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Acceptance and Feasibility of Hepatitis c Screening Strategies in Social Insertion Centers (TGSS_CIS)

Primary Purpose

Hepatitis C Virus

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dried blood spot testing
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 Virus

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All persons attending the Social Insertion Center for the first time with alternative sentences to prison and in open system. Signed informed consent. Exclusion Criteria: Refusal of the patient to participate in the study. Minors under 18 years of age and over 79 years of age.

Sites / Locations

  • Hospital Universitario de CanariasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Alternative sentences to prison

Open system

Arm Description

Persons with alternative sentences to prison will be informed of the study and, according to the randomization code, will be: a) given an envelope with all the necessary material to carry out the test at home and send it to the hospital for processing or, b) be tested on site at the the Social Insertion Center premises, who will also send it to the hospital for processing by the Central Laboratory of the University Hospital of the Canary Islands.

They will be offered to take the diagnostic test in situ at the the Social Insertion Center premises.

Outcomes

Primary Outcome Measures

Number of participants in a HCV screening strategy
To evaluate the efficacy defined as the rate of diagnostic tests against hepatitis C virus (HCV) performed within a decentralized diagnostic strategy integrated by self-testing at home compared to that performed in situ in the population served in a Social Insertion Center with alternative prison sentences.

Secondary Outcome Measures

Prevalence of HCV
To study the prevalence and characteristics of patients with active HCV infection who are treated in the Social Insertion Center with alternative prison sentences compared to those in open system, so better and more specialized screening strategies are developed.

Full Information

First Posted
November 20, 2022
Last Updated
May 8, 2023
Sponsor
University of La Laguna
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1. Study Identification

Unique Protocol Identification Number
NCT05756738
Brief Title
Acceptance and Feasibility of Hepatitis c Screening Strategies in Social Insertion Centers
Acronym
TGSS_CIS
Official Title
Acceptance and Feasibility of Hepatitis c Screening Strategies in Social Insertion Centers With Alternative Sentences to Prison and Open System
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
June 10, 2023 (Anticipated)
Study Completion Date
January 10, 2024 (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

5. Study Description

Brief Summary
Hepatitis C virus (HCV) infection is one of the leading causes of chronic liver disease worldwide. It is a progressive disease that without treatment leads to the development of cirrhosis in approximately 10-20% of patients. With this study the investigators intend to evaluate the efficacy defined as the rate of HCV diagnostic tests performed within a decentralized diagnostic strategy by means of home self-testing compared to the one performed in situ in the population served in Social Insertion Centers (CIS) with alternative prison sentences, in order to study the prevalence and characteristics associated with HCV infection in this population, which is known to be at risk for this disease, and to offer them treatment and cure.
Detailed Description
A randomized study will be designed in which all persons attending the Social Insertion Center to serve alternative sentences to prison will be invited to participate on a voluntary basis, with prior informed consent. In order to study the prevalence of these persons compared to persons in open system, the latter will be offered, with prior informed consent, to take the diagnostic test in situ at the CIS premises. All persons will be given a survey with sociodemographic and clinical variables to identify predictor factors. People with alternative sentences to prison will be informed of the study and, according to the randomization code, will be: a) given an envelope with all the necessary material to carry out the test at home and send it to the hospital for processing or, b) be tested on site at the CIS premises by the CIS nurse, who will also send it to the hospital for processing within 30 days by the Central Laboratory of the University Hospital of the Canary Islands.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized study will be designed in which all persons attending the Social Insertion Center (CIS) to serve alternative sentences to prison will be invited to participate. In order to study the prevalence of these persons compared to persons in open system, the latter will be offered to take the diagnostic test in situ at the CIS premises. Persons with alternative sentences to prison will be informed of the study and, according to the randomization code, will be: a) given an envelope with all the necessary material to carry out the test at home and send it to the hospital for processing or, b) be tested on site at the CIS premises, who will also send it to the hospital for processing by the Central Laboratory of the University Hospital of the Canary Islands. All patients who have participated will be notified by telephone of the test result, and patients with a diagnosis of active infection will be contacted and given an appointment to be evaluated and treated.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
854 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alternative sentences to prison
Arm Type
Experimental
Arm Description
Persons with alternative sentences to prison will be informed of the study and, according to the randomization code, will be: a) given an envelope with all the necessary material to carry out the test at home and send it to the hospital for processing or, b) be tested on site at the the Social Insertion Center premises, who will also send it to the hospital for processing by the Central Laboratory of the University Hospital of the Canary Islands.
Arm Title
Open system
Arm Type
Experimental
Arm Description
They will be offered to take the diagnostic test in situ at the the Social Insertion Center premises.
Intervention Type
Diagnostic Test
Intervention Name(s)
Dried blood spot testing
Intervention Description
To evaluate the efficacy defined as the rate of diagnostic tests against hepatitis C virus (HCV) performed with a dried blood spot test
Primary Outcome Measure Information:
Title
Number of participants in a HCV screening strategy
Description
To evaluate the efficacy defined as the rate of diagnostic tests against hepatitis C virus (HCV) performed within a decentralized diagnostic strategy integrated by self-testing at home compared to that performed in situ in the population served in a Social Insertion Center with alternative prison sentences.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Prevalence of HCV
Description
To study the prevalence and characteristics of patients with active HCV infection who are treated in the Social Insertion Center with alternative prison sentences compared to those in open system, so better and more specialized screening strategies are developed.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All persons attending the Social Insertion Center for the first time with alternative sentences to prison and in open system. Signed informed consent. Exclusion Criteria: Refusal of the patient to participate in the study. Minors under 18 years of age and over 79 years of age.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hernández Guerra
Phone
+34922678559
Email
mhernand@ull.edu.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hernández Guerra
Organizational Affiliation
University of La Laguna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de Canarias
City
San Cristobal de La laguna
State/Province
Santa Cruz De Tenerife
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Hernández-Guerra
Phone
+34922678559
Email
mhernand@ull.edu.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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24331294
Citation
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Acceptance and Feasibility of Hepatitis c Screening Strategies in Social Insertion Centers

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