ID-Cap™ System Will Allow Clinicians
to Remotely Track Ingestion Events and Provide Feedback to Patients
GAINESVILLE, Fla. (September 10, 2020) – Digital health company etectRx™, Inc. (etectRx™), today announced that its FDA-cleared ingestible event marker, the ID-Cap™ System, will be utilized in a clinical study of 60 patients to develop programs aimed to improve medication adherence in individuals taking the HIV prevention drug, TRUVADA (tenofovir/emtricitabine) for PrEP® (Pre-Exposure Prophylaxis).
Beginning this month, the study, named “PrEPsteps,” will utilize etectRx’s novel ID-Cap System to track patients’ ingestions and provide real-time feedback to address non-adherence. After doses are tracked via the ID-Cap System, patients will receive personalized messages from clinicians, either reinforcing confirmed ingestions, or checking on patients after a missed dose.
The NIH-sponsored study will be conducted in partnership with Brigham and Women’s Hospital in Boston and The Fenway Institute at Fenway Health, one of the preeminent LGBT health and HIV research organizations in the world. Brigham and Women’s Hospital selected etectRx as a partner for the study due to the high level of accuracy and reliable data offered by the ID-Cap System.
The study will be led by principal investigator, Dr. Peter Chai, M.D., M.M.S., toxicologist in the Department of Emergency Medicine at Brigham and Women’s Hospital; and assistant professor, Harvard Medical School.
“The PrEPsteps study is a milestone in both the research of HIV prevention, and the remote patient monitoring arena,” said Valerie Sullivan, president and CEO of etectRx. “As clinicians search for ways to accurately monitor patients remotely due to COVID-19 restraints, our ID-Cap System has emerged as a reliable, accurate and robust system, delivering the ability to confirm medication ingestion.”
PrEPsteps will build on findings from a previous “DigiPrEP” study at Brigham and Women’s Hospital that utilized the ID-Cap System to prove patient acceptance of TRUVADA for PrEP.
“The ability to track and influence medication adherence through tech-based solutions is a critical piece of the strategy to end the spread of HIV,” said Dr. Chai. “Coupled with the data gathered from the DigiPrEP study, PrEPsteps will give us valuable insights into how we can influence adherence and ultimately impact outcomes for our patients.”
Study participants will receive care at Fenway Health and will use the ID-Cap System for 90 days.
etectRx™ is a privately held digital health company that has a patented ingestible event marker, the ID-Cap™ System, that provides real-time, dose-level ingestion event verification. The ID-Cap System is used to track ingestion events that monitor and measure medication adherence to provide timely interventions for better patient engagement. For information on partnership opportunities with etectRx, click here.
ID-Cap System Indications for Use
The FDA-cleared, ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule, which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ID-Capsule, is desirable.
The NIH-sponsored clinical study described in this press release was supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) under Award Number R01AI145453. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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