Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System
Initiatives
-
To evaluate the feasibility, acceptability and sustainability of using the PDHF system; assess the accuracy of the PDHF system (an ingestible pill) in measuring adherence to ART; and evaluate the efficacy of the PDHF system for monitoring and leveraging adherence to ART.
- Start Year
- 2014
- Funding
- University of California, Los Angeles
Design
- Study design
- Clinical trial cohort
Marker Paper
https://clinicaltrials.gov/ct2/show/NCT02797262
PUBMED
Recruitment
- Sources of Recruitment
-
- Individuals
Number of participants
- Number of participants
- 165
- Number of participants with biosamples
Access
Availability of data and biosamples
| Data | |
| Biosamples | |
| Other |
Supplementary Information
De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.
Timeline
HIV-infected individuals
Inclusion Criteria:
HIV-infected individuals in HIV care
greater than 17 years of age
demonstrated ability to take over-encapsulated ARVs at time of screening; able to provide informed consent
On ART with sub-optimal adherence estimated by either patient (self-reports < 90% adherence over last 28 days) or treating clinician (e.g., based on gaps in treatment (e.g., missed appointments) or viral load elevations within last 6 months).
Selection Criteria
- Minimum age
-
17
- Newborns
- Twins
- Countries
-
- United States of America
- Ethnic Origin
-
- Health Status
-
- Other criteria
- Exclusion Criteria: Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal, risky or threatening behavior
Recruitment
- Sources of recruitment
-
- Specific population
Number of participants
- Number of participants
- 161
- Number of participants with biosamples
Data Collection Event
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.
- Start Date
-
2015-09
- End Date
-
2020-07
- Data sources
-
-
Smart sensors
- Ingestible sensors
-
Smart sensors