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