Ingestible Electronic Sensors for Monitoring Real-time Adherence to HIV Pre-exposure Prophylaxis and Antiretroviral Therapy

Watanabe JH, McInnis T, Hirsch JD. Cost of prescription drug–related morbidity and mortality. Ann Pharmacother. 2018;52(9):829–37.

Article  Google Scholar 

Centers for Disease Control and Prevention. Ending the HIV epidemic in the U.S. [Internet]. 2022. Available from: https://www.cdc.gov/endhiv/index.html. Accessed 7/1/2022.

Spinelli M, Haberer J, Chai P, Castillo-Mancilla J, Anderson P, Gandhi M. Approaches to objectively measure antiretroviral medication adherence and drive adherence Interventions. Curr HIV/AIDS Rep. 2020;17(4):301–14.

Article  Google Scholar 

Dunn K, Lafeuille MH, Jiao X, Romdhani H, Emond B, Woodruff K, et al. Risk factors, health care resource utilization, and costs associated with nonadherence to antiretrovirals in Medicaid-insured patients with HIV. J Manag Care Spec Pharm. 2018;24(10):1040–51.

PubMed  Google Scholar 

Haberer JE, Bangsberg DR, Baeten JM, Curran K, Koechlin F, Amico KR, et al. Defining success with HIV pre-exposure prophylaxis: a prevention-effective adherence paradigm. AIDS. 2015;29(11):1277–85.

Article  Google Scholar 

Bell KM, Haberer JE. Actionable adherence monitoring: technological methods to monitor and support adherence to antiretroviral therapy. Curr HIV/AIDS Rep. 2018;15(5):388–96.

Article  Google Scholar 

Castillo-Mancilla JR, Haberer JE. Adherence measurements in HIV: new advancements in pharmacologic methods and real-time monitoring. Curr HIV/AIDS Rep. 2018;15(1):49–59.

Article  Google Scholar 

AARDEX Corporation. Medication Event Monitoring System (MEMS) [Internet]. Zug, Switzerland: AARDEX Corporation; 1984. Available from: https://www.aardexgroup.com/solutions/mems-adherence-hardware/.

Cross A, Gupta N, Liu B, Nair V, Kumar A, Kuttan R, et al. 99DOTS: a low-cost approach to monitoring and improving medication adherence. In: Proceedings of the Tenth International Conference on Information and Communication Technologies and Development [Internet]. Ahmedabad India: ACM; 2019 [cited 2022 Jun 6]. p. 1–12. Available from: https://dl.acm.org/doi/https://doi.org/10.1145/3287098.3287102.

Ikeda C, Misaki D. Medication monitoring from accelerometer data through a series of medication actions using neural network for medication adherence evaluation. In: 2022 IEEE International Conference on Big Data and Smart Computing (BigComp) [Internet]. Daegu, Korea, Republic of: IEEE; 2022 [cited 2022 Jun 6]. p. 288–91. Available from: https://ieeexplore.ieee.org/document/9736491/.

Kandori A, Yamamoto T, Sano Y, Oonuma M, Miyashita T, Murata M, et al. Simple magnetic swallowing detection system. IEEE Sens J. 2012;12(4):805–11.

Article  Google Scholar 

Bain EE, Shafner L, Walling DP, Othman AA, Chuang-Stein C, Hinkle J, et al. Use of a novel artificial intelligence platform on mobile devices to assess dosing compliance in a phase 2 clinical trial in subjects with schizophrenia. JMIR MHealth UHealth. 2017;5(2): e18.

Article  Google Scholar 

Kalantar-zadeh K, Ha N, Ou JZ, Berean KJ. Ingestible sensors. ACS Sens. 2017;2(4):468–83.

CAS  Article  Google Scholar 

Kalantar-Zadeh K, Berean KJ, Ha N, Chrimes AF, Xu K, Grando D, et al. A human pilot trial of ingestible electronic capsules capable of sensing different gases in the gut. Nat Electron. 2018;1(1):79–87.

Article  Google Scholar 

Chai PR, Carreiro S, Innes BJ, Rosen RK, O’Cleirigh C, Mayer KH, et al. Digital pills to measure opioid ingestion patterns in emergency department patients with acute fracture pain: a pilot study. J Med Internet Res. 2017;19(1): e19.

Article  Google Scholar 

Chai PR, Mohamed Y, Bustamante MJ, Goodman GR, Najarro J, Castillo-Mancilla J, et al. DigiPrEP: A pilot trial to evaluate the feasibility, acceptability, and accuracy of a digital pill system to measure PrEP adherence in men who have sex with men who use substances. JAIDS J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):e5–15. This work showed that the DPS was a feasible, acceptable, and accurate tool for measuring PrEP adherence among HIV-negative MSM with non-alcohol substance use.

