Telemedicine for Linkage to Care People Who Injected Drugs With Hepatitis C

• ClinicalTrials.gov Identifier: NCT04035980
• Recruitment Status: Recruiting
• First Posted: July 29, 2019
• Last Update Posted: July 29, 2019
• Sponsor: University of La Laguna
• Information provided by (Responsible Party): Manuel Hernandez-Guerra, MD, University of La Laguna

Tracking Information

• First Submitted Date: July 23, 2019
• First Posted Date: July 29, 2019
• Last Update Posted Date: July 29, 2019
• Actual Study Start Date: July 5, 2019
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 24, 2019)

Efficacy of the intervention [ Time Frame: 12 months ]

Compliance rate (number of patients of the overall participants) with the programme which includes completing screening, liver disease evaluation, treatment and follow-up visit at 12 week

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 24, 2019)

• Acceptance of the intervention with validated satisfaction questionnaire [ Time Frame: 12 months ]
  Grade of patient satisfaction of the telemedicine programme by a validated questionnaire
• Sustained virological response rate [ Time Frame: 12 months ]
  Achievement of viral eradication rate (number of patients from the total with active infection that received treatment and achieved eradication)
• Time to sustained virological response rate [ Time Frame: 12 months ]
  Time (months) from DBS testing to achievement of viral eradication
• Adherence rate to follow-up [ Time Frame: 12 months ]
  Adherence rate (confirmed assistance) to follow-up appointments in patients with advance fibrosis and cirrhosis
• Demographic factors associated with drop-outs [ Time Frame: 12 months ]
  Evaluation of demographic characteristics associated with drop-outs in the cascade of care
• Cost-effectiveness of telemedicine strategy [ Time Frame: 12 months ]
  Cost-effectiveness analysis taking in consideration utilities and disease management annual costs of the intervention

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Telemedicine for Linkage to Care People Who Injected Drugs With Hepatitis C
• Official Title: Clinical Trial to Evaluate Efficacy and Acceptance of a Telemedicine Based Programme to Treat Hepatitis C Among Patients at Drug Addiction Centers
• Brief Summary: The investigators have designed a community-based intervention study to all subjects attended in drug addiction centers screened for hepatitis C virus (HCV) to evaluate the efficacy and acceptance of a telemedicine based programme versus conventional healthcare assistance

Detailed Description

Our current programme of engagement to healthcare and HCV screening based on on-site dried blood spot (DBS) testing has shown to be successful, but with drop-outs in the HCV cascade of care due to economic reasons that difficulties travel costs to appointments, unconsciousness of disease and low awareness of new direct acting antiviral benefits. In this setting, videoconference as a complement to use of serologic scores and dispensing medication outside the hospital could be useful to improve adherence and reduce drop-outs by reducing the visits to hospital from drug addiction centers (DAC), and promoting direct information regarding benefits of been treated with new antivirals free of interferon directly from specialists.

The hypothesis of the study is that the rate of those diagnosed, fully evaluated of liver disease stage, treated and cured will be improved with a lower rate of drop-outs in the cascade of care in the telemedicine arm compared with the conventional arm without affecting satisfaction in the healthcare assistance process.

This is a prospective, randomized, study in which subjects attending DAC will be invited to participate and sign a consent form.

Aims:

• Evaluation of efficacy (compliance rate with the programme which includes completing screening, liver disease evaluation, and treatment)
• Evaluation of acceptance (grade of patient satisfaction of the programme)
• Evaluation of sustained virological response rate and time to achieve eradication
• The adherence rate to follow-up in participants with advanced fibrosis and cirrhosis
• To assess factors associated with drop-outs
• Cost-effectiveness analysis of the telemedicine programme

Methodology:

The investigators have designed a community-based intervention study to evaluate a telemedicine based programme versus conventional healthcare to all subjects attending DAC and screened for HCV if : a) there is no previous documented HCV antibody request or b) with a previous positive HCV antibody test without viral load (RNA) result or positive result without treatment or confirmed sustained virological response or c) with a negative HCV antibody result tested more than one year ago.

In the conventional arm participants after the dried blood spot (DBS) testing for viral load (RNA) and genotype will be referred to the tertiary care hospital in case of a RNA positive result for a one-day appointment for disease stage evaluation with elastography and prescription of treatment with DBS after12 weeks of finishing treatment for assessing sustained virological response.

In the interventional arm the hepatologist will real-time videoconference with the patient-staff at DAC to discuss the need of DBS for viral load and genotype, evaluation of fibrotic stage by serologic scores and if it is the case in known RNA positive cases prescription of treatment. If DBS is mandatory the patient will be scheduled for a second videoconference to start treatment according to results. Dispensing and custody of treatment will be performed at DAC. Follow-up to assess side effects and sustained virological response will be also scheduled by videoconference.

In both arms when advanced fibrosis or cirrhosis has been detected an appointment at the tertiary care hospital for hepatocellular carcinoma screening will be scheduled every 6 months.

Cost analysis will be performed by investigators to assess medical and non-medical costs and satisfaction of the healthcare model by a validated questionnaire. In all the planned strategies subjects will be asked to complete a questionnaire that includes demographic variables.

For the present study, a 15% improvement in the efficacy (compliance with the programme) was hypothesized in the group of participants receiving the interventional strategy compared to the conventional strategy. Taking into account a power of 80%, alpha error of 5% and losses of 10% will require 83 participants per group.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Parallel Assignment

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Hepatitis C Virus Infection

Intervention

Behavioral: Telemedicine based healthcare programme

Two-way videoconference to evaluate the need of screening with DBS, disease stage evaluation and treatment of HCV RNA positive patients at drug addiction centers

Study Arms

• No Intervention: Conventional care
  Screening HCV with dried blod spot (DBS) testing and referral to tertiary care hospital to evaluate disease stage and treatment of HCV RNA positive patients
• Active Comparator: Telemedicine care
  Two-way videoconference to evaluate the need of screening with DBS, disease stage evaluation and treatment of HCV RNA positive patients at drug addiction centers
  Intervention: Behavioral: Telemedicine based healthcare programme

Publications *

• García-Fulgueiras A, García-Pina R, Morant C, de Larrea-Baz NF, Alvarez E. Burden of disease related to hepatitis C and hepatitis B in Spain: a methodological challenge of an unfolding health problem. J Viral Hepat. 2011 Oct;18(10):e453-60. doi: 10.1111/j.1365-2893.2011.01467.x. Epub 2011 Jun 1.
• Vallejo F, Barrio G, Brugal MT, Pulido J, Toro C, Sordo L, Espelt A, Bravo MJ; Itinere Project Group. High hepatitis C virus prevalence and incidence in a community cohort of young heroin injectors in a context of extensive harm reduction programmes. J Epidemiol Community Health. 2015 Jun;69(6):599-603. doi: 10.1136/jech-2014-205070. Epub 2015 Apr 13.
• Coats JT, Dillon JF. The effect of introducing point-of-care or dried blood spot analysis on the uptake of hepatitis C virus testing in high-risk populations: A systematic review of the literature. Int J Drug Policy. 2015 Nov;26(11):1050-5. doi: 10.1016/j.drugpo.2015.05.001. Epub 2015 Jun 4. Review.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 24, 2019): 166
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2020
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subjects 18 years old or older with a valid sanitary card in our public health system
• Signed Informed consent
• Tested for HCV: a) no previous documented HCV antibody request or b) with a previous positive HCV antibody test without RNA result or positive result without treatment or confirmed sustained virological response or c) with a negative HCV antibody result tested more than one year ago
• No current surveillance by any hepatitis specialized care (hepatology or internal medicine)

Exclusion Criteria:

• Previous DBS testing at DAC lost to follow-up

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Manuel N Hernandez-Guerra, MD; 34922678559; mhernand@ull.edu.es

• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04035980
• Other Study ID Numbers: Telemedicine_HCV
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Manuel Hernandez-Guerra, MD, University of La Laguna
• Study Sponsor: University of La Laguna
• Collaborators: Not Provided

Investigators

• Principal Investigator: Manuel Hernandez-Guerra, MD; MD

• PRS Account: University of La Laguna
• Verification Date: July 2019