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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146609
• Other study ID #: TGSS_EXCAD_AP
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: University of La Laguna
• Contact: Manuel Hernandez-Guerra, MD
• Phone: +34922678559
• Email: mhernand[@]ull.edu.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized clinical trial involving patients who between 2013 and 2017 have contacted the drug dependence center and patients from general population.

After selecting those who do not meet any exclusion criteria, a letter will be sent to them inviting them to participate in this study. This letter will contain the study information sheet and informed consent, and a self-testing kit with an explanatory leaflet so that each person can carry out the test in a simple and easy way.

The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing, to study whether support improves participation and to identify predictors of participation.

For the present study, assuming an increase of 18% participation (from 18% to 28% offering support by the patient's referral center, and based on a previous study in our environment of self-testing in the general population), taking into account a power of 80%, alpha error of 5%, and losses of 20%, will require 346 patients per group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1384
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Behavioral:
• Screening HCV. HR-HOSPITAL
Screening HCV in high risk population by themselves or at referral hospital.
• Screening HCV. HR-DDP
Screening HCV in high risk population by themselves or at drug dependence center.
• Screening HCV. GP-HOSPITAL
Screening HCV in general population by themselves or at referral hospital.
• Screening HCV. GP-PCC
Screening HCV in general population by themselves or at primary care center.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Canarias	La Laguna	Santa Cruz De Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
University of La Laguna

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Hepatol. 2014 Jul;61(1):183-4. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance of the intervention	Overall screening rate	12 months
Secondary	Viability	The investigators will measure and report the amount of DBS received from the participants, taking into account the group to which the participants belong.	12 months
Secondary	Participation	Number of participants by sending their DBS and different possible factors associated to a higher rate of participation.	12 months