Chai PR, Castillo-Mancilla J, Buffkin E, Darling C, Rosen RK, Horvath KJ, et al. Utilizing an ingestible biosensor to assess real-time medication adherence. J Med Toxicol. 2015;11(4):439–44.

CAS  Article  Google Scholar 

Chai PR, Goodman G, Bustamante M, Mendez L, Mohamed Y, Mayer KH, et al. Design and delivery of real-time adherence data to men who have sex with men using antiretroviral pre-exposure prophylaxis via an ingestible electronic sensor. AIDS Behav. 2021;25(6):1661–74.

Article  Google Scholar 

Chai PR, Mohamed Y, Goodman G, Bustamante MJ, Sullivan MC, Najarro J, et al. Development of a digital pill and respondent behavioral intervention (PrEPSteps) for HIV pre-exposure prophylaxis adherence among stimulant using men who have sex with men. Transl Behav Med. 2022;12(1):ibab117.

Food and Drug Administration. Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the ingestible event marker [Internet]. 2013 [cited 2022 Aug 19]. Available from: https://www.federalregister.gov/documents/2013/05/16/2013-11628/medical-devices-general-hospital-and-personal-use-monitoring-devices-classification-of-the.

U.S. Food and Drug Administration. 510(k) Premarket notification - Proteus patch [Internet]. 2014. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133263. Accessed 7/1/2022.

Otsuka America Pharmaceutical, Inc. Otsuka and Proteus® announce the first U.S. FDA approval of a digital medicine system: ABILIFY MYCITE® (aripiprazole tablets with sensor) [Internet]. Press Release. 2017 [cited 2022 Aug 19]. Available from: https://www.otsuka-us.com/discover/articles-1075.

Proteus Digital Health, Inc. Voluntary petition for non-individuals filing for bankruptcy [Internet]. 2020 [cited 2022 Jun 22]. Available from: https://storage.courtlistener.com/recap/gov.uscourts.deb.181708/gov.uscourts.deb.181708.1.0.pdf.

Otsuka America Pharmaceutical, Inc. Otsuka America Pharmaceutical, Inc., Purchases the Assets of Proteus Digital Health, Inc. [Internet]. Press Release. 2020 [cited 2022 Jun 28]. Available from: https://www.otsuka-us.com/discover/proteus-assets-purchase.

U.S. Food and Drug Administration. US FDA approval of ID-Cap system [Internet]. 2019. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183052.pdf. Accessed 7/1/2022.

Ibrahim ME, Brooks KM, Castillo-Mancilla JR, McHugh C, Morrow M, Brothers J, et al. Short communication: bioequivalence of tenofovir and emtricitabine after coencapsulation with the Proteus ingestible sensor. AIDS Res Hum Retroviruses. 2018;34(10):835–7.

CAS  Article  Google Scholar 

Chai PR, Pereira LM, Jambaulikar GD, Carrico AW, O’Cleirigh C, Mayer KH, et al. Short communication: bioequivalence of tenofovir component of tenofovir/rilpivirine/emtricitabine in digital pills. AIDS Res Hum Retroviruses. 2019;35(4):361–3.

CAS  Article  Google Scholar 

Liu H, Daar E, Wang Y, Siqueiros L, Campbell K, Shen J, et al. Pharmacokinetics of coencapsulated antiretrovirals with ingestible sensors. AIDS Res Hum Retroviruses. 2020 Jan 1;36(1):65–74. This study established the bioequivalence of coencapsulated BIC, FTC, and TAF in the BIC/FTC/TAF formulation.

Chai PR, Goodman G, Bustamante MJ, Mohamed Y, Castillo-Mancilla J, Boyer EW, et al. Long-term stability of the electronic sensor component of a digital pill system in real-world storage settings. J Pharm Technol. 2021;37(3):135–9.

Article  Google Scholar 

U.S. Food and Drug Administration. Guidance for industry: bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA center for drug evaluation and research [Internet]. 2013 [cited 2022 Jun 20]. Available from: https://www.fdanews.com/ext/resources/files/12/12-05-13-ANDAGuidance.pdf.

U.S. Food and Drug Administration. Analytical procedures and methods validation for drugs and biologics: guidance for industry [Internet]. 2015 [cited 2022 Jun 20]. Available from: https://www.fda.gov/files/drugs/published/Analytical-Procedures-and-Methods-Validation-for-Drugs-and-Biologics.pdf.

•• Goodman GR, Kikut A, Bustamante MJ, Mendez L, Mohamed Y, Shachar C, et al. “I’d feel like someone was watchin’ me… watching for a good reason”: perceptions of data privacy, access, and sharing in the context of real-time PrEP adherence monitoring among HIV-negative MSM with substance use. AIDS Behav [Internet]. 2022 Mar 18 [cited 2022 May 19]; Available from: https://doi.org/10.1007/s10461-022-03614-8. This work showed that prospective DPS users (HIV-negative MSM on or eligible for PrEP) desire robust data security measures to protect personal adherence data and were willing to share DPS adherence data with diverse individuals including primary care providers and long-term relationship partners.

Chai P, Bustamante M, Goodman G, Mohamed Y, Najarro J, Sullivan M, et al. A brief training program to support use of a digital pill system for medication adherence. JMIR Form Res. 2021;5(4): e26213.

Article  Google Scholar 

Browne S. Digital health feedback system (DHFS) for longitudinal monitoring of ARVs used in HIV pre-exposure prophylaxis (PrEP) [Internet]. ClinicalTrials.gov. 2018 [cited 2022 Jun 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT03693040.

Chai P. Development of Ingestible Biosensors to Enhance PrEP Adherence in substance users (PrEPSteps) [Internet]. ClinicalTrials.gov. 2018 [cited 2022 Jun 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT03512418.

etectRx®, Inc. etectRx Announces U.S. FDA clearance of novel ingestible event marker [Internet]. 2019. Available from: https://etectrx.com/etectrx-announces-u-s-fda-clearance-of-novel-ingestible-event-marker/. Accessed 7/1/2022.

Mayer KH, Safren SA, Elsesser SA, Psaros C, Tinsley JP, Marzinke M, et al. Optimizing pre-exposure antiretroviral prophylaxis adherence in men who have sex with men: results of a pilot randomized controlled trial of “Life-Steps for PrEP.” AIDS Behav. 2017;21(5):1350–60.

Article  Google Scholar 

Safren SA, W. Otto M, Worth JL, Salomon E, Johnson W, Mayer K, et al. Two strategies to increase adherence to HIV antiretroviral medication: life-steps and medication monitoring. Behav Res Ther. 2001 Oct;39(10):1151–62.

Davis FD. Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS Q. 1989;13(3):319–40.

Article  Google Scholar 

Venkatesh, Morris, Davis, Davis. User acceptance of information technology: toward a unified view. MIS Q. 2003;27(3):425.

Venkatesh V, Bala H. Technology acceptance model 3 and a research agenda on interventions. Decis Sci. 2008;39(2):273–315.

Article  Google Scholar 

Daar ES, Rosen MI, Wang Y, Siqueiros L, Shen J, Guerrero M, et al. Real‐time and wireless assessment of adherence to antiretroviral therapy with co‐encapsulated ingestion sensor in HIV-infected patients: a pilot study. Clin Transl Sci. 2020 Jan;13(1):189–94. This pilot study demonstrated the overall acceptance of a DPS and associated reminder text messages for ART adherence measurement, with some variability in reported satisfaction.

Kamal S, Rosen MI, Lazar C, Siqueiros L, Wang Y, Daar ES, et al. Perceptions of people living with HIV and HIV healthcare providers on real-time measuring and monitoring of antiretroviral adherence using ingestible sensors: a qualitative study. AIDS Res Treat. 2020;1(2020):1–10.

Google Scholar 

Browne S. DHFS for medication adherence support during hospital admissions for person living with HIV [Internet]. ClinicalTrials.gov. 2020 [cited 2022 Jun 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT04418037?term=ingestible+sensor&cond=HIV&cntry=US&draw=2&rank=2.

Castillo-Mancilla J. Quantification of tenofovir alafenamide adherence (QUANTI-TAF) [Internet]. 2019 [cited 2022 Jun 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT04065347?term=digital+pill&cond=HIV&cntry=US&draw=2&rank=2.

Gerke S, Minssen T, Yu H, Cohen IG. Ethical and legal issues of ingestible electronic sensors. Nat Electron. 2019;2(8):329–34. This work provides an overview of the ethical and legal considerations involved in the real-world implementation of ingestible electronic sensors, as it relates to patients, providers, and broader social issues.

Electronics N. Time to switch on to digital ethics. Nat Electron. 2019;2(8):315–315.

Article  Google Scholar 

Martani A, Geneviève LD, Poppe C, Casonato C, Wangmo T. Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects. BMC Med Ethics. 2020;21(1):3.

Article  Google Scholar 

de Miguel Beriain I, Morla González M. ‘Digital pills’ for mental diseases: an ethical and social analysis of the issues behind the concept. J Law Biosci. 2020 Jul 25;7(1):lsaa040.

Klugman CM, Dunn LB, Schwartz J, Cohen IG. The ethics of smart pills and self-acting devices: autonomy, truth-telling, and trust at the dawn of digital medicine. Am J Bioeth. 2018;18(9):38–47.

Article  Google Scholar 

Simon AE, Wu AW, Lavori PW, Sugarman J. Preventive misconception. Am J Prev Med. 2007;32(5):370–4.

Article  Google Scholar 

Pew Research Center. Mobile fact sheet [Internet]. 2021 [cited 2022 Jun 22]. Available from: https://www.pewresearch.org/internet/fact-sheet/mobile/.

留言 (0)

沒有登入
gif