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

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

Tracking Information
First Submitted Date  ICMJE July 23, 2019
First Posted Date  ICMJE July 29, 2019
Last Update Posted Date July 29, 2019
Actual Study Start Date  ICMJE July 5, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telemedicine for Linkage to Care People Who Injected Drugs With Hepatitis C
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus Infection
Intervention  ICMJE 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2019)
166
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Manuel N Hernandez-Guerra, MD 34922678559 mhernand@ull.edu.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04035980
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Manuel Hernandez-Guerra, MD, University of La Laguna
Study Sponsor  ICMJE University of La Laguna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manuel Hernandez-Guerra, MD MD
PRS Account University of La Laguna
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP