This study is being done to compare two strategies to deliver HCV treatment to persons with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient opioid treatment program (OTP). Participants will be randomized into one of two treatment groups: 1. Test and treat plus peer-mentors: This treatment group will be offered 8 weeks of glecaprevir/pibrentasvir (an FDA approved HCV treatment) within days of HCV diagnosis at the OTP. Participants in this group will receive treatment adherence support from a peer-mentor who is someone who has been cured of HCV infection. 2. Standard of care HCV treatment referral: This treatment group will be referred to an offsite HCV treatment location. This is the usual care for anyone who tests positive for HCV at the OTP who is not participating in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
198
Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.
Participants are referred to another location for HCV treatment.
University of Alabama
Birmingham, Alabama, United States
University of California, San Francisco
San Francisco, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
University Health Network Toronto
Toronto, Ontario, Canada
Participants Who Initiate HCV Therapy
Participants who start HCV treatment in each arm.
Time frame: Within 12 weeks of randomization
HCV Treatment Completion
Participants who start HCV treatment and subsequently complete treatment (take more than 90% of prescribed treatment course).
Time frame: At expected end of treatment date, up to 20 weeks
Sustained Virologic Response (SVR) Following Treatment by Intervention Group
Participants in each arm who achieved SVR, defined as HCV RNA \<15 IU/mL between 10 and 36 weeks after completion of the HCV treatment regimen.
Time frame: Post-treatment week 12
Time to HCV Treatment Initiation
Time to HCV Treatment Initiation in weeks.
Time frame: From randomization to initiation of treatment, up to 24 weeks
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