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NCT02797262 · ClinicalTrials.gov registry record · NA
Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System
A NA study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 130
- Enrollment target
NCT02797262 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 130 participants.
The verdict
NCT02797262, a NA study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
Study Summary
Introduction of antiretroviral therapy (ART) has transformed HIV-infection from a fatal to manageable disease but adherence to ART remains critical to optimize outcomes. Existing measures of ART adherence provide only inferred measures of actual drug intake and most offer no real-time notification capability. Directly observed therapy measures actual drug intake but is not practical. These limitations constrain research into medication adherence and more importantly, limit our ability to develop real-time interventions based on feasible, in vivo monitoring of adherence among HIV-infected people to facilitate medication-taking. The Proteus digital health feedback (PDHF) system, a pill ingestible sensor based adherence measuring and monitoring system developed by Proteus Digital Health, addresses these limitations. It involves use of an ingestible sensor, a tiny edible material that is over-encapsulated along with prescribed medication. The sensor is activated by ingestion and is sensed by a patch worn by the patient with an embedded monitor and sensor. The monitor sends a Bluetooth signal to a mobile device, which in turn sends an encrypted message to a central server, thus effecting real-time monitoring that a dose has been taken. The investigators propose to develop a data receiving hub and add to these components an automated text message that is sent to the patient when a dose is missed. The investigators will evaluate the feasibility, acceptability and sustainability of using the PDHF system; assess the accuracy of the PDHF system in measuring adherence to ART; and evaluate the efficacy of the PDHF system for monitoring and leveraging adherence to ART.
Interventions
- DEVICE Proteus digital health feedback (PDHF) system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2015-09 |
| Est. Completion | 2020-10-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02797262
The ClinicalTrials.gov registry entry for NCT02797262 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Proteus digital health feedback (PDHF) system is the first listed.
NCT02797262 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02797262 about?
NCT02797262 is a clinical study titled "Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System". Introduction of antiretroviral therapy (ART) has transformed HIV-infection from a fatal to manageable disease but adherence to ART remains critical to optimize outcomes. Existing measures of ART adherence provide only inferred measures of actual drug intake and most offer no real-time notification c...
What is the current status of trial NCT02797262?
This trial is currently completed. It is a NA study. The enrollment target is 130 participants. The study started on 2015-09. Estimated completion is 2020-10-15.
What interventions are being tested in trial NCT02797262?
The interventions under investigation include: Proteus digital health feedback (PDHF) system (DEVICE).
Who is sponsoring clinical trial NCT02797262?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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