Phase 4
N=100
DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men
Adherence, Medication · Risk Behavior · Pre-Exposure Prophylaxis · HIV Prevention
Bottom Line
View on ClinicalTrials.gov: NCT03771638 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Effect of DOT Diary App on PrEP Adherence — 39; 19 Participants — p=0.94
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Emtricitabine / Tenofovir Disoproxil Oral Tablet (Drug); DOT Diary mobile app (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Public Health Foundation Enterprises, Inc.
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of DOT Diary App on PrEP Adherence |
39; 19 | 0.94 |
| PRIMARY Concordance of TFV-DP and FTC-TP in DBS With Adherence Measured by DOT Diary App |
34; 29; 13; 135 | — |
| PRIMARY DOT Diary Mobile App Acceptability |
77.9 | — |
| PRIMARY DOT Diary Mobile App Ease of Use |
4.3 | — |
| SECONDARY PrEP Coverage of Sexual Acts (Prevention-effectiveness Adherence) as Measured by DOT Diary |
93 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03771638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.