Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System in Brazil

August 24, 2021 updated by: Hospital de Clinicas de Porto Alegre

Monitoring of Hepatitis C Therapy Using Telemedicine in a Simplified Protocol With Pangenotypic Regimen in Non-cirrhotic Patients - a Single Group Clinical Trial in the National Public Health System in Brazil

The study is a non-randomized, single group clinical trial on monitoring hepatitis C therapy using telemedicine. Patients with chronic hepatitis C without cirrhosis will be treated with the pangenotypic regimen of direct acting antivirals sofosbuvir and velpatasvir for 12 weeks after a single visit to the clinic, in which treatment will be prescribed. Patients will be then monitored by telemedicine tools, like instant message application, telephone and video calls and by his or her primary physician when needed. Twelve weeks after treatment conclusion, hepatitis C virus RNA levels will be measured on a blood sample, indicating the cure rate and efficacy of this protocol on HCV treatment.

The primary objective of the study is to address the feasibility and applicability of the usage of telemedicine tools to increase access and monitor HCV treatment with direct-acting antivirals in public health in Brazil.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Scientific rationale

It's estimated that 0.7% of the Brazilian population is infected with hepatitis C virus (HCV). In March 2018, the Ministry of Health defined all patients with HCV to be able to receive direct-acting antivirals (DAAs) from the public health system without any charges. Though this "universal-access policy", frequently there are still many obstacles for patients to actually get at the treatment: patients living in cities distant from big centres and underserved by specialized physicians in the country, lack of medical doctors experienced in HCV treatment in the public system, delay between prescription and starting of medications because of administrative issues, and socioeconomic vulnerability among people.

Telemedicine tools are powerful ways of reaching people living distant from big centres, and there are some successful international experiences with hepatitis C treatment in this field, like Project ECHO® (Extension for Community Healthcare Outcomes). In Brazil, there is a national program, geographically located in Porto Alegre, that uses telemedicine to improve healthcare quality in primary care by offering continuous education and teleconsultations (by text or toll-free hotline) to community physicians and other healthcare professionals working in public primary care institutions all over the country.

Primary objective

To address the applicability of telemedicine tools to increase access and monitor HCV treatment with direct-acting antivirals in public health in Brazil.

Research methods

HCV-infected patients in the waiting list for specialized consultation with gastroenterologist or infectious disease physician will be recruited to a meeting that will consist of a HCV lecture followed by individual, focused consultation with medical history, analysis of previous lab results (including fibrosis evaluation by the AST-to-platelets ratio index - APRI) and collection of blood samples. All patients will receive a prescription of pan-genotypic DAA sofosbuvir and velpatasvir regimen for 12 weeks according to the Brazilian Ministry of Health's Treatment Protocol, along with orientations about use and potential side effects and ways to contact the telemedicine centre - mobile phone instant messages and WhatsApp® messages, phone calls and video calls. Issues regarding the administrative process will be held by the study team and medications will be delivered to each patient's city or region at the time they're available.

Before starting treatment, patients will be oriented about treatment administration, its potential side effects and ways of contacting the research team by text messages, phone calls and, when appropriate, teleconsultation by video teleconference with the patient and one of the healthcare professionals of the study. During the treatment course, adverse effects will be monitored and, when present, graded by the Division of AIDS (DAIDS) Table from the National Institutes of Health.

The family physicians working in each patient area will be oriented about this study and HCV treatment. Moreover, they will be invited to join the regular Project ECHO® meetings held by the Brazilian centre located at Porto Alegre. Healthcare professionals also have the toll-free hotline to get in touch with the telemedicine program and investigators. HCV-RNA will be collected 12 weeks after the end of therapy at a local institution next to patient home or city.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-007
        • Hospital De Clinicas De Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have voluntarily signed the informed consent form;
  • Chronic hepatitis C confirmed by positive HCV-RNA;
  • Have been referred to specialized consultation in gastroenterology or infectious disease in the Brazilian Public Health System in Porto Alegre;
  • Have previous fibrosis staging (eg. liver biopsy, Fibroscan®) or laboratory tests for APRI score calculation.

Exclusion Criteria:

  • Suspicion or diagnosis of cirrhosis based on:
  • Hepatic elastography ≥12.5 kPa on Fibroscan®;
  • APRI score ≥2.0;
  • Clinical, ultrasound or endoscopic evidence of cirrhosis or portal hypertension;
  • Previous HCV treatment with direct acting antivirals;
  • HIV coinfection with antiretroviral treatment incompatible with HCV antivirals;
  • Previous solid organ transplant;
  • Significant comorbidity that may interfere with the HCV treatment
  • Creatinine clearance < 30 mL/min;
  • Platelets < 150.000/mL;
  • Pregnant or breastfeeding female;
  • Woman of childbearing age without use or that does not accept to use effective contraception during treatment and during the 30 days after treatment end;
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telemedicine
Sofosbuvir 400mg and velpatasvir 100mg qd for 12 weeks Telemedicine support
Other: Telemedicine
Telemedicine monitoring and teleconsultation by video calls
Drug: Velpatasvir/Sofosbuvir
Velpatasvir 100mg / Sofosbuvir 400mg once a day for twelve weeks
Other Names:
  • Epclusa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sustained virologic response
Time Frame: 12 weeks post end of antiviral therapy (SVR12)
Proportion of treated patients with undetectable hepatitis C virus RNA levels measured by a real time polymerase chain reaction (PCR) with a lower limit of detection ≤ 12 IU/mL
12 weeks post end of antiviral therapy (SVR12)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to antiviral treatment
Time Frame: 12 weeks after antiviral treatment initiation
Proportion of patients with treatment completion
12 weeks after antiviral treatment initiation
Patient satisfaction with the treatment
Time Frame: 12 weeks post end of antiviral therapy (SVR12)
Patient satisfaction with the telemedicine support measured by a a questionnaire applied to all participants
12 weeks post end of antiviral therapy (SVR12)
Adverse effects
Time Frame: 12 weeks post end of antiviral therapy (SVR12)
Incidence of adverse effects related to treatment reported by patients
12 weeks post end of antiviral therapy (SVR12)
Severe adverse effects
Time Frame: 12 weeks post end of antiviral therapy (SVR12)
Incidence of severe or life threatening (grade 3 or 4) adverse effects related to treatment reported by patients
12 weeks post end of antiviral therapy (SVR12)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of primary physicians participation after invitation to project ECHO®
Time Frame: 12 weeks post end of antiviral therapy (SVR12)
To address the participation rate on Project ECHO® meetings of primary care physicians who referred patients enrolled in the study
12 weeks post end of antiviral therapy (SVR12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Brazil
TelessaúdeRS / UFRGS
State Secretary of Health of Rio Grande do Sul

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mario R Alvares-da-Silva, PhD, Hospital De Clinicas De Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-0290
  • Plataforma Brasil (CAAE) (Other Identifier: 91278418200005327)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to open data that might be useful for policy makers, specially in Brazil, and for researchers interested in replicate the study.

IPD Sharing Time Frame

starting after the publication

IPD Sharing Access Criteria

Researchers or public health policy makers interested in perform analyses to replicate the study or protocol of telemonitoring.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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