Acceptance and Feasibility of Hepatitis c Screening Strategies in Social Insertion Centers
NCT ID: NCT05756738
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
854 participants
INTERVENTIONAL
2023-03-10
2024-01-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
SCREENING
NONE
Study Groups
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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.
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
Open system
They will be offered to take the diagnostic test in situ at the the Social Insertion Center premises.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent.
Exclusion Criteria
* Minors under 18 years of age and over 79 years of age.
18 Years
79 Years
ALL
Yes
Sponsors
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University of La Laguna
OTHER
Responsible Party
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Manuel Hernandez-Guerra, MD
Principal Investigator
Principal Investigators
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Hernández Guerra
Role: PRINCIPAL_INVESTIGATOR
University of La Laguna
Locations
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Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Countries
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Central Contacts
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Facility Contacts
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Manuel Hernández-Guerra
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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TGSS_CIS
Identifier Type: -
Identifier Source: org_study_id