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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatitis C
- Sponsor
- Andrew Talal
- Enrollment
- 602
- Locations
- 1
- Primary Endpoint
- Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Andrew Talal
Professor
State University of New York at Buffalo
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
Outcomes
Primary Outcomes
Observed 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 Outcomes
- Comparison of Treatment Initiation Percentages(Up to 160 weeks)
- Comparison of Treatment Completion Rates(Up to 210 weeks)
- Comparison of Patient Satisfaction(Baseline (initial time point) and at time HCV is cured, i.e., sustained virological response (up to 210 weeks).)