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NCT03387462 · ClinicalTrials.gov registry record · Phase 4
DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
A Phase 4 study of HIV Prevention and Adherence, Medication, sponsored by Public Health Foundation Enterprises.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT03387462: Completed Phase 4 study of HIV Prevention and Adherence, Medication, sponsored by Public Health Foundation Enterprises.
NCT03387462 is a Phase 4 study of HIV Prevention and Adherence, Medication that has completed, run by Public Health Foundation Enterprises. The registered enrollment target is 20 participants, below the 381-participant average among 32 other HIV Prevention trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03387462, a Phase 4 study of HIV Prevention and Adherence, Medication, has completed, sponsored by Public Health Foundation Enterprises.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
System Usability Scale (SUS) is a 10 item questionnaire with 5 response options: strongly disagree to strongly agree. These are scored 0-4. The scores are then summed up (making sure all positive responses -- increased usability -- are given the higher scores). The final score is multiplied by 2.5 Possible scores are from 0-100, with maximal usability achieving the higher score. Although the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ra
Conditions Studied
Interventions
- DRUG Emtricitabine / Tenofovir Disoproxil Oral Tablet
- OTHER DOT Diary mobile app
Study Locations (2)
California
- Bridge HIV, San Francisco Department of Public Health - San Francisco
Georgia
- Emory University, School of Public Health - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-02-28 |
| Est. Completion | 2018-08-30 |
| Phase | Phase 4 |
What the finished NCT03387462 record still lists
NCT03387462 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 381-participant average among 32 other HIV Prevention trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with HIV Prevention appearing as the primary indexed condition, and to 2 interventions - of which Emtricitabine / Tenofovir Disoproxil Oral Tablet is the first listed.
NCT03387462 reports a single indexed study location in California, Georgia.
Frequently Asked Questions
What is clinical trial NCT03387462 about?
NCT03387462 is a clinical study titled "DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence". 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 wa...
What is the current status of trial NCT03387462?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2018-02-28. Estimated completion is 2018-08-30.
What conditions does trial NCT03387462 study?
This clinical trial studies the following conditions: HIV Prevention, Adherence, Medication, Pre-exposure Prophylaxis, Risk Behavior.
What interventions are being tested in trial NCT03387462?
The interventions under investigation include: Emtricitabine / Tenofovir Disoproxil Oral Tablet (DRUG), DOT Diary mobile app (OTHER).
Who is sponsoring clinical trial NCT03387462?
This trial is sponsored by Public Health Foundation Enterprises, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03387462 being conducted?
This trial has 2 study locations across California, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03387462's enrollment target sits among peer trials
20 32nd of 32 higher than 1 of 32 other HIV Prevention trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Prevention trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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