Next Generation Ingestible Sensors for Medication Adherence Measurement

PHASE3CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

February 6, 2023

Primary Completion Date

July 25, 2024

Study Completion Date

July 25, 2024

Conditions
HIV InfectionAdherence, MedicationAdherence, TreatmentPre-Exposure ProphylaxisAntiretroviral Therapy
Interventions
DEVICE

Next-generation Reader and ID-Cap System

The digital pill system (DPS) is comprised of an ingestible radiofrequency emitter, integrated into a standard gelatin capsule, which then over-encapsulates the study medication (PrEP or ART). On ingestion, the radiofrequency emitter is activated by chloride ions in the stomach, projecting a signal approximately three feet off the body. This radio signal is acquired by a wearable device (Reader) which stores and forwards data to a smartphone, enabling on-demand access to adherence data. The next-generation Reader is a wrist-borne device.

DRUG

Truvada for pre-exposure prophylaxis (PrEP)

Participants will ingest one Truvada digital pill as PrEP per day, for 30 days total.

DRUG

Biktarvy for antiretroviral therapy (ART)

Participants will ingest one Biktarvy digital pill as ART per day, for 30 days total.

Trial Locations (1)

02215

Fenway Health, Boston

All Listed Sponsors
collaborator

The Fenway Institute

OTHER

lead

Brigham and Women's Hospital

OTHER