Clinical trial NCT02933970: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-10-14
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication
timeFrame: 12 weeks post treatment cessation
Secondary outcomes:
measure: Comparison of Treatment Initiation Percentages
timeFrame: Up to 160 weeks
measure: Comparison of Treatment Completion Rates
timeFrame: Up to 210 weeks
measure: Comparison of Patient Satisfaction
timeFrame: Baseline (initial time point) and at time HCV is cured, i.e., sustained virological response (up to 210 weeks).
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Andrew H Talal
state: New York
Study officials:
affiliation: SUNY Buffalo
name: Andrew H Talal, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.