Skip to main content
OpenTrials
Completed

NCT Number: NCT04037046

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Virus Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manuel Hernandez-Guerra, MD

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Screening HCV attached onto CCR screening

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

Screening HCV attached onto CCR screening by self-testing

Behavioral

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

Screening HCV at primary care center

Behavioral

DBS for HCV screening at primary care center

Primary outcomes

  1. Acceptance of the interventions

    Time frame: 12 months

    overall screening rate (number of subjects participating after enrollment)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of La Laguna

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2019
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.