Phase 4
Completed N=20
DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
Adherence, Medication · Risk Behavior · Pre-Exposure Prophylaxis · HIV
Source: ClinicalTrials.gov NCT03387462 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: DOT Diary Mobile App Acceptability — 79.8 Score on scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DOT Diary Mobile App Acceptability |
79.8 | — |
| PRIMARY DOT Diary Mobile App Ease of Use |
4 | — |
| PRIMARY Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP |
93 | — |
| SECONDARY Assessment of Situations and Reasons for Sub-optimal Use of the App |
8; 6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03387462). 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. Informational only — not medical advice.