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

NCT04037046 | Completed

• 1 other identifier: DBS_FOT
• Study Type: interventional
• Target: 609
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (1)

• Acceptance of the interventions

  overall screening rate (number of subjects participating after enrollment)

  12 months

Secondary Outcomes (3)

• Feasibility of the intervention measuring quality of spotted cards

  12 months

• Subject characteristics associated with participation and feasibility of the different strategies

  12 months

• Effectiveness of each strategy: rate of HCV positivity

  12 months

Study Arms (3)

Screening HCV with DBS at primary care centers

EXPERIMENTAL

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

Screening HCV and CCR with FOT at primary care centers

ACTIVE COMPARATOR

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

Self-testing at home for screening HCV and CCR

ACTIVE COMPARATOR

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

Interventions

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 and CCR with FOT at primary care centers

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

Self-testing at home for screening HCV and CCR

Screening HCV at primary care center BEHAVIORAL

DBS for HCV screening at primary care center

Screening HCV with DBS at primary care centers

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of La Laguna: lead

Study Sites (1)

Manuel Hernandez-Guerra, MD

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

Location

Related Publications (3)

• 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.

  PMID: 30485377 BACKGROUND

• 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.

  PMID: 24450797 BACKGROUND

• 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.

  PMID: 20043287 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Officials

• Manuel Hernandez-Guerra, MD

  MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 30, 2019
• Study Start: March 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)