the interventions [ Time Frame: 12 months ]
    overall screening rate (number of subjects participating after enrollment)


Secondary Outcome Measures :
  1. Feasibility of the intervention measuring quality of spotted cards [ Time Frame: 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

  2. Subject characteristics associated with participation and feasibility of the different strategies [ Time Frame: 12 months ]
    Demographic characteristics associated with participation and feasibility of the different strategies

  3. Effectiveness of each strategy: rate of HCV positivity [ Time Frame: 12 months ]
    rate of HCV positivity



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037046


Contacts
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Contact: Manuel Hernandez-Guerra, MD 34922678559 mhernand@ull.edu.es

Locations
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Spain
Manuel Hernandez-Guerra, MD Recruiting
La Laguna, Santa Cruz De Tenerife, Spain, 38320
Contact: Manuel Hernandez-Guerra, MD    34922678559    mhernand@ull.edu.es   
Sponsors and Collaborators
University of La Laguna
Investigators
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Principal Investigator: Manuel Hernandez-Guerra, MD MD
Publications:
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Responsible Party: Manuel Hernandez-Guerra, MD, Principal Investigator, University of La Laguna
ClinicalTrials.gov Identifier: NCT04037046    
Other Study ID Numbers: DBS_FOT
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections