CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 755 enrolled
Drug / intervention
Patient Navigation +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02824640
NCT02824640N/ACompleted

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

Prisma Health-Upstate·interventional·Posted Jul 7, 2016·Updated Sep 26, 2024

In Brief

A clinical study evaluating Patient Navigation and modified Directly Observed Therapy for Hepatitis C and Medication Adherence. Completed, enrolled 755 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 7, 2016
Enrollment StartSep 15, 2016
Primary CompletionMar 20, 2020
Study CompletionAug 4, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.0 years ago

Interventions

Patient Navigationbehavioral

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.

modified Directly Observed Therapybehavioral

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.