The proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C care. Accessible Care for PWID is low-threshold care provided in programs designed specifically for PWID where they can comfortably access care without fear of shame or stigma. Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator (HCCC), on-site at a collaborating needle exchange program. The proposed study will compare the effectiveness of Accessible Care with Usual Care (referrals to existing services) in facilitating linkage, engagement, and retention of PWID in care for hepatitis C, addiction, and HIV prevention. The primary outcome is sustained virologic response, which constitutes virologic cure. Substance use and HIV and HCV risk behaviors are secondary outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
167
Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator, on-site at our collaborating needle exchange program.
Usual care entails referral to an on site HCV care coordinator (not provided by study)
Lower East Side Harm Reduction Center
New York, New York, United States
Proportion of Patients to Achieve SVR12 at 1 Year
SVR12 is a sustained virologic response to HCV treatment defined as HCV RNA below the limit of quantification 12 weeks post completion of HCV treatment
Time frame: each participant will be assessed at 1 year post entry
Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider
Proportion of patients in each arm referred to hepatitis C treatment provider by 12 months
Time frame: each participant will be assessed at 1 year post entry
The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit
The proportion of participants in each arm who attend an initial visit with a hepatitis treatment provider post randomization.
Time frame: end of study (12 months)
Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment
Proportion of patients in each arm who complete a medical evaluation for antiviral treatment, including a history, physical examination and laboratory evaluation
Time frame: each participant will be assessed at 1 year post entry
Proportion of Participants in Each Arm Who Initiated Treatment
Proportion of participants in each arm physically receiving the first dose of antiviral medication (without necessarily having confirmed ingestion)
Time frame: Each participant will be assessed 1 year post entry
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