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NCT03512418 · ClinicalTrials.gov registry record · Phase 3
Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
A Phase 3 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT03512418: Completed Phase 3 study, sponsored by Brigham and Women's Hospital.
NCT03512418 is a Phase 3 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03512418, a Phase 3 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill. The PrEPSteps intervention will be developed and refined through a series of focus groups. Participants will be screened at the Screening Visit, and, if eligible, will then begin using the digital pill system at Study Visit 1 for 2 weeks. At Study Visit 2, participants will undergo randomization to using either PrEPSteps + the digital pill, or the digital pill alone to measure PrEP adherence, for 90 days. Participants will then complete 3 monthly study visits (Study Visits 3-5) where the investigators will assess digital pill adherence, conduct manual pill counts, obtain dried blood spots to confirm adherence, provide substance use disorder counseling, and obtain urine drug screens. At Study Visit 5, the investigators will conduct a semi-structured qualitative interview with participants in the PrEPsteps arm, which will be grounded in the Technology Acceptance Model, in order to understand the user response to PrEPSteps and the digital pill. All participants will complete the final follow-up assessment 3 months after Study Visit 5 (Study Visit 6).
Primary Outcome
Number of participants who were able to complete the trial and record adherence events using the digital pill system in the intervention arm.
Interventions
- DRUG Truvada
- BEHAVIORAL PrEPsteps
- DEVICE Digital pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-06-20 |
| Est. Completion | 2024-04-10 |
| Phase | Phase 3 |
What the finished NCT03512418 record still lists
NCT03512418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Truvada is the first listed.
NCT03512418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03512418 about?
NCT03512418