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

NCT05756738 | Unknown

• 1 other identifier: TGSS_CIS
• Study Type: interventional
• Target: 854
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Prevalence of HCV

  1 year

Study Arms (2)

Alternative sentences to prison

EXPERIMENTAL

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

Open system

EXPERIMENTAL

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

Diagnostic Test: Dried blood spot testing

Interventions

Dried blood spot testing DIAGNOSTIC_TEST

To evaluate the efficacy defined as the rate of diagnostic tests against hepatitis C virus (HCV) performed with a dried blood spot test

Alternative sentences to prison; Open system

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All persons attending the Social Insertion Center for the first time with alternative sentences to prison and in open system.
• Signed informed consent.

You may not qualify if:

• Refusal of the patient to participate in the study.
• Minors under 18 years of age and over 79 years of age.

Sponsors & Collaborators

• University of La Laguna: lead

Study Sites (1)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

RECRUITING

Related Publications (14)

• European Association for Study of Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2014 Feb;60(2):392-420. doi: 10.1016/j.jhep.2013.11.003. Epub 2013 Dec 9. No abstract available.

  PMID: 24331294 BACKGROUND

• Baumert TF, Juhling F, Ono A, Hoshida Y. Hepatitis C-related hepatocellular carcinoma in the era of new generation antivirals. BMC Med. 2017 Mar 14;15(1):52. doi: 10.1186/s12916-017-0815-7.

  PMID: 28288626 BACKGROUND

• Westbrook RH, Dusheiko G. Natural history of hepatitis C. J Hepatol. 2014 Nov;61(1 Suppl):S58-68. doi: 10.1016/j.jhep.2014.07.012. Epub 2014 Nov 3.

  PMID: 25443346 BACKGROUND

• Buti M, Dominguez-Hernandez R, Casado MA, Sabater E, Esteban R. Healthcare value of implementing hepatitis C screening in the adult general population in Spain. PLoS One. 2018 Nov 28;13(11):e0208036. doi: 10.1371/journal.pone.0208036. eCollection 2018.

  PMID: 30485377 BACKGROUND

• Juanbeltz R, Perez-Garcia A, Aguinaga A, Martinez-Baz I, Casado I, Burgui C, Goni-Esarte S, Reparaz J, Zozaya JM, San Miguel R, Ezpeleta C, Castilla J; EIPT-VHC Study Group. Progress in the elimination of hepatitis C virus infection: A population-based cohort study in Spain. PLoS One. 2018 Dec 4;13(12):e0208554. doi: 10.1371/journal.pone.0208554. eCollection 2018.

  PMID: 30513107 BACKGROUND

• Morales-Arraez D, Hernandez-Guerra M. Electronic Alerts as a Simple Method for Amplifying the Yield of Hepatitis C Virus Infection Screening and Diagnosis. Am J Gastroenterol. 2020 Jan;115(1):9-12. doi: 10.14309/ajg.0000000000000487. No abstract available.

  PMID: 31833860 BACKGROUND

• Crespo J, Albillos A, Buti M, Calleja JL, Garcia-Samaniego J, Hernandez-Guerra M, Serrano T, Turnes J, Acin E, Berenguer J, Berenguer M, Colom J, Fernandez I, Fernandez Rodriguez C, Forns X, Garcia F, Rafael Granados, Lazarus JV, Molero JM, Molina E, Perez Escanilla F, Pineda JA, Rodriguez M, Romero M, Roncero C, Saiz de la Hoya P, Sanchez Antolin G. Elimination of hepatitis C. Positioning document of the Spanish Association for the Study of the Liver (AEEH). Gastroenterol Hepatol. 2019 Nov;42(9):579-592. doi: 10.1016/j.gastrohep.2019.09.002. Epub 2019 Oct 5. English, Spanish.

  PMID: 31594683 BACKGROUND

• Bedford J, Enria D, Giesecke J, Heymann DL, Ihekweazu C, Kobinger G, Lane HC, Memish Z, Oh MD, Sall AA, Schuchat A, Ungchusak K, Wieler LH; WHO Strategic and Technical Advisory Group for Infectious Hazards. COVID-19: towards controlling of a pandemic. Lancet. 2020 Mar 28;395(10229):1015-1018. doi: 10.1016/S0140-6736(20)30673-5. Epub 2020 Mar 17. No abstract available.

  PMID: 32197103 BACKGROUND

• Morales-Arraez D, Hernandez-Bustabad A, Medina-Alonso MJ, Santiago-Gutierrez LG, Garcia-Gil S, Diaz-Flores F, Perez-Perez V, Nazco J, Fernandez de Rota Martin P, Gutierrez F, Hernandez-Guerra M. Telemedicine and decentralized hepatitis C treatment as a strategy to enhance retention in care among people attending drug treatment centres. Int J Drug Policy. 2021 Aug;94:103235. doi: 10.1016/j.drugpo.2021.103235. Epub 2021 Apr 7.

  PMID: 33838399 BACKGROUND

• Saiz de la Hoya P, Marco A, Garcia-Guerrero J, Rivera A; Prevalhep study group. Hepatitis C and B prevalence in Spanish prisons. Eur J Clin Microbiol Infect Dis. 2011 Jul;30(7):857-62. doi: 10.1007/s10096-011-1166-5. Epub 2011 Jan 28.

  PMID: 21274586 BACKGROUND

• Sterling RK, Cherian R, Lewis S, Genther K, Driscoll C, Martin K, Goode MB, Matherly S, Siddiqui MS, Luketic VA, Stravitz RT, Puri P, Lee H, Smith P, Patel V, Sanyal AJ. Treatment of HCV in the Department of Corrections in the Era of Oral Medications. J Correct Health Care. 2018 Apr;24(2):127-136. doi: 10.1177/1078345818762591. Epub 2018 Mar 22.

  PMID: 29566611 BACKGROUND

• Foschi A, Casana M, Radice A, Ranieri R, d'Arminio Monforte A. Hepatitis C management in prisons: An insight into daily clinical practice in three major Italian correctional houses. Hepatology. 2016 Nov;64(5):1821-1822. doi: 10.1002/hep.28609. Epub 2016 May 31. No abstract available.

  PMID: 27118063 BACKGROUND

• Cuadrado A, Cobo C, Mateo M, Blasco AJ, Cabezas J, Llerena S, Fortea JI, Lazaro P, Crespo J. Telemedicine efficiently improves access to hepatitis C management to achieve HCV elimination in the penitentiary setting. Int J Drug Policy. 2021 Feb;88:103031. doi: 10.1016/j.drugpo.2020.103031. Epub 2020 Nov 19.

  PMID: 33221615 BACKGROUND

• Crespo J, Llerena S, Cobo C, Cabezas J. Is HCV elimination possible in prison? Rev Esp Sanid Penit. 2017 Dec;19(3):70-73. doi: 10.4321/S1575-06202017000300001. No abstract available.

  PMID: 29364331 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

Dried Blood Spot Testing

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Hernández Guerra

  University of La Laguna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hernández Guerra

CONTACT

+34922678559; mhernand@ull.edu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: March 6, 2023
• Study Start: March 10, 2023
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)