Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs
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|ClinicalTrials.gov Identifier: NCT03127358|
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : January 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Medication Adherence||Behavioral: Automated Directly Observed Therapy Behavioral: Control, TAU||Not Applicable|
Automated DOT (a-DOT), a smartphone app that uses facial recognition software and advanced features to detect non-ingestion, combines the accuracy of in-person DOT with the convenience of real-time centralized data collection and monitoring. Adding a daily side effect diary to a-DOT will further allow precise tracking of timing of both medication ingestion and side effects which may be compromising adherence. Zepatier (elbasvir and grazoprevir) is a new once-daily fixe-dose combination tablet which has achieved high rates of SVR ranging from 94 to 97 percent in genotype-1 infected patients including those with HIV/HCV coinfection and renal impairment. Zepatier is administered for 12 to 16 weeks, depending on HCV genotype, prior treatment history, and the presence of certain baseline NS5A polymorphisms (1a only). By administering Zepatier via this innovative a-DOT platform, the investigators hypothesize that PWIDs treated in real-wrold settings can be successfully treated with high rates of adherence and SVR.
In this proposed 18-month trials, 75 PWIDs enrolled in opiate agonist treatment (genotypes 1a and 1b) with chronic HCV will be enrolled over a 12-month period, and randomized to either aDOT or treatment as usual (TAU). The investigators will recruit PWIDs from diverse community settings include a syringe exchange program (NYHRE), federally-qualified health center (Comprehensive Health Care Center), homeless shelter (The Living Room), and a methadone maintenance treatment program (Montefiore Wellness Centers). All patients (inlcuding treatment-experienced and HIVV/HCV coinfected subjects) will be treated with Zepatier-based regimens as per the standard of care. Rigorous data are necessary to judge the contribution of a-DOT to the success of HCV treatment in PWIDs. By performing a randomized trial of a-DOT HCV therapy (Zepatier with and without ribavirin), the investigators will evaluate the efficacy of a-DOT for improving HCV treatment outcomes among PWIDs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Smartphone Based Automated-Directly Observed Treatment Improves Adherence and SVR to Fixed-Dose Elbasvir and Grazoprevir in PWIDs: A Randomized Control Trial|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||September 1, 2018|
|Estimated Study Completion Date :||March 1, 2019|
Active Comparator: Intervention
Participants will use a-DOT technology to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12-16 weeks.
Behavioral: Automated Directly Observed Therapy
Participants will be randomized to either a-DOT or TAU. Participants randomized to the a-DOT group will receive treatment for HCV with Elbasvir-Grazoprevir using a cellphone app to monitor adherence, w
Placebo Comparator: Control
Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12-16 weeks.
Behavioral: Control, TAU
Participants in the control group (TAU), will receive treatment for HCV with Elbasvir-Grazoprevir as per standard of care.
- Sustained Viral Response (SVR) [ Time Frame: 12 weeks after treatment completion ]HCV viral load undecetable 12 weeks after treatment completion
- HCV Treatment Adherence [ Time Frame: 12-16 weeks ]Pill count
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127358
|Contact: Julia Arnsten, MDemail@example.com|
|United States, New York|
|Albert Einstein College of Medicine Division of Substance Abuse clinics||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Julia Arnsten, MD 718-944-3840 firstname.lastname@example.org|
|Principal Investigator: Julia Arnsten, MD|
|Principal Investigator:||Julia Arnsten, MD||Montefiore Medical Center|