An interventional study of Screening HCV attached onto CCR screening and Screening HCV attached onto CCR screening by self-testing in Hepatitis C Virus Infection, sponsored by University of La Laguna. Completed at 1 site in Spain. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by University of La Laguna · Not applicable, Interventional, and Diagnostic
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 609 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →University of La Laguna is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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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
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 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 HCV screening with DBS and CCR screening with FOT at the primary care center to be performed by the general practitioner
Patients assigned to this strategy will receive an invitation letter for self-testing for HCV screening with DBS, and CCR screening with FOT
DBS for HCV screening at primary care center
Acceptance of the interventions
overall screening rate (number of subjects participating after enrollment)
Time frame: 12 months
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
Time frame: 12 months
Subject characteristics associated with participation and feasibility of the different strategies
Demographic characteristics associated with participation and feasibility of the different strategies
Time frame: 12 months
Effectiveness of each strategy: rate of HCV positivity
rate of HCV positivity
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of La Laguna