Evaluation of HepCure Toolkit to Improve Harvoni Adherence

NCT02740556 | Completed DMC

• 2 other identifiers: GCO 15-1273GS-IN-US-337-3933
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

There is limited data outside of clinical trials on adherence to once daily ledipasvir/sofosbuvir regimens. Many patients present with known barriers to medication adherence including untreated psychiatric illness and substance use disorders, cognitive impairment, and low health literacy. The goal of this study is to evaluate the baseline level of adherence to ledipasvir/sofosbuvir in a real-world clinic population and compare this to the level of adherence in patients provided with additional adherence support. Medication adherence in this study will be evaluated using AdhereTech, a wireless pill monitoring device that measures the dosage and time a medication was taken. Using cellular technology, AdhereTech can be used passively to collect data on when a medication is taken, when a refill is needed, and how often the bottle is opened. AdhereTech also can be used actively to monitor adherence and provide feedback to subjects using the device. When actively monitoring, AdhereTech can be set up to provide live feedback to a subject by lighting up, sounding chimes, and sending phone/text/email alerts to remind patients to take their medication (see attached PowerPoint presentation). HepCure is a web-based tool kit in the form of a dashboard for medical providers (MDs and NPs) and an application (or "app") for patients. The app allows patients to become active participants in their treatment by enabling them to set medication reminders, record doses taken, and communicate their adherence to their medical provider using the provider dashboard.

Conditions

Hepatitis C; Medication Adherence

Keywords

Hepatitis C; Adherence; Adheretech; HepCure; Telehealth; Health apps

Outcome Measures

Primary Outcomes (1)

• Medication Adherence

  AdhereTech bottles use sensors to provide a timestamp of when the bottle cap was open and closed.

  up to 9 months

Secondary Outcomes (1)

• HCV RNA

  up to 9 months

Study Arms (3)

AdhereTech Passive Monitoring

PLACEBO COMPARATOR

Patients not using the HepCure patient app while AdhereTech passively monitors adherence (no chimes or reminders).

Other: AdhereTech Passive Monitoring

HepCure Toolkit

EXPERIMENTAL

Patients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard with AdhereTech passively monitoring adherence (no chimes or reminders).

Other: HepCure ToolKit; Other: AdhereTech Passive Monitoring

HepCure Toolkit and AdhereTech Active Features

EXPERIMENTAL

Patients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard and with AdhereTech actively monitoring adherence (chimes and reminders enabled).

Other: HepCure ToolKit; Device: AdhereTech Active Features

Interventions

HepCure ToolKit OTHER

HepCure is a web-based tool kit in the form of a dashboard for providers and an application (or "app") for patients. The app allows patients to become active participants in their treatment by enabling them to enter prescribed treatment, add medications to "Pill Box," log doses, visualize adherence, and includes several additional resources.

HepCure Toolkit; HepCure Toolkit and AdhereTech Active Features

AdhereTech Active Features DEVICE

AdhereTech, a wireless pill monitoring device that measures the dosage and time a medication was taken. It is a HIPAA-compliant, FDA-registered Class I medical device. Using cellular technology, AdhereTech can be used passively to collect data on when a medication is taken, when a refill is needed, and how often the bottle is opened. AdhereTech also can be used actively to monitor adherence and provide feedback to subjects using the device. When actively monitoring, AdhereTech can be set up to provide live feedback to a subject by lighting up, sounding chimes, and sending phone/text/email alerts to remind patients to take their medication.

HepCure Toolkit and AdhereTech Active Features

AdhereTech Passive Monitoring OTHER

AdhereTech passively monitors adherence (no chimes or reminders)

AdhereTech Passive Monitoring; HepCure Toolkit

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age18 years and older
• Being prescribed Harvoni for treatment of HCV and not yet started treatment
• Speak and read English
• Possessing a smartphone device
• Ability to use a smartphone device
• Registered with a physician currently using the HepCure Provider Dashboard.
• Speak and read English

You may not qualify if:

• Individuals with diminished mental capacity who are unable to give informed consent
• Prisoners
• Participants who do not speak or write in English as a primary language
• Participants who are unable to speak and read English
• Participants who are expected to have difficult with regular access to smart phone device.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Gilead Sciences: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (11)

• Arnsten JH, Demas PA, Farzadegan H, Grant RW, Gourevitch MN, Chang CJ, Buono D, Eckholdt H, Howard AA, Schoenbaum EE. Antiretroviral therapy adherence and viral suppression in HIV-infected drug users: comparison of self-report and electronic monitoring. Clin Infect Dis. 2001 Oct 15;33(8):1417-23. doi: 10.1086/323201. Epub 2001 Sep 5.

