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NCT03771638 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Public Health Foundation Enterprises.

Completed
Registry status
Phase 4
Development phase
100
Enrollment target

NCT03771638: Completed Phase 4 study, sponsored by Public Health Foundation Enterprises.

NCT03771638 is a Phase 4 study that has completed, run by Public Health Foundation Enterprises. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03771638, a Phase 4 study, has completed, sponsored by Public Health Foundation Enterprises.

COMPLETED
Registry status
Phase 4
Development phase
100 participants
Enrollment target

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 assess the impact of the app on adherence to HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.

Primary Outcome

Measurement of PrEP Adherence as measured by TFV-DP level \>=700 fmol/punch in DBS among young MSM initiating PrEP

Interventions

  • DRUG Emtricitabine / Tenofovir Disoproxil Oral Tablet
  • OTHER DOT Diary mobile app

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2019-02-01
Est. Completion 2020-04-21
Phase Phase 4

What the finished NCT03771638 record still lists

NCT03771638 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 2 interventions - of which Emtricitabine / Tenofovir Disoproxil Oral Tablet is the first listed.

NCT03771638 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03771638 about?

NCT03771638 is a clinical study titled "DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men". 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 NCT03771638?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2019-02-01. Estimated completion is 2020-04-21.

What interventions are being tested in trial NCT03771638?

The interventions under investigation include: Emtricitabine / Tenofovir Disoproxil Oral Tablet (DRUG), DOT Diary mobile app (OTHER).

Who is sponsoring clinical trial NCT03771638?

This trial is sponsored by Public Health Foundation Enterprises, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03771638's enrollment target sits among peer trials

100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03771638, the US trial registry maintained by the National Library of Medicine. NCT03771638 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.