drugset / Trial / NCT05592613

Next Generation Ingestible Sensors for Medication Adherence Measurement

NCT05592613

Non-randomizedParallel-groupOpen-labelOther

Summary

This study will investigate the use of a next-generation Reader as part of a digital pill system (DPS; ID-Cap System) to measure adherence to both antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) in people living with HIV (PLWH) and HIV-negative individuals, respectively. During the first (non-human subjects) component of this study, we developed a wrist-borne Reader according to design specifications and preferences shared by DPS users from our previous studies. Early bench testing by etectRx (manufacturer of the ID-Cap System) demonstrated that the wrist-borne version of the Reader acquires signal from the digital pill. This study will therefore evaluate the usability of and user response to a wrist-borne Reader component of the DPS among PLWH on ART and HIV-negative individuals on PrEP.

Timeline

Start
2023-02-06
Primary completion
2024-07-25
Completion
2024-07-25

Drugs

EvaluationDrugModalityDoseRoute
Background Biktarvy Other / unclassified
Background Tenofovir Small molecule