  PMID: 11550118 BACKGROUND

• Bangsberg DR, Hecht FM, Charlebois ED, Zolopa AR, Holodniy M, Sheiner L, Bamberger JD, Chesney MA, Moss A. Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population. AIDS. 2000 Mar 10;14(4):357-66. doi: 10.1097/00002030-200003100-00008.

  PMID: 10770537 BACKGROUND

• Bangsberg DR, Hecht FM, Charlebois E, Chesney M, and Moss AR (2001a). Comparing objective methods of adherence assessment: electronic medication monitoring and unannounced pill count. AIDS Behav 5:275-281.

  BACKGROUND

• Bangsberg DR, Perry S, Charlebois ED, Clark RA, Roberston M, Zolopa AR, Moss A. Non-adherence to highly active antiretroviral therapy predicts progression to AIDS. AIDS. 2001 Jun 15;15(9):1181-3. doi: 10.1097/00002030-200106150-00015. No abstract available.

  PMID: 11416722 BACKGROUND

• Fennie KP, Bova CA, Williams AB. Adjusting and censoring electronic monitoring device data. Implications for study outcomes. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1:S88-95. doi: 10.1097/01.qai.0000248336.97814.2f.

  PMID: 17133208 BACKGROUND

• Gross R, Bilker WB, Friedman HM, Coyne JC, Strom BL. Provider inaccuracy in assessing adherence and outcomes with newly initiated antiretroviral therapy. AIDS. 2002 Sep 6;16(13):1835-7. doi: 10.1097/00002030-200209060-00021.

  PMID: 12218400 BACKGROUND

• Miller LG, Liu H, Hays RD, Golin CE, Beck CK, Asch SM, Ma Y, Kaplan AH, Wenger NS. How well do clinicians estimate patients' adherence to combination antiretroviral therapy? J Gen Intern Med. 2002 Jan;17(1):1-11. doi: 10.1046/j.1525-1497.2002.09004.x.

  PMID: 11903770 BACKGROUND

• Moss AR, Hahn JA, Perry S, Charlebois ED, Guzman D, Clark RA, Bangsberg DR. Adherence to highly active antiretroviral therapy in the homeless population in San Francisco: a prospective study. Clin Infect Dis. 2004 Oct 15;39(8):1190-8. doi: 10.1086/424008. Epub 2004 Sep 27.

  PMID: 15486844 BACKGROUND

• Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. doi: 10.7326/0003-4819-133-1-200007040-00004.

  PMID: 10877736 BACKGROUND

• Walsh JC, Pozniak AL, Nelson MR, Mandalia S, Gazzard BG. Virologic rebound on HAART in the context of low treatment adherence is associated with a low prevalence of antiretroviral drug resistance. J Acquir Immune Defic Syndr. 2002 Jul 1;30(3):278-87. doi: 10.1097/00126334-200207010-00003.

  PMID: 12131564 BACKGROUND

• Weiss JJ, Brau N, Stivala A, Swan T, Fishbein D. Review article: adherence to medication for chronic hepatitis C - building on the model of human immunodeficiency virus antiretroviral adherence research. Aliment Pharmacol Ther. 2009 Jul;30(1):14-27. doi: 10.1111/j.1365-2036.2009.04004.x. Epub 2009 Mar 26.

  PMID: 19416131 BACKGROUND

MeSH Terms

Conditions

Hepatitis C; Medication Adherence

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jeffrey J Weiss, PhD, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 15, 2016
• Study Start: February 1, 2016
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)