PMID- 36484300 OWN - NLM STAT- MEDLINE DCOM- 20230110 LR - 20240214 IS - 1537-6591 (Electronic) IS - 1058-4838 (Print) IS - 1058-4838 (Linking) VI - 76 IP - 1 DP - 2023 Jan 6 TI - Supporting the Art: Medication Adherence Patterns in Persons Prescribed Ingestible Sensor-enabled Oral Pre-Exposure Prophylaxis to Prevent Human Immunodeficiency Virus Infection. PG - 134-143 LID - 10.1093/cid/ciac280 [doi] AB - BACKGROUND: Timely, accurate adherence data may support oral pre-exposure prophylaxis (PrEP) success and inform prophylaxis choice. We evaluated a Food and Drug Administration (FDA)-approved digital health feedback system (DHFS) with ingestible-sensor-enabled (IS) tenofovir-disoproxil-fumarate plus emtricitabine (Truvada(R)) in persons starting oral PrEP. METHODS: Human immunodeficiency virus (HIV)-negative adults were prescribed IS-Truvada(R) with DHFS for 12 weeks to observe medication taking behavior. Baseline demographics, urine toxicology, and self-report questionnaires were obtained. Positive detection accuracy and adverse events were computed as percentages, with Kaplan Meier Estimate for persistence-of-use. In participants persisting >/=28 days, adherence patterns (taking and timing) were analyzed, and mixed-effects logistic regression modeled characteristics associated with treatment adherence. RESULTS: Seventy-one participants were enrolled, mean age 37.6 years (range 18-69), 90.1% male, 77.5% White, 33.8% Hispanic, 95.8% housed, and 74.6% employed. Sixty-three participants (88.7%) persisted >/=28 days, generating 4987 observation days, average 79.2 (29-105). Total confirmed doses were 86.2% (95% confidence interval [CI] 82.5, 89.4), decreasing over time, odds ratio (OR) 0.899 (95% CI .876, .923) per week, P < .001; 79.4% (95% CI 66.7%, 87.3%) of participants had >/=80% adherence. Pattern analysis showed days without confirmed doses clustered (P = .003); regular dose timing was higher among participants with >/=80% confirmed doses (0.828, 95% CI .796 to .859) than among those with <80% (0.542, 95% CI95 .405 to .679) P < .001. In multi-predictor models, better adherence was associated with older age, OR 1.060 (95% CI 1.033, 1.091) per year, P < .001; negative vs positive methamphetamine screen, OR 5.051 (95% CI 2.252, 11.494), P < .001. CONCLUSIONS: DHFS with IS-Truvada(R) distinguished adherent persons from those potentially at risk of prophylactic failure. Ongoing methamphetamine substance use may impact oral PrEP success. CI - (c) The Author(s) 2022. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. FAU - Browne, Sara H AU - Browne SH AD - Division of Infectious Diseases and Global Public Health, University of California San Diego, La Jolla, California, USA. AD - Specialists in Global Health, Encinitas, California, USA. FAU - Vaida, Florin AU - Vaida F AD - Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California, USA. FAU - Umlauf, Anya AU - Umlauf A AD - Department of Psychiatry, University of California San Diego, La Jolla, California, USA. FAU - Tucker, Amanda J AU - Tucker AJ AD - Division of Infectious Diseases and Global Public Health, University of California San Diego, La Jolla, California, USA. FAU - Blaschke, Terrence F AU - Blaschke TF AD - Department of Medicine, Stanford University, Stanford, California, USA. FAU - Benson, Constance A AU - Benson CA AD - Division of Infectious Diseases and Global Public Health, University of California San Diego, La Jolla, California, USA. LA - eng GR - R01 MH110057/MH/NIMH NIH HHS/United States GR - MH110057/MH/NIMH NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PL - United States TA - Clin Infect Dis JT - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JID - 9203213 RN - 0 (Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination) RN - 0 (Anti-HIV Agents) RN - G70B4ETF4S (Emtricitabine) RN - 44RAL3456C (Methamphetamine) SB - IM MH - Adult MH - Male MH - Humans MH - Adolescent MH - Young Adult MH - Middle Aged MH - Aged MH - Female MH - Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination MH - *Pre-Exposure Prophylaxis MH - *Anti-HIV Agents MH - *HIV Infections/drug therapy/prevention & control MH - Emtricitabine/therapeutic use MH - Medication Adherence MH - *Methamphetamine MH - Homosexuality, Male PMC - PMC10202440 OTO - NOTNLM OT - HIV prophylaxis OT - adherence OT - ingestible-sensor OT - real-time patterns COIS- Potential conflicts of interest. C. A. B. serves as an expert consultant for NDA Partners, Inc. C. A. B. is the Director of the UCSD Anti-viral Research Center (AVRC) and receives grant/contract support from Gilead for the conduct of a clinical trial (paid to institution). C. A. B. holds a leadership or fiduciary role on CROI Foundation Board and IAS-USA Board, both unpaid. T. F. B. serves as a member of the Board of Directors of Durect Corporation (Cupertino, California), as a scientific advisor to the Guthy Jackson Charitable Foundation (Beverly Hills, California, USA), and as an education advisor to UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI). T. F. B. also serves or has served as an expert consultant for NDA Partners, LLC., Merck, and for the Bill and Melinda Gates Foundation. A. J. T. serves as an expert consultant for RAND bioPartners, Inc. A. U. reports payment as Lecturer for University of California of San Diego (01/2020-06/2020; 01/2021-06/2021; 01/2022-03/2022). F. L. and S. H. B. report contracts or grants unrelated to this work from the NIH (NIH grant number R01MH110057; UCSD (Sara Browne, PI)). All the above authors state that none of these activities represent any conflicts or competing interests relevant to this research effort. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. EDAT- 2022/12/10 06:00 MHDA- 2023/01/11 06:00 PMCR- 2023/05/23 CRDT- 2022/12/09 05:33 PHST- 2021/11/24 00:00 [received] PHST- 2022/12/10 06:00 [pubmed] PHST- 2023/01/11 06:00 [medline] PHST- 2022/12/09 05:33 [entrez] PHST- 2023/05/23 00:00 [pmc-release] AID - 6588129 [pii] AID - ciac280 [pii] AID - 10.1093/cid/ciac280 [doi] PST - ppublish SO - Clin Infect Dis. 2023 Jan 6;76(1):134-143. doi: 10.1093/cid/ciac280.