Georgia R Goodman1,2,3, Clint Vaz1,4, Hannah Albrechta2, Edward W Boyer5, Kenneth H Mayer2,6, Conall O'Cleirigh2,3, Peter R Chai7,8,9,10. 1. Department of Emergency Medicine, Brigham and Women's Hospital, 75 Francis St., Boston, MA, 02115, USA. 2. The Fenway Institute, Fenway Health, Boston, MA, USA. 3. Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA. 4. Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, MA, USA. 5. The Ohio State University Wexner Medical Center, Columbus, OH, USA. 6. Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical, Boston, MA, USA. 7. Department of Emergency Medicine, Brigham and Women's Hospital, 75 Francis St., Boston, MA, 02115, USA. pchai@bwh.harvard.edu. 8. The Fenway Institute, Fenway Health, Boston, MA, USA. pchai@bwh.harvard.edu. 9. Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, MA, USA. pchai@bwh.harvard.edu. 10. The Koch Institute for Integrated Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA. pchai@bwh.harvard.edu.
Abstract
PURPOSE OF REVIEW: This review summarizes the recent advancements and future directions of digital pill systems (DPS) - which utilize ingestible sensors to directly measure medication ingestion events in real-time - in the context of HIV prevention and treatment. RECENT FINDINGS: Two DPS are cleared by the US Food and Drug Administration. The bioequivalence and stability of digitized pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) have been established, and pilot studies have demonstrated the feasibility and acceptability of using DPS for PrEP and ART adherence measurement. Important bioethical and implementation considerations have been identified for future clinical trials. Continued technological advancement may reduce barriers to use, and integration of DPS into behavioral interventions may facilitate adherence improvement efforts. DPS represent an innovative tool for PrEP and ART adherence measurement. Future work will optimize the technology to reduce operational barriers. DPS have significant potential for expansion across a diverse array of diseases, though key bioethical considerations must be examined prior to large-scale implementation.
PURPOSE OF REVIEW: This review summarizes the recent advancements and future directions of digital pill systems (DPS) - which utilize ingestible sensors to directly measure medication ingestion events in real-time - in the context of HIV prevention and treatment. RECENT FINDINGS: Two DPS are cleared by the US Food and Drug Administration. The bioequivalence and stability of digitized pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) have been established, and pilot studies have demonstrated the feasibility and acceptability of using DPS for PrEP and ART adherence measurement. Important bioethical and implementation considerations have been identified for future clinical trials. Continued technological advancement may reduce barriers to use, and integration of DPS into behavioral interventions may facilitate adherence improvement efforts. DPS represent an innovative tool for PrEP and ART adherence measurement. Future work will optimize the technology to reduce operational barriers. DPS have significant potential for expansion across a diverse array of diseases, though key bioethical considerations must be examined prior to large-scale implementation.