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

In the DOT Diary research project, the AiCure automated directly observed therapy (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).
Specifically, the sexual diary allows participants to track sexual encounters, sexual
behaviors that occurred in each encounter, and rating characteristics of partners. The app
provides a calendar displaying all days in which PrEP medication was taken, and all days in
which sexual activity occurred, allowing participants to see coverage of sexual encounters
with PrEP. Based on pharmacokinetic and pharmacodynamic data from prior PrEP trials, the app
will also indicate the estimated level of protection achieved from PrEP (e.g. low, medium,
high), and also provide personalized messages on the additional numbers of doses needed to
maximize protection.

In the next stage of app development and assessment, the researchers will conduct the DOT
Diary Longitudinal Pilot to assess the impact of the app on PrEP adherence as measured by
pharmacokinetic measures of PrEP use (tenofovir diphosphate [TFV-DP] and emtricitabine
triphosphate [FTC-TP] levels in dried blood spots [DBS]). The researchers will also assess
the concordance of TFV-DP and FTC-TP in DBS with adherence measured by DOT Diary, and the
acceptability and ease of use of the app over a longer (24-week) period. This pilot study
will allow evaluation and further refinement of the app in preparation for testing in a
larger efficacy trial 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.

Inclusion Criteria:

- Self-identifies as a man

- Age 18-35 at enrollment

- Reports having insertive or receptive anal sex with a man or trans woman in the past
12 months and one or more of the following criteria in the last 12 months:

- Any condomless anal sex outside of a mutually monogamous relationship with an
HIV-negative partner

- Two or more anal sex partners

- Self-reported sexually transmitted infection (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

- Willing to initiate 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 app

- Meets local locator requirements

- Lives, works or plays in Atlanta Metropolitan Area, San Francisco, Alameda, Marin,
Contra Costa, Santa Clara, or San Mateo Counties

Exclusion Criteria:

- PrEP use within the past 4 months (PrEP naive participants will be prioritized)

- 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

- Unable to commit to study participation for 24 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.