Back to resultsComparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals
Primary Purpose
Hepatitis C
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
About this trial
This is an interventional health services research trial for Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- HCV antibody detected
- Ability and willingness of subject or legal representative to provide written informed consent.
- 18 years of age
- A minimum of 12-month enrollment in the opiate agonist treatment program
- Likely to be adherent to the therapeutic regimen
- Covered by medical insurance
Exclusion Criteria:
- Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain.
- <18 years of age
- < 12 months enrolled in an opiate agonist treatment program.
- 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.
- Lack of medical insurance coverage
- Ineligibility for HCV treatment
- Active treatment for HCV at the time of the study enrollment
Sites / Locations
- Andrew H Talal
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Control
Intervention
Arm Description
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
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)
Outcomes
Primary Outcome Measures
Percentage of patients in both arms who achieve viral eradication
Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)
Secondary Outcome Measures
Comparison of treatment initiation rates
Comparison of treatment initiation rates between the two arms, as measured by the proportion of patients that take an initial medication dose.
Comparison of treatment completion rates
Comparison of treatment completion rates between the two arms.
Comparison of patient satisfaction
Comparison of patient satisfaction with healthcare delivery between the two arms as assessed through HCV Patient Satisfaction Questionnaire.
Treatment adherence rates
Comparison of treatment adherence rates between the two arms as measured by attendance at scheduled specialist, telemedicine visits and medication adherence.
Full Information
NCT ID
NCT02933970
First Posted
September 24, 2016
Last Updated
November 1, 2022
Sponsor
Andrew Talal
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02933970
Brief Title
Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrew Talal
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
602 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Arm Title
Intervention
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Telemedicine
Other Intervention Name(s)
Two way video conferencing
Intervention Description
Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member
Primary Outcome Measure Information:
Title
Percentage of patients in both arms who achieve viral eradication
Description
Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)
Time Frame
12 weeks post treatment cessation
Secondary Outcome Measure Information:
Title
Comparison of treatment initiation rates
Description
Comparison of treatment initiation rates between the two arms, as measured by the proportion of patients that take an initial medication dose.
Time Frame
Up to 160 weeks
Title
Comparison of treatment completion rates
Description
Comparison of treatment completion rates between the two arms.
Time Frame
Up to 210 weeks
Title
Comparison of patient satisfaction
Description
Comparison of patient satisfaction with healthcare delivery between the two arms as assessed through HCV Patient Satisfaction Questionnaire.
Time Frame
Up to 210 weeks
Title
Treatment adherence rates
Description
Comparison of treatment adherence rates between the two arms as measured by attendance at scheduled specialist, telemedicine visits and medication adherence.
Time Frame
Up to 210 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HCV antibody detected
Ability and willingness of subject or legal representative to provide written informed consent.
18 years of age
A minimum of 12-month enrollment in the opiate agonist treatment program
Likely to be adherent to the therapeutic regimen
Covered by medical insurance
Exclusion Criteria:
Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain.
<18 years of age
< 12 months enrolled in an opiate agonist treatment program.
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.
Lack of medical insurance coverage
Ineligibility for HCV treatment
Active treatment for HCV at the time of the study enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew H Talal, MD
Organizational Affiliation
SUNY Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andrew H Talal
City
Buffalo
State/Province
New York
ZIP/Postal Code
14216
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35925809
Citation
Talal AH, Sofikitou EM, Wang K, Dickerson S, Jaanimagi U, Markatou M. High Satisfaction with Patient-Centered Telemedicine for Hepatitis C Virus Delivered to Substance Users: A Mixed-Methods Study. Telemed J E Health. 2023 Mar;29(3):395-407. doi: 10.1089/tmj.2022.0189. Epub 2022 Aug 4.
Results Reference
derived
Links:
URL
http://www.who.int/mediacentre/factsheets/fs164/en/.
Description
Related Info
URL
http://www.cdnetwork.org/teamc
Description
Related Info
Learn more about this trial
Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals
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