Clinical trial

ID Cap System: Next Generation Ingestible Sensors for Medication Adherence Measurement

Name

2022P002497

Description

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.

Trial arms

Trial start

2023-02-20

Estimated PCD

2024-04-30

Trial end

2024-04-30

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

ART Participants, PrEP Participants

Other names:

Digital pill system

Truvada for pre-exposure prophylaxis (PrEP)

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

Arms:

PrEP Participants

Biktarvy for antiretroviral therapy (ART)

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

Arms:

ART Participants

Size

Primary endpoint

Feasibility of Next-Generation ID-Cap System to Measure PrEP/ART Adherence

Month 1 study visit

Correlation of PrEP/ART Adherence with DBS Concentrations and Pill Counts

Month 1 study visit

Acceptability of Next-Generation ID-Cap System, via System Usability Scale

Month 1 study visit

Acceptability of Next-Generation ID-Cap System, via Qualitative Interviews

Month 1 study visit

Eligibility criteria

Inclusion Criteria: 1. PrEP Participants: * Age 18 or older * HIV negative * Prescribed and currently taking Truvada for PrEP for at least 30 days * Qualifying labs for PrEP (Cr clearance in past 6 months, HBV vaccination, liver function tests) * Owns a smartphone with Android or iOS 2. ART Participants: * Age 18 or older * Diagnosed with HIV * Prescribed and taking Biktarvy for at least 6 months * Undetectable viral load during prior 6 months * Owns a smartphone with Android or iOS Exclusion Criteria: 1. PrEP Participants: * Does not speak English * History of Crohn's disease or ulcerative colitis * History of gastric bypass or bowel stricture * History of GI malignancy or radiation to abdomen * Allergy to gelatin, silver, or zinc * Implanted cardiac device, nerve stimulator, or drug infusion pump * Not willing to operate DPS 2. ART Participants: * Does not speak English * History of Crohn's disease or ulcerative colitis * History of gastric bypass or bowel stricture * History of GI malignancy or radiation to abdomen * Allergy to gelatin, silver, or zinc * Implanted cardiac device, nerve stimulator, or drug infusion pump * Not willing to operate DPS

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'For 30 days, the next-generation Reader and ID-Cap System will be used in an open-label, observational trial with N=30 participants (N=15 HIV-negative individuals on PrEP and N=15 PLWH on ART).', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2023-11-07

1 organization

2 products

6 indications

Organization

Brigham and Women's Hospital

Product

Truvada

Indication

HIV Infection

Indication