Clinical trial NCT03387462: DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adherence, Medication
Risk Behavior
Pre-Exposure Prophylaxis
HIV Prevention
Keywords: Adherence
PrEP
HIV Prevention
Truvada
HIV Risk Reduction
Mobile App
Lead sponsor: Public Health Foundation Enterprises, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: San Francisco Department of Public Health
name: Emory University
name: AiCure
First posted: 2018-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Self-identifies as a man
* Age 18-35 at enrollment
* Reports having anal sex with a man or trans woman in the past 12 months and one or more of the following criteria in the past 12 months:

  * Any condomless anal sex (not in a mutually monogamous relationship with an HIV-negative partner)
  * Two or more anal sex partners
  * Self-reported STI (gonorrhea, chlamydia, syphilis)
  * Having a known HIV-positive sexual partner
* HIV-negative as determined by a negative 4th generation HIV test at screening and negative rapid 4th generation test at enrollment
* Currently taking PrEP or interested in initiating PrEP
* Eligible to take PrEP

  * Creatinine clearance ≥60 ml/min as estimated by Cockcroft-Gault equation at screening
  * Hepatitis B surface antigen (HBsAg) negative
* Willing and able to provide written informed consent
* Able to read and speak English
* Smartphone ownership compatible with DOT Diary
* Meets local locator requirements

Exclusion Criteria:

* Any reactive HIV test at screening or enrollment
* Signs or symptoms of acute HIV infection at screening or enrollment
* History of pathological bone fracture not related to trauma
* Taking nephrotoxic medications
* History of participation in the active arm of an HIV vaccine trial
* In a mutually monogamous sexual relationship with an HIV-negative partner for the past 12 months
* Does not live, work or play in Atlanta Metropolitan Area, San Francisco, Alameda, Marin, Contra Costa, Santa Clara, or San Mateo Counties
* Unable to commit to study participation for 8 weeks
* Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Primary outcomes:
measure: DOT Diary Mobile App Acceptability
timeFrame: 8 weeks
measure: DOT Diary Mobile App Ease of Use
timeFrame: 8 weeks
measure: Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP
timeFrame: 8 weeks
Secondary outcomes:
measure: Assessment of Situations and Reasons for Sub-optimal Use of the App
timeFrame: 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Bridge HIV, San Francisco Department of Public Health
state: California
city: Atlanta
country: United States
facility: Emory University, School of Public Health
state: Georgia
Study officials:
affiliation: Bridge HIV, San Francisco Department of Public Health
name: Susan Buchbinder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu AY, Laborde ND, Coleman K, Vittinghoff E, Gonzalez R, Wilde G, Thorne AL, Ikeguchi E, Shafner L, Sunshine L, van der Straten A, Siegler AJ, Buchbinder S. DOT Diary: Developing a Novel Mobile App Using Artificial Intelligence and an Electronic Sexual Diary to Measure and Support PrEP Adherence Among Young Men Who Have Sex with Men. AIDS Behav. 2021 Apr;25(4):1001-1012. doi: 10.1007/s10461-020-03054-2. Epub 2020 Oct 12.