Randomized Controlled Trial of Automated Directly Observed Therapy for Measurement and Support of PrEP Adherence Among Young Men Who have Sex with Men

• Type of Material: Article
• Authors: Susan P Buchbinder, San Francisco Department of Public Health; Aaron Siegler, Emory University; Kenneth Coleman, San Francisco Department of Public Health; Eric Vittinghoff, University of California, San Francisco; Gretchen Wilde, Emory University; Annie Lockard, Emory University; Hyman Scott, San Francisco Department of Public Health; Peter L Anderson, University of Colorado Anschutz Medical Campus; Nicole Laborde, Independent Consultant, San Rafael, USA; Ariane van der Straten, University of California San Francisco; Richard H Christie, AiCure; Michelle Marlborough, AiCure; Albert Y Liu, San Francisco Department of Public Health
• Language: English
• Date: 2023-02-01
• Publisher: Springer Nature
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s) 2022
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1007/s10461-022-03805-3
• Title of Journal or Parent Work: AIDS and Behavior
• Volume: 27
• Issue: 2
• Start Page: 719
• End Page: 732
• Grant/Funding Information: This research was supported by a Grant from National Institute of Mental Health and Neurosciences, R01MH109320.
• Keywords: Tenofovir; Artificial intelligence (AI); Adherence; Men who have sex with men (MSM); Male; HIV Infections; Homosexuality, Male; Anti-HIV Agents; Medication Adherence; Directly Observed Therapy; Pre-exposure prophylaxis (PrEP); Sexual and Gender Minorities; Directly observed therapy (DOT); Humans; Pre-Exposure Prophylaxis
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, Epidemiology

Abstract

Measurement of adherence to oral pre-exposure prophylaxis (PrEP) in real-time has been challenging. We developed DOT Diary, a smartphone application that combines automated directly observed therapy with a PrEP adherence visualization toolkit, and tested its ability to measure PrEP adherence and to increase adherence among a diverse cohort of young men who have sex with men (MSM). We enrolled 100 MSM in San Francisco and Atlanta and randomly assigned them 2:1 to DOT Diary versus standard of care. Concordance between DOT Diary measurement and drug levels in dried blood spots was substantial, with 91.0% and 85.3% concordance between DOT Diary and emtricitabine-triphosphate and tenofovir-diphosphate, respectively. There was no significant difference in the proportion of participants with detectable PrEP drug levels at 24 weeks between study arms. These results suggest DOT Diary is substantially better than self-reported measures of adherence, but additional interventions are needed to improve PrEP adherence over time.