Clinical trial NCT04035980: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C Virus Infection
Keywords: Screening
Telemedicine
Diagnosis
Lead sponsor: University of La Laguna
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy of the intervention
timeFrame: 12 months
Secondary outcomes:
measure: Acceptance of the intervention with validated satisfaction questionnaire
timeFrame: 12 months
measure: Sustained virological response rate
timeFrame: 12 months
measure: Time to sustained virological response rate
timeFrame: 12 months
measure: Adherence rate to follow-up
timeFrame: 12 months
measure: Demographic factors associated with drop-outs
timeFrame: 12 months
measure: Cost-effectiveness of telemedicine strategy
timeFrame: 12 months
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
Study officials:
affiliation: MD
name: Manuel Hernandez-Guerra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Fulgueiras A, Garcia-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.
citation: 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.
citation: 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.