Clinical trial NCT05756738: Acceptance and Feasibility of Hepatitis c Screening Strategies in Social Insertion Centers
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
Overall status: RECRUITING
Phase: NA
Conditions: Hepatitis C Virus
Lead sponsor: University of La Laguna
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 854
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Number of participants in a HCV screening strategy
timeFrame: 1 year
Secondary outcomes:
measure: Prevalence of HCV
timeFrame: 1 year
Other outcomes:
Locations:
city: San Cristobal de La laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
Study officials:
affiliation: University of La Laguna
name: Hernández Guerra
role: PRINCIPAL_INVESTIGATOR
References:
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