Patient-Centered Models of HCV Care for People Who Inject Drugs
Completed · Not applicable
Conditions studied: Hepatitis C, Medication Adherence
In brief
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.
Key facts
- Study ID
- NCT02824640
- Run by
- Prisma Health-Upstate
- People needed
- 755
- Starts
- 2016-09-15
- Expected to finish
- 2021-08-04
- Last updated by the study team
- 2024-09-26
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Pregnant or breast feeding
- Hepatocellular carcinoma
Where it is running
- Alain Litwin — The Bronx, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.