Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs

NCT03127358 | Completed Results FDA Device

• 1 other identifier: 2016-7215
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

People who Inject Drugs (PWIDs) constitute 60% of the approximately 5 million people in the United States infected with hepatitis C virus (HCV). Successful HCV treatment leading to sustained viral response (SVR) is associated with increased survival, but to date successful treatment of PWIDs has been limited. Treatment of PWIDs is complex due to addiction, mental illness, poverty, homelessness, lack of positive social support, poor adherence-related skills, low motivation and knowledge, and poor access to and trust in the health care system. At Albert Einstein College of Medicine, the investigators have developed a multidisciplinary model of HCV care that integrates on-site primary care, substance abuse treatment, and HCV-related care within opiate agonist treatment clinics. To optimize HCV treatment outcomes, the investigators have introduced directly observed therapy (DOT). In the DOT model, one daily dose of oral HCV medication is administered with methadone. However, DOT is not feasible for PWIDs who are not enrolled in methadone maintenance treatment programs, and is less effective for methadone-maintained PWIDs who do not attend the methadone clinics every day. In addition, DOT has been used for decades both to measure and maximize adherence for treatment of tuberculosis infection, but the cost and logistical complexity of administering DOT for large HCV clinical programs would be prohibitive.

Conditions

Hepatitis C; Medication Adherence

Keywords

Addiction; Sustained Viral Response; Adherence; Adverse Effects; Direct Acting Antiviral Agent; Chronic Hepatitis C; Resistance Development; Methadone Clinic; Primary Care; Directly Observed Therapy; Randomized Controlled Trial; Resistance; Reinfection; Treatment Outcome; Patient Navigation; Multi-Site; Liver Disease; Intervention

Outcome Measures

Primary Outcomes (1)

• HCV Treatment Adherence

  The amount of medication taken by each patient during the treatment period is expressed as a percentage (range 0-100%). Subjects will be classified as "adherent" if they receive at least 80% of the total dose of Zepatier. The numbers below denotes the mean percent of the medication the participants in each arm took.

  12 weeks

Secondary Outcomes (2)

• Number of Participants With HCV Treatment Completion

  12 weeks

• Number of Participants With Sustained Viral Response (SVR)

  12 weeks post treatment

Study Arms (3)

AiCure App

EXPERIMENTAL

Participants will use a-DOT technology called AiCure (a Smartphone App) to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks.

Device: AiCure

Treatment As Usual

NO INTERVENTION

Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks without using the AiCure app.

AiCure with gamification

ACTIVE COMPARATOR

Sub-group of participants will use a-DOT technology called AiCure (a Smartphone app) with gaming to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks. The gaming feature is to test whether competition encourages engagement and helps to increase adherence to the HCV medication.

Device: AiCure with gamification

Interventions

AiCure DEVICE

Smartphone App

Also known as: a-DOT, Smartphone App

AiCure App

AiCure with gamification DEVICE

Smartphone App with gaming.

Also known as: a-DOT with gamification

AiCure with gamification

Eligibility Criteria

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

You may qualify if:

• HCV-infected (HCV RNA test above the limit of quantification at baseline)
• Genotypes/Subtypes: G1a or G1b
• Eligible for HCV treatment per 2016 AASLD/IDSA guidelines
• Willing to receive HCV treatment on-site at DoSA clinics
• Health care provider decision to treat patient with Zepatier-based therapy with or without ribavirin based on 2016 AASLD/IDSA guidelines
• Using illicit drugs (either opiates, cocaine, or benzodizepenes) within the last 6 months
• Age 18 or older
• Able to provide informed consent
• English or Spanish speaking

You may not qualify if:

• Known hypersensitivity (allergy) to elbasvir, grazoprevir, or ribavirin
• Pregnant or breast-feeding

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• AiCure: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Albert Einstein College of Medicine Division of Substance Abuse clinics

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Hepatitis C; Medication Adherence; Behavior, Addictive; Hepatitis C, Chronic; Directly Observed Therapy; Reinfection; Liver Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Digestive System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Compulsive Behavior; Impulsive Behavior; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Recurrence

Limitations and Caveats

Early termination due to discontinued funding led to small numbers of subjects analyzed, and study personnel were no longer available to work on this study.

Results Point of Contact

• Title: Julia Arnsten, MD
• Organization: Albert Einstein College of Medicine

jarnsten@montefiore.org

718-920-6641

Study Officials

• Julia Arnsten, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 25, 2017
• Study Start: November 14, 2017
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: September 14, 2021
• Results First Posted: September 14, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)