Digimeds to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence

Status unconfirmed · Not applicable

Conditions studied: Hepatitis C, Chronic, Nonadherence, Patient

In brief

This study evaluates the ability of digital medicines, Proteus Discover, to promote adherence and thus achieving a cure for hepatitis C in patients at high risk for not adhering to their hepatitis therapy. In this single-arm, prospective study, subjects at high risk for nonadherence will be prescribed hepatitis C therapy that will be co-encapsulated with ingestible sensors (creating the digital medicine) by a pharmacy. Both the subject and the providers will have access to the ingestion adherence.

Key facts

Study ID

NCT03164902

Run by

Proteus Digital Health, Inc.

People needed

253

Starts

2017-07-21

Expected to finish

2019-04-30

Last updated by the study team

2018-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A subject must meet ALL of the following criteria to be considered for enrollment into this study:
• Adults (≥18 years old) who are diagnosed with hepatitis C deemed chronic by the investigator
• Candidate for treatment for oral direct acting agent for hepatitis C such as fixed-dose velpatasvir and sofosbuvir; fixed-dose ledipasvir and sofosbuvir; or fixed-dose glecaprevir and pibrentasvir with insurance coverage for therapy. Subjects may take other medicines that will not be co-encapsulated (e.g. ribavirin)
• One of more of the following risk factors for nonadherence:
• Active alcohol or substance abuse (positive urine drug screen, illicit use in past 3 months, and/or in opioid substitution program), OR
• Patient reported history of hospitalization within past 2 years for a psychiatric comorbidity, OR
• Evidence of nonadherence to medications (e.g. self-report or refill history indicative of nonadherence), OR
• History of at least one missed clinic visit for hepatitis management, OR
• Patient-reported history of one or more transportation barriers (e.g. burden due to time and/or distance or lack of access to regular transportation) to healthcare access, which creates a risk for missed or delayed care
• Study subject has daily access to a telephone for communicating with the study personnel and study personnel contacting the study subject
• Ability to read and understand the instructions for the study.
• Willingness to adhere to all study procedures (both onsite and offsite), including troubleshooting of the product by a third-party, if needed.
• Capacity to and willing to provide informed consent. All subjects must have a signed informed consent document prior to participating in this study
• Currently owns and uses a smart phone or tablet, or has capacity to learn use of study mobile device as determined by investigator.
• Adequate data connectivity at home via cellular service and/or access to a secure wireless internet (WiFi) network with the proficiency to connect a mobile device to the WiFi network.
• Note: None of the five individual sub-criteria (i.e., 3a, 3b, 3c, 3d, or 3e) alone may be used to qualify more than approximately 20% of the total study population for randomization. For example, "3d" may be used to qualify no more than 20% of the study population for randomization without an additional sub-criteria also being met (e.g., "3d" + "3a"). The data center will monitor the use of these five enrolment sub-criteria, and study sites will be notified when qualification for enrollment may no longer be based upon meeting only a specific one of the five sub-criteria alone (e.g., "3d" alone).

You may not qualify if…

• ANY 1 of the following will exclude a subject from being enrolled into the study:
• BMI > 40 kg/m2 2. Active skin infection or active dermatitis, OR history of chronic inflammatory skin condition including psoriasis and chronic dermatitis (except atopic dermatitis) 3. Allergy to adhesive bandages/tapes (e.g. Band-Aids®) 4. Severely decompensated cirrhosis (Child-Pugh C) or a liver transplant candidate 5. Any condition that in the investigator's opinion could preclude safe participation in the study (e.g. contraindication to hepatitis C therapy) or would preclude the subject from being able to participate in the study protocol requirements 6. Participating in a drug study or medical device clinical study (including its safety follow-up period as defined by protocol) 30 days prior to study start or completion 7. Unwilling to take a gelatin capsule because it is manufactured from animal origins (e.g. for religious reasons) 8. Allergy to food dye 10. Terminal illness (≤ 1 year of life anticipated). 10. Currently known to be pregnant or nursing an infant. 11. For women of childbearing potential, not using an acceptable form of contraception for at least 2 months prior to screening and throughout the duration of the study. Accepted means of contraception include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy.
• Positive pregnancy test during screening 13. Inability to swallow the test capsule

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Zuckerberg San Francisco General Hospital — San Francisco, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Denver Health — Denver, Colorado, United States
• Providence Health System — Washington D.C., District of Columbia, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Apex Clinical Research — Tampa, Florida, United States
• The Ruth M. Rothstein CORE Center — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• The Research Institute — Springfield, Massachusetts, United States
• Harper University Hospital — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Southwest Care Center — Santa Fe, New Mexico, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Harborview Medical Center — Seattle, Washington, United States
• SSM Health Dean Medical Group — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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