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

Not Applicable

Completed

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 is a non-blinded stepped wedge cluster randomized controlled trial with two arms: onsite HCV management through telemedicine versus HCV management through usual care, referral to an offsite hepatitis specialist (Referral). The arm assignment is at the cluster (clinic) level. After an initial period (9 months) in which all clinics implement the control intervention (usual care), at regular intervals (i.e., the "steps") of 9 months duration each, one group of clinics is randomized to cross over from the Usual Care arm to the Telemedicine arm. The process continues until all clinics have crossed over to implement telemedicine, and thus all clinics contribute data to both interventions. In addition, patients cured of HCV are followed for two years post-treatment cessation to assess for reinfection or relapse of HCV RNA.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Intervention	Telemedicine	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)

Primary Outcome Measures

Name	Time	Method
Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication	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

Name	Time	Method
Comparison of Treatment Initiation Percentages	Up to 160 weeks	Comparison of treatment initiation percentages between the two arms, as measured by the percentage of patients that take an initial medication dose.
Comparison of Treatment Completion Rates	Up to 210 weeks	Comparison of treatment completion percentages between the two arms.
Comparison of Patient Satisfaction	Baseline (initial time point) and at time HCV is cured, i.e., sustained virological response (up to 210 weeks).	We assessed patient satisfaction with healthcare delivery between the two arms through the Patient Satisfaction Questionnaire (PSQ) (1). The instrument is comprised of 18 questions from 7 subscales with responses on a 5-point Likert scale ranging from "1=Strongly Agree" to "5=Strongly Disagree". We administered the PSQ-18 at baseline and at the SVR time point. The higher the scored value, the higher the satisfaction. We calculated the score per participant, per time point, as the average of the scored values of all questions answered out of 18, and subsequently rounded the average score to the nearest integer (2). 1. Marshall GN, Hays RD. The patient satisfaction questionnaire short-form (PSQ-18). Santa Monica, CA: RAND, 1994. 2. Talal AH, Sofikitou EM, Wang K, Dickerson SS, 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; 29: 395-407.