Directly Observed Therapy Accurately Measures PrEP Adherence

A smartphone application utilizing automated directly observed therapy (DOT) may be a better measurement of HIV pre-exposure prophylaxis (PrEP) adherence than the current standard of care among young men who have sex with men, a population at high-risk of HIV infection.

The smartphone application, DOT-Diary, combines automated DOT with an adherence visualization toolkit. The application included daily alarms as a reminder to take the dose, a diary to track sexual encounters, an estimated level of protection notification based on their recent record of pill-taking, and a small monetary incentive for taking the medication each day.

The randomized clinical trial included 100 men who have sex with men aged 18 to 35 years from two study sites (San Francisco, California and Atlanta, Georgia). Participants were randomized 2:1 to the intervention (n = 66) or the standard of care of self-reporting (n = 34). At baseline, week 12, and week 24 of follow-up, participants answered questions on their medical history and sexual practices, and the intervention group also answered questions on diary use and acceptability.

“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,” the authors wrote of their study results.

Additionally, no significant difference was observed between study arms in the proportion of patients with detectable medication levels at 24 weeks. Among the individuals randomized to the intervention, there was no substantial difference at week 12 vs week 24 in acceptability and ease of use of the smartphone application.

Limitations of the study include the limited patient population and use of two study sites. Improved app functionality, including user interface and app design, may improve engagement in future iterations of the app.

The researchers concluded, “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.”

Reference:

Buchbinder SP, Siegler AJ, Coleman K, et al. Randomized controlled trial of automated directly observed therapy for measurement and support of PrEP adherence among young men who have sex with men. AIDS Behav. 2023;27(2):719-732. doi:10.1007/s10461-022-03805-3.