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NCT03127358 · ClinicalTrials.gov registry record · NA
Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs
A NA study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT03127358 is a NA study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 11 participants.
The verdict
NCT03127358, a NA study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study 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.
Interventions
- DEVICE AiCure
- DEVICE AiCure with gamification
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-11-14 |
| Est. Completion | 2019-02-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03127358
The ClinicalTrials.gov registry entry for NCT03127358 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AiCure is the first listed.
NCT03127358 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03127358 about?
NCT03127358 is a clinical study titled "Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs". 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 bee...
What is the current status of trial NCT03127358?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2017-11-14. Estimated completion is 2019-02-06.
What interventions are being tested in trial NCT03127358?
The interventions under investigation include: AiCure (DEVICE), AiCure with gamification (DEVICE).
Who is sponsoring clinical trial NCT03127358?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
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