DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
Condition: Adherence, Medication; Risk Behavior; Pre-Exposure Prophylaxis; HIV Prevention
Intervention: Emtricitabine / Tenofovir Disoproxil Oral Tablet; DOT Diary mobile app
Intervention description: Open label daily emtricitabine/tenofovir disoproxil oral tablet; DOT Diary mobile application for tracking medication adherence and sexual activities.
Intervention MeSH terms: Tenofovir; Emtricitabine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adherence; PrEP; HIV Prevention; Truvada; HIV Risk Reduction; Mobile App

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.
    

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.