DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men

Phase 4 Completed 100 enrolled Public Health Foundation Enterprises, Inc. AiCure · collab Emory University · collab National Institute of Mental Health (NIMH) · collab San Francisco Department of Public Health · collab

RandomizedParallel-groupOpen-labelOther

Summary

The researchers are working with a technology company, AiCure, to develop a smartphone app, DOT Diary, which combines two drug adherence strategies. DOT Diary reminds people when it is time to take their medication, and uses motion-sensing technology to visually and automatically confirm the pill was swallowed. The goal of this study is to assess the impact of the app on adherence to HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.

Timeline

Start: 2019-02-01
Primary completion: 2020-04-21
Completion: 2020-04-21

Outcome

Missed primary endpoint

registry analysis (superiority test); DOT Diary Intervention vs DOT Diary Control; p = 0.94; Risk Ratio (RR) 1.01 (95% CI 0.75 to 1.36) NCT03771638 ↗

Publications

Velloza J, Liu AY, Katz AWK, van der Straten A, Siegler AJ, Scott H, Wilde G, Lockard A, Christie RH, Buchbinder SP. Acceptability of an automated directly observed therapy (DOT) application for PrEP adherence support among young men who have sex with men: a qualitative exploration. AIDS Care. 2024 Nov;36(11):1704-1718. doi: 10.1080/09540121.2024.2397133. Epub 2024 Sep 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenofovir disoproxil fumarate	Small molecule	—	Oral
Subject	emtricitabine	Other / unclassified	—	Oral

Indications

No indication recorded.