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

Hepatitis C Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04037046
• Other study ID #: DBS_FOT
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: April 2021
• Source: University of La Laguna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 609
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 50-70 years

• Subjects attending selected primary care centers

• Willing to participate (informed consent signed)

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection

Intervention

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
• 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
• Screening HCV at primary care center
DBS for HCV screening at primary care center

Locations

Country	Name	City	State
Spain	Manuel Hernandez-Guerra, MD	La Laguna	Santa Cruz De Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
University of La Laguna

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Buti M, Domínguez-Hernández R, Casado MÁ, 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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance of the interventions	overall screening rate (number of subjects participating after enrollment)	12 months
Secondary	Feasibility of the intervention measuring quality of spotted cards	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	12 months
Secondary	Subject characteristics associated with participation and feasibility of the different strategies	Demographic characteristics associated with participation and feasibility of the different strategies	12 months
Secondary	Effectiveness of each strategy: rate of HCV positivity	rate of HCV positivity	12 months