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

Author:

Buchbinder Susan P.ORCID,Siegler Aaron J.,Coleman Kenneth,Vittinghoff Eric,Wilde Gretchen,Lockard Annie,Scott Hyman,Anderson Peter L.,Laborde Nicole,van der Straten Ariane,Christie Richard H.,Marlborough Michelle,Liu Albert Y.

Abstract

AbstractMeasurement 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.

Funder

National Institute of Mental Health and Neurosciences

Publisher

Springer Science and Business Media LLC

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health,Social Psychology

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