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Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals

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ClinicalTrials.gov Identifier: NCT02933970
Recruitment Status : Recruiting
First Posted : October 14, 2016
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Andrew Talal, State University of New York at Buffalo

Brief Summary:
To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in most cases will be referral to an offsite location for HCV management. The effectiveness will be expressed through the primary patient centered and clinical outcome, achievement of viral eradication, defined as undetectable HCV RNA 12 weeks post-treatment cessation.

Condition or disease Intervention/treatment Phase
Hepatitis C Other: Telemedicine Not Applicable

Detailed Description:
The study will be conducted as a non-blinded stepped wedge cluster randomized controlled trial with two arms: onsite HCV management through telemedicine versus HCV management through usual care, which in most cases will be referral to an offsite liver specialist (Referral). The arm assignment will be at the cluster (clinic) level. After an initial period (6 months) in which all clinics implement the control intervention (usual care), at regular intervals (i.e., the "steps") of 6 months duration each, one group of clinics will be randomized to cross over from the Usual Care arm to the Telemedicine arm. In this way, there will be enough time for implementation and assessment of the intervention within each time period. The process continues until all clinics have crossed over to implement telemedicine, and thus all clinics contribute data to both interventions. In addition, patients will be followed for two years post-treatment cessation to assess for reinfection or relapse of HCV RNA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 624 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Stepped-Wedge Randomized Control Trial to Compare Integrated, Co-located, Telemedicine-based HCV Management for Individuals on Opiate Agonist Treatment Versus Usual Care Treatment of HCV of Individuals on Opiate Agonist Treatment
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Referral-HCV seropositive subjects enrolled for at least 12 months in an opiate agonist treatment (OAT) program will be referred to an off-site liver specialist
Intervention
Telemedicine - HCV seropositive subjects enrolled for at least 12 months in an OAT program will be treated on site by a liver specialist via two-way video conferencing. (telemedicine)
Other: Telemedicine
Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member
Other Name: Two way video conferencing




Primary Outcome Measures :
  1. Percentage of patients in both arms who achieve viral eradication [ Time Frame: 12 weeks post treatment cessation ]
    Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)


Secondary Outcome Measures :
  1. Comparison of treatment initiation rates [ Time Frame: Up to 160 weeks ]
    Comparison of treatment initiation rates between the two arms, as measured by the proportion of patients that take an initial medication dose.

  2. Comparison of treatment completion rates [ Time Frame: Up to 210 weeks ]
    Comparison of treatment completion rates between the two arms.

  3. Comparison of patient satisfaction [ Time Frame: Up to 210 weeks ]
    Comparison of patient satisfaction with healthcare delivery between the two arms as assessed through HCV Patient Satisfaction Questionnaire.

  4. Treatment adherence rates [ Time Frame: Up to 210 weeks ]
    Comparison of treatment adherence rates between the two arms as measured by attendance at scheduled specialist, telemedicine visits and medication adherence.



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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:

  1. HCV antibody detected
  2. Ability and willingness of subject or legal representative to provide written informed consent.
  3. 18 years of age
  4. A minimum of 12-month enrollment in the opiate agonist treatment program
  5. Likely to be adherent to the therapeutic regimen
  6. Covered by medical insurance

Exclusion Criteria:

  1. Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain.
  2. <18 years of age
  3. < 12 months enrolled in an opiate agonist treatment program.
  4. Non-compliance with therapeutic regimen defined as three consecutive missed appointments that will result in a discussion between the principal investigator at the site and the study participant to determine the reason for the missed appointments. Continuation in the study for the participant will be assessed on a case-by-case basis between the study PI and the site PI.
  5. Lack of medical insurance coverage
  6. Ineligibility for HCV treatment
  7. Active treatment for HCV at the time of the study enrollment

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): NCT02933970


Contacts
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Contact: Andrew H Talal, MD 716 829-6208 ahtalal@buffalo.edu
Contact: Heidi Nieves-McGrath, BSN 716 888-4739 hnievesm@buffalo.edu

Locations
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United States, New York
University at Buffalo Recruiting
Buffalo, New York, United States, 14203
Contact: Heidi Nieves-McGrath    716-888-4739    hnievesm@buffalo.edu   
Contact: Andrew Talal    7168884737    ahtalal@buffalo.edu   
Principal Investigator: Andrew H Talal         
Sponsors and Collaborators
Andrew Talal
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Andrew H Talal, MD SUNY Buffalo

Additional Information:
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Responsible Party: Andrew Talal, Professor, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT02933970     History of Changes
Other Study ID Numbers: Telemedicine vs. Usual Care
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At the completion of the study, the data will be filed with the Patient-Centered Outcomes Research Institute and will be publicly availability.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases