NCT03387462

DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence

DOT Diary (D2): Developing a Mobile App With Combined Automated DOT and Daily Sexual Diary for Monitoring and Improving PrEP Adherence: DOT Diary Optimization Pilot

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Public Health Foundation Enterprises, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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 understand people's experiences using this new app while taking HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.

Detailed description

In the DOT Diary research project, the AiCure aDOT smartphone app has been adapted for use in monitoring and supporting HIV pre-exposure prophylaxis (PrEP) use among young men who have sex with men (YMSM). The aDOT app uses automated directly observed therapy (DOT) that use the smartphone camera and artificial intelligence software to confirm that the right person is taking the right medication at the right time. A sexual diary has been integrated into the aDOT app to assist YMSM in understanding whether they are receiving protection from PrEP for individual sexual episodes, and when it is particularly important to take PrEP (e.g. after a sexual episode). In the next stage of app development, the researchers are conducting this study to identify areas of the app that require refinement to maximize the acceptability and ease of use of the DOT adherence monitoring app. The researchers will assess overall acceptability and ease of use of the integrated DOT Diary (D2) app over an 8 week period.The goal of this pilot study will be to refine and optimize the app for further testing in a larger and longer pilot study among YMSM at risk for HIV acquisition. The researchers will conduct this pilot protocol among YMSM in Atlanta and San Francisco Bay Area, two metropolitan regions heavily impacted by HIV, yet differing in sociodemographics, as well as in the availability and uptake of HIV prevention services, including PrEP. These diverse research locations will allow collection of data to inform app development among a broad group of YMSM.

Conditions

• Adherence, Medication
• Risk Behavior
• Pre-Exposure Prophylaxis
• HIV Prevention

Interventions

Type	Name	Description
DRUG	Emtricitabine / Tenofovir Disoproxil Oral Tablet	Open label daily emtricitabine/tenofovir disoproxil oral tablet
OTHER	DOT Diary mobile app	DOT Diary mobile application for tracking medication adherence and sexual activities.

Timeline

• Start date: 2018-02-28
• Primary completion: 2018-08-30
• Completion: 2018-08-30
• First posted: 2018-01-02
• Last updated: 2021-10-27
• Results posted: 2020-02-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study