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N/A N=755 Randomized Treatment

Patient-Centered Models of HCV Care for People Who Inject Drugs

Hepatitis C · Medication Adherence

Enrolled (actual)
755
Serious AEs
2.3%
Results posted
Sep 2024
Primary outcome: Primary: Sustained Viral Response (SVR) — 226; 236 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Patient Navigation (Behavioral); modified Directly Observed Therapy (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Prisma Health-Upstate
Primary completion
Mar 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Sustained Viral Response (SVR)
226; 236
SECONDARY
HCV DAA Treatment Initiation
306; 317
SECONDARY
Adherence (by Electronic Monitors)
78; 73.4
SECONDARY
HCV DAA Treatment Completion
251; 264
SECONDARY
Resistance (to NS5A)
SECONDARY
Resistance (to NS5B)

Summary

People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than do other groups. Effective, safe new treatments called direct-acting antiviral agents (DAAs) have been developed recently. Unfortunately, PWID rarely get these treatments. The drugs are expensive, so insurers often do not cover the cost of DAAs. Sometimes providers hesitate to prescribe DAAs because they are concerned that PWID won't take their medication or that these patients might become reinfected. Several good models for treating PWID exist. One of them is to provide directly observed treatment (DOT). Another model provides treatment to PWID with the support of patient navigators (PN), public health workers who offer support and education to patients. Though both the DOT and PN models have been successful, we still don't know which model works best. In this study, the investigators will study both DOT and PN models for treating HCV in PWID. The investigators' goal is to find out which model produces the best results and is preferred by patients. Up to 1,000 HCV-infected PWID will participate in the study in eight sites around the country. Patients will be randomized into either the PN or the DOT groups. Patients who end up in the PN group will get a biweekly blister pack of medication to take home. Their PN will provide education and support. The investigators will find out whether patients adhered to medication using an electronic adherence monitoring system. Patients who are randomly assigned to the DOT group will take their medication in front of a staff member.

Eligibility Criteria

Inclusion Criteria

  • HCV infection
  • Actively injecting drugs (any substance within 3 months)
  • Not previously treated with HCV direct-acting antiviral medications
  • Age 18 - 70
  • Willing to receive HCV treatment with sofosbuvir/velpatasvir
  • Willing to be randomized to either PN vs mDOT
  • If receiving methadone, be attending methadone clinic a minimum of 5 times per week
  • Able to provide informed consent
  • English or Spanish fluency

Exclusion Criteria

  • Pregnant or breast feeding
  • Hepatocellular carcinoma
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02824640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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