NCT02933970

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: Andrew Talal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
OTHER	Telemedicine	Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member

Timeline

• Start date: 2017-02-28
• Primary completion: 2020-10-01
• Completion: 2022-11-01
• First posted: 2016-10-14
• Last updated: 2024-12-20
• Results posted: 2024-12-02

Locations

1 site across 1 country: United States