The Patient-Reported Outcomes Project of HCV-TARGET

Completed

Conditions studied: Hepatitis C, Chronic, Liver Diseases

In brief

The PROP UP research study is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate all-oral treatment regimens for chronic hepatitis C viral (HCV) infection regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups. Participants will be recruited from 9 U.S. liver centers. Approximately 1920 patients with HCV infection who are prescribed a regimen containing Sofosbuvir/Ledipasvir(SOF/LED), SOF/Velpatasvir(SOF/VEL), Grazoprevir/Elbasvir(GRZ/ELB), OBV/PTV/r + DSV (PRoD), or daclatasvir/SOF (DAC/SOF) will be recruited and approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. PRO surveys will be evaluated before, during and after HCV treatment. PROP UP is a collaborative effort between behavioral and biomedical researchers, a patient engagement group and a patient advocacy organization.

Key facts

Study ID

NCT02601820

Run by

University of North Carolina, Chapel Hill

People needed

1601

Starts

2015-11-01

Expected to finish

2018-07-01

Last updated by the study team

2019-09-16

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with HCV genotype 1-6
• English-speaking
• Age 21 or older
• Medically cleared and being prescribed one of the following DAA regimens:
• sofosbuvir/ledipasvir (SOF/LED) with or without ribavirin
• ombitasvir/paritaprevir/ritonavir with dasabuvir (PRoD), with or without ribavirin
• elbasvir/grazoprevir (ELB/GRZ) with or without ribavirin
• daclatasvir/sofosbuvir, with or without ribavirin (DAC/SOF)
• sofosbuvir/velpatasvir (SOF/VEL)

You may not qualify if…

• Inability to provide written informed consent
• Currently participating in a pharmaceutical-sponsored drug trial of hepatitis C treatment
• Major cognitive or mental impairment
• Unable to read or speak English
• Unwilling or unable to complete survey questionnaires

Where it is running

• University of California at Davis — Davis, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Rush University — Chicago, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• St Louis University — St Louis, Missouri, United States
• Asheville Gastroenterology Associates — Asheville, North Carolina, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Wilmington Gastroenterology Associates — Wilmington, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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