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

University of La Laguna

Status: Enrolling

Conditions: Hepatitis C Virus

Treatments: Diagnostic Test: Dried blood spot testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05756738

TGSS_CIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 854 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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854 participants in 2 patient groups

Alternative sentences to prison

Experimental group

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.

Treatment:

Diagnostic Test: Dried blood spot testing

Open system

Experimental group

Description:

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

Treatment:

Diagnostic Test: Dried blood spot testing