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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Behavioral: Telemedicine based healthcare programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate Efficacy and Acceptance of a Telemedicine Based Programme to Treat Hepatitis C Among Patients at Drug Addiction Centers
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Acceptance of the intervention with validated satisfaction questionnaire [ Time Frame: 12 months ]
    Grade of patient satisfaction of the telemedicine programme by a validated questionnaire

  2. 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)

  3. Time to sustained virological response rate [ Time Frame: 12 months ]
    Time (months) from DBS testing to achievement of viral eradication

  4. Adherence rate to follow-up [ Time Frame: 12 months ]
    Adherence rate (confirmed assistance) to follow-up appointments in patients with advance fibrosis and cirrhosis

  5. Demographic factors associated with drop-outs [ Time Frame: 12 months ]
    Evaluation of demographic characteristics associated with drop-outs in the cascade of care

  6. Cost-effectiveness of telemedicine strategy [ Time Frame: 12 months ]
    Cost-effectiveness analysis taking in consideration utilities and disease management annual costs of the intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035980


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

Locations
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Spain
Hospital Universitario de Canarias Recruiting
La Laguna, Santa Cruz De Tenerife, Spain, 38320
Contact: Manuel Hernandez-Guerra, MD    34922678559    mhernand@ull.edu.es   
Sponsors and Collaborators
University of La Laguna
Investigators
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Principal Investigator: Manuel Hernandez-Guerra, MD MD
Publications:
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Responsible Party: Manuel Hernandez-Guerra, MD, Principal Investigator, University of La Laguna
ClinicalTrials.gov Identifier: NCT04035980    
Other Study ID Numbers: Telemedicine_HCV
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manuel Hernandez-Guerra, MD, University of La Laguna:
Screening
Telemedicine
Diagnosis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections