Acceptance of Hepatitis C Screening by Self-testing in High Risk and General Population

NCT05146609 | Unknown

• 1 other identifier: TGSS_EXCAD_AP
• Study Type: interventional
• Target: 1,384
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing assisted by center of origin or referral hospital, as a strategy for screening for hepatitis C virus (HCV) in high risk population (ex-users of drug dependence centers) compared to the general population assisted by primary care centers.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Acceptance of the intervention

  Overall screening rate

  12 months

Secondary Outcomes (2)

• Viability

  12 months

• Participation

  12 months

Study Arms (4)

HR-HOSPITAL

EXPERIMENTAL

Patients assigned to the strategy HR-HOSPITAL, who are high risk population (HR), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the referral hospital.

Behavioral: Screening HCV. HR-HOSPITAL

HR-DDP

EXPERIMENTAL

Patients assigned to the strategy HR-DDP, who are high risk population, will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the drug dependence center (DDP) the participants used to attend.

Behavioral: Screening HCV. HR-DDP

GP-HOSPITAL

EXPERIMENTAL

Patients assigned to the strategy GP-HOSPITAL, who are general population (GP), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the referral hospital.

Behavioral: Screening HCV. GP-HOSPITAL

GP-PCC

EXPERIMENTAL

Patients assigned to the strategy GP-PCC, who are general population (GP), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the primary care center (PCC) to be performed by the general practitioner.

Behavioral: Screening HCV. GP-PCC

Interventions

Screening HCV. HR-HOSPITAL BEHAVIORAL

Screening HCV in high risk population by themselves or at referral hospital.

HR-HOSPITAL

Screening HCV. HR-DDP BEHAVIORAL

Screening HCV in high risk population by themselves or at drug dependence center.

HR-DDP

Screening HCV. GP-HOSPITAL BEHAVIORAL

Screening HCV in general population by themselves or at referral hospital.

GP-HOSPITAL

Screening HCV. GP-PCC BEHAVIORAL

Screening HCV in general population by themselves or at primary care center.

GP-PCC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects who have contacted a drug dependence center between 2013 and 2017, as well as patients from a group of a primary care center.
• Signed informed consent.

You may not qualify if:

• Patient's refusal to participate in the study.
• Negative HCV serology or viral load in the last year.
• Death.
• Belonging to another health area
• Not having the patient's address in the hospital's computer system.

Sponsors & Collaborators

• University of La Laguna: lead

Study Sites (1)

Complejo Hospitalario Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

RECRUITING

Related Publications (12)

• 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

• Sarin SK, Kumar M. Natural history of HCV infection. Hepatol Int. 2012 Oct;6(4):684-95. doi: 10.1007/s12072-012-9355-6. Epub 2012 Mar 9.

  PMID: 26201520 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

• Fitz JG. Hepatology after Hepatitis C. Dig Dis. 2016;34(5):603-6. doi: 10.1159/000445276. Epub 2016 Jun 22.

  PMID: 27332966 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

• 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

• 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

• Blach S, Kondili LA, Aghemo A, Cai Z, Dugan E, Estes C, Gamkrelidze I, Ma S, Pawlotsky JM, Razavi-Shearer D, Razavi H, Waked I, Zeuzem S, Craxi A. Impact of COVID-19 on global HCV elimination efforts. J Hepatol. 2021 Jan;74(1):31-36. doi: 10.1016/j.jhep.2020.07.042. Epub 2020 Aug 7.

  PMID: 32777322 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

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

Central Study Contacts

Manuel Hernandez-Guerra, MD

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: Medical Doctor

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: December 7, 2021
• Study Start: February 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)