Nonadherence to medication therapy results in significant morbidity and mortality across the world. In theUnited States, medication nonadherence results in $528 billion of annual costs to healthcare to manageconsequences associated with nonadherence including progression of chronic disease. For medicationregimens like HIV pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART), morbidity associated withnonadherence includes acquisition and transmission of HIV, opportunistic infections, and exacerbation ofchronic HIV related comorbidities. In order to understand adherence and mitigate nonadherence, new directadherence tools that confirm ingestion events are needed. Current indirect measures detect surrogateindicators of adherence like self-report, pill counting, or electronic adherence devices that detect the opening ofpill bottles. These methods suffer from recall bias and often provide an incomplete measure of adherence. Incontrast, direct measures, such as directly observed or video observed therapy that utilizes a clinician orhealthcare worker to visually confirm medication ingestion, can verify medication ingestion events. Yet, thesedirect methods are expensive, require personnel, and are therefore difficult to scale. Direct confirmation of drugconcentration in serum or hair may be used as evidence of medication adherence, but these methods requirespecialized analysis techniques and provide overall adherence which may overlook periods of suboptimaladherence. In response to the limitations of both indirect and direct measures of adherence, digital pills-aningestible radiofrequency emitter and gelatin capsule which over encapsulates the desired medication-represent a tool that can directly confirm medication ingestions and innovatively provide feedback to both theuser and care team. In 2019, etectRx received FDA 510K clearance for the ID-Cap, a digital pill system thatdirectly measures medication adherence in real-time. Through K23DA044874 and independent investigator-initiated research grants from Gilead Sciences, we have demonstrated the feasibility of using the ID-CapSystem among individuals to measure adherence to PrEP and opioids. During these investigations, wediscovered widespread interest among patients in optimizing the system by developing a wrist-borne wearableReader to collection adherence information from the digital pill. This Phase I SBIR therefore develops the next-generation ID-Cap System with a wrist-borne wearable reader. In Aim 1, we will miniaturize the current versionof the Reader and conduct laboratory testing to ensure all components are functional and acquire signal fromingested digital pills. Next, in Aim 2, we will conduct an open-label pilot demonstration trial to understand thereal-world usability of the next generation ID-Cap System among N=30 individuals on PrEP (N=15) and ART(N=15). Our benchmarks for success, the development of a miniaturized wrist-worn reader and demonstrationof usability in a clinical trial, will optimally position us to advance commercialization efforts at etectRx in thecontext of a Phase II SBIR.
Public Health Relevance Statement: PROJECT NARRATIVE
Nonadherence to medication regimens results in significant morbidity and mortality, especially among
individuals on HIV pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART). Digital pill systems
are a method to directly measure and confirm adherence and have been demonstrated as feasible in
the real-world, but user feedback has indicated that wearable devices linked to the digital pill system
need to be miniaturized. This grant develops a next-generation digital pill system (ID-Cap) with a wrist-
borne Reader to measure adherence to PrEP and ART.
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