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Acceptance of Hepatitis C Screening by Self-testing in High Risk and General Population

Primary Purpose

Hepatitis C

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Screening HCV. HR-HOSPITAL
Screening HCV. HR-DDP
Screening HCV. GP-HOSPITAL
Screening HCV. GP-PCC
Sponsored by
University of La Laguna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis C

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • All subjects who have contacted a drug dependence center between 2013 and 2017, as well as patients from a group of a primary care center.
  • Signed informed consent.

Exclusion criteria:

  • Patient's refusal to participate in the study.
  • Negative HCV serology or viral load in the last year.
  • Death.
  • Belonging to another health area
  • Not having the patient's address in the hospital's computer system.

Sites / Locations

  • Complejo Hospitalario Universitario de CanariasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

HR-HOSPITAL

HR-DDP

GP-HOSPITAL

GP-PCC

Arm Description

Patients assigned to the strategy HR-HOSPITAL, who are high risk population (HR), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the referral hospital.

Patients assigned to the strategy HR-DDP, who are high risk population, will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the drug dependence center (DDP) the participants used to attend.

Patients assigned to the strategy GP-HOSPITAL, who are general population (GP), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the referral hospital.

Patients assigned to the strategy GP-PCC, who are general population (GP), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the primary care center (PCC) to be performed by the general practitioner.

Outcomes

Primary Outcome Measures

Acceptance of the intervention
Overall screening rate

Secondary Outcome Measures

Viability
The investigators will measure and report the amount of DBS received from the participants, taking into account the group to which the participants belong.
Participation
Number of participants by sending their DBS and different possible factors associated to a higher rate of participation.

Full Information

First Posted
October 25, 2021
Last Updated
May 8, 2023
Sponsor
University of La Laguna
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1. Study Identification

Unique Protocol Identification Number
NCT05146609
Brief Title
Acceptance of Hepatitis C Screening by Self-testing in High Risk and General Population
Official Title
Acceptance of Hepatitis C Screening by Self-testing in High Risk and General Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of La Laguna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing assisted by center of origin or referral hospital, as a strategy for screening for hepatitis C virus (HCV) in high risk population (ex-users of drug dependence centers) compared to the general population assisted by primary care centers.
Detailed Description
This is a randomized clinical trial involving patients who between 2013 and 2017 have contacted the drug dependence center and patients from general population. After selecting those who do not meet any exclusion criteria, a letter will be sent to them inviting them to participate in this study. This letter will contain the study information sheet and informed consent, and a self-testing kit with an explanatory leaflet so that each person can carry out the test in a simple and easy way. The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing, to study whether support improves participation and to identify predictors of participation. For the present study, assuming an increase of 18% participation (from 18% to 28% offering support by the patient's referral center, and based on a previous study in our environment of self-testing in the general population), taking into account a power of 80%, alpha error of 5%, and losses of 20%, will require 346 patients per group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HR-HOSPITAL
Arm Type
Experimental
Arm Description
Patients assigned to the strategy HR-HOSPITAL, who are high risk population (HR), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the referral hospital.
Arm Title
HR-DDP
Arm Type
Experimental
Arm Description
Patients assigned to the strategy HR-DDP, who are high risk population, will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the drug dependence center (DDP) the participants used to attend.
Arm Title
GP-HOSPITAL
Arm Type
Experimental
Arm Description
Patients assigned to the strategy GP-HOSPITAL, who are general population (GP), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the referral hospital.
Arm Title
GP-PCC
Arm Type
Experimental
Arm Description
Patients assigned to the strategy GP-PCC, who are general population (GP), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the primary care center (PCC) to be performed by the general practitioner.
Intervention Type
Behavioral
Intervention Name(s)
Screening HCV. HR-HOSPITAL
Intervention Description
Screening HCV in high risk population by themselves or at referral hospital.
Intervention Type
Behavioral
Intervention Name(s)
Screening HCV. HR-DDP
Intervention Description
Screening HCV in high risk population by themselves or at drug dependence center.
Intervention Type
Behavioral
Intervention Name(s)
Screening HCV. GP-HOSPITAL
Intervention Description
Screening HCV in general population by themselves or at referral hospital.
Intervention Type
Behavioral
Intervention Name(s)
Screening HCV. GP-PCC
Intervention Description
Screening HCV in general population by themselves or at primary care center.
Primary Outcome Measure Information:
Title
Acceptance of the intervention
Description
Overall screening rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Viability
Description
The investigators will measure and report the amount of DBS received from the participants, taking into account the group to which the participants belong.
Time Frame
12 months
Title
Participation
Description
Number of participants by sending their DBS and different possible factors associated to a higher rate of participation.
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: All subjects who have contacted a drug dependence center between 2013 and 2017, as well as patients from a group of a primary care center. Signed informed consent. Exclusion criteria: Patient's refusal to participate in the study. Negative HCV serology or viral load in the last year. Death. Belonging to another health area Not having the patient's address in the hospital's computer system.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Hernandez-Guerra, MD
Phone
+34922678559
Email
mhernand@ull.edu.es
Facility Information:
Facility Name
Complejo Hospitalario Universitario de Canarias
City
La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Hernandez-Guerra, MD
Phone
+34922678559
Email
mhernand@ull.edu.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24331294
Citation
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Citation
Westbrook RH, Dusheiko G. Natural history of hepatitis C. J Hepatol. 2014 Nov;61(1 Suppl):S58-68. doi: 10.1016/j.jhep.2014.07.012. Epub 2014 Nov 3.
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
30513107
Citation
Juanbeltz R, Perez-Garcia A, Aguinaga A, Martinez-Baz I, Casado I, Burgui C, Goni-Esarte S, Reparaz J, Zozaya JM, San Miguel R, Ezpeleta C, Castilla J; EIPT-VHC Study Group. Progress in the elimination of hepatitis C virus infection: A population-based cohort study in Spain. PLoS One. 2018 Dec 4;13(12):e0208554. doi: 10.1371/journal.pone.0208554. eCollection 2018.
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PubMed Identifier
31833860
Citation
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PubMed Identifier
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Citation
Fitz JG. Hepatology after Hepatitis C. Dig Dis. 2016;34(5):603-6. doi: 10.1159/000445276. Epub 2016 Jun 22.
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Acceptance of Hepatitis C Screening by Self-testing in High Risk and General Population

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