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

December 2, 2023 updated by: Manuel Hernandez-Guerra, MD, University of La Laguna

Acceptance and Feasibility of Hepatitis c Screening Strategies in Social Insertion Centers With Alternative Sentences to Prison and Open System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

854

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Santa Cruz De Tenerife
      • San Cristobal de La laguna, Santa Cruz De Tenerife, Spain
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alternative sentences to prison
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.
Diagnostic test: Dried blood spot testing
To evaluate the efficacy defined as the rate of diagnostic tests against hepatitis C virus (HCV) performed with a dried blood spot test
Experimental: Open system
They will be offered to take the diagnostic test in situ at the the Social Insertion Center premises.
Diagnostic test: Dried blood spot testing
To evaluate the efficacy defined as the rate of diagnostic tests against hepatitis C virus (HCV) performed with a dried blood spot test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants in a HCV screening strategy
Time Frame: 1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of HCV
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of La Laguna

Investigators

  • Principal Investigator: Hernández Guerra, University of La Laguna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2023

Primary Completion (Estimated)

January 10, 2024

Study Completion (Estimated)

January 10, 2024

Study Registration Dates

First Submitted

November 20, 2022

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 2, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGSS_CIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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