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

Sponsor
University of La Laguna (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05756738
Collaborator
(none)
854
Enrollment
2
Arms
10.1
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Dried blood spot testing
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
854 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Screening
Official Title:
Acceptance and Feasibility of Hepatitis c Screening Strategies in Social Insertion Centers With Alternative Sentences to Prison and Open System
Anticipated Study Start Date :
Mar 10, 2023
Anticipated Primary Completion Date :
Jun 10, 2023
Anticipated Study Completion Date :
Jan 10, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants in a HCV screening strategy [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.

Secondary Outcome Measures

  1. Prevalence of HCV [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of La Laguna

Investigators

  • Principal Investigator: Hernández Guerra, University of La Laguna

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Manuel Hernandez-Guerra, MD, Principal Investigator, University of La Laguna
ClinicalTrials.gov Identifier:
NCT05756738
Other Study ID Numbers:
  • TGSS_CIS
First Posted:
Mar 6, 2023
Last Update Posted:
Mar 7, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis

Study Results

No Results Posted as of Mar 7, 2023