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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hepatitis C

Intervention / Treatment
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* Other: Telemedicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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 | |
| Other: Intervention<br>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<br>* Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member<br>* Other names: Two way video conferencing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 weeks post treatment cessation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 160 weeks | 
| Comparison of treatment completion rates | Comparison of treatment completion rates between the two arms. | Up to 210 weeks | 
| Comparison of patient satisfaction | Comparison of patient satisfaction with healthcare delivery between the two arms as assessed through HCV Patient Satisfaction Questionnaire. | Up to 210 weeks | 
| Treatment adherence rates | Comparison of treatment adherence rates between the two arms as measured by attendance at scheduled specialist, telemedicine visits and medication adherence. | Up to 210 weeks |