The Patient-Reported Outcomes Project of HCV-TARGET

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 21 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: hepatitis C, hep c
Type: Patient Registry
Target:
200 Participants
Investigator:
Description
This study is called “PROP UP.” The research team includes patients affected by Hep C, a Hep C patient advocacy organization, and researchers. Over 1920 patients with Hep C will be invited to participate. Patients will be recruited from 9 liver centers across the U.S. and will be asked to complete surveys before, during and after Hep C treatment.

With the information collected on these surveys, the researchers can better answer the following questions:
(a) What types of symptoms do patients with Hep C experience?
(b) Do these symptoms go away or lessen if cured from Hep C?
(c) What type of side effects do patients experience on different treatments or do patients feel better on treatment?
(d) Does patient functioning and well-being change during and after treatment?
(e) What are the longer-term benefits and harms of treatment?
(f) Are there differences in how well patients take their pills on different treatments?
(h) Do different kinds of patients report different experiences during and after treatment?
You are being invited to be in the study because you have Hepatitis C and your liver provider plans to prescribe you treatment for Hepatitis C soon.
This study requires

If you decide to take part in this study, you will complete the following:

1) Review and sign a consent form and a HIPAA form.

2) Respond to several survey questionnaires. They will be collected and stored in a private and secure research database.

3) Provide your contact information to be contacted via email or phone to complete the surveys each time.

4) Allow the research team to gather information from your electronic medical records. This information is related to Hep C, liver disease, HIV antibody, and HCV treatment.

Your responses to these surveys will be kept confidential and stored and protected in a safe and secure research database. The database is called REDCap (http://project- redcap.org/). REDCap is a mature, secure web application for managing online databases for research studies.

The information will be entered into the research database directly by you or the study research staff.

The study only observes patients’ experiences over time on Hep C treatment. Your liver provider will provide your medical care during Hep C treatment.

Who can participate

Inclusion Criteria

  1. Diagnosed with chronic HCV, any genotype 1-6
  2. English-speaking
  3. Age 21 or older
  4. Medically cleared and being prescribed one of the following DAA regimens: a. sofosbuvir/ledipasvir (Harvoni®) with or without ribavirin b. ombitasvir/paritaprevir/ritonavir with dasabuvir (Viekera Pak®), VPK) with or without ribavirin c. elbasvir/grazoprevir (Zepatier®) with or without ribavirin d. daclatasvir/sofosbuvir, with or without ribavirin (DAC/SOF) e. sofosbuvir/velpatasvir (SOF/VEL)

Exclusion Criteria

  1. Inability to provide written informed consent
  2. Currently participating in a pharmaceutical-sponsored drug trial of hepatitis C treatment
  3. Major cognitive or mental impairment
  4. Unable to read or speak English
  5. Unwilling or unable to complete survey questionnaires Pregnant and breastfeeding women are not treated with antiviral medications due to teratogenic effects, and therefore will not be included in the study population.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefit to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with this research study.
Compensation
We will compensate you after you complete the survey packets at each of the 5 time points during the study for your time and effort:
• $25 to complete surveys before treatment begins (within 90 days prior to starting treatment)
• $25 to complete surveys at week 4 during Hep C treatment
• $25 to complete surveys during the last 2 weeks of Hep C treatment
• $40 to complete surveys 3 months after Hep C treatment ends (12 weeks +/- 3 after treatment ends)
• $40 to complete surveys 12 months after Hep C treatment ends (12 months +/- 2 after treatment ends)
Resources
Schedule
Study duration and period
You will be in this research study for 15 - 20 months depending on how long your treatment lasts.
Recruitment period
From April 18, 2016
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Sophia Zaragoza
Research Topic
Conditions:
  • Hepatitis C, Chronic
  • Liver Diseases

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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