Individual Study / Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System

Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System

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

Population

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