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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||609 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Acceptance of the interventions [ Time Frame: 12 months ]overall screening rate (number of subjects participating after enrollment)
- 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
- 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
- Effectiveness of each strategy: rate of HCV positivity [ Time Frame: 12 months ]rate of HCV positivity
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
|Contact: Manuel Hernandez-Guerra, MDfirstname.lastname@example.org|
|Manuel Hernandez-Guerra, MD||Recruiting|
|La Laguna, Santa Cruz De Tenerife, Spain, 38320|
|Contact: Manuel Hernandez-Guerra, MD 34922678559 email@example.com|
|Principal Investigator:||Manuel Hernandez-Guerra, MD||MD|