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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: Completed NA study, sponsored by University of California, Los Angeles.
NCT02797262 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 130 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adherence to antiretroviral therapy (ART) measured by Proteus digital health feedback (PDHF) system for 16 weeks, including percent of prescribed medication taken.
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 |
What the finished NCT02797262 record still lists
NCT02797262 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Proteus digital health feedback (PDHF) system is the first listed.
NCT02797262 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02797262's enrollment target sits among peer trials
130 733rd of 2000 higher than 1,257 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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