Next Generation Ingestible Sensors for Medication Adherence Measurement
Status:
Not yet recruiting
Trial end date:
2023-07-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Fenway Community Health
Collaborator:
Brigham and Women's Hospital
Treatments:
Anti-Retroviral Agents Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination