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

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.

Conditions

• Hepatitis C
• Medication Adherence

Interventions

BEHAVIORAL

Patient Navigation

The study will follow a PN model (Check Hep C) developed by NYCDOH in collaboration with Montefiore and the community. HCV PNs will provide the following interventions to those randomized to the PN arm: coordination of HCV treatment; health promotion; assisting patients to overcome barriers; and psychosocial support.

BEHAVIORAL

modified Directly Observed Therapy

Subjects will be observed taking medications, a minimum of 5 times a week for those enrolled in the OAT setting, and a minimum of 3 times a week for those enrolled in the community health clinic setting.

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• University of Rhode Island

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• West Virginia University

  collaborator OTHER

• University of New Mexico

  collaborator OTHER

• University of California

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Montefiore Medical Center

  collaborator OTHER

• Prisma Health-Upstate

  lead OTHER

Principal Investigators

• Alain Litwin, MD, MPH · Prisma Health-Upstate

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-15

Primary Completion

2020-03-20

Completion

2021-08-04

Countries

• United States

Study Locations