Next Generation Ingestible Sensors for Medication Adherence Measurement

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.

Conditions

• HIV Infection
• Adherence, Medication
• Adherence, Treatment
• Pre-Exposure Prophylaxis
• Antiretroviral 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.

Sponsors & Collaborators

• The Fenway Institute

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Peter Chai, MD, MMS · Brigham and Women's Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-06

Primary Completion

2024-07-25

Completion

2024-07-25

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations