N/A
N=11
Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs
Hepatitis C · Medication Adherence
Bottom Line
View on ClinicalTrials.gov: NCT03127358 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: HCV Treatment Adherence — 83; 100; 88 percent of medication taken
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AiCure (Device); AiCure with gamification (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HCV Treatment Adherence |
83; 100; 88 | — |
| SECONDARY Number of Participants With HCV Treatment Completion |
3; 3; 5 | — |
| SECONDARY Number of Participants With Sustained Viral Response (SVR) |
100; 100; 100 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Known hypersensitivity (allergy) to elbasvir, grazoprevir, or ribavirin
- Pregnant or breast-feeding
Data sourced from ClinicalTrials.gov (NCT03127358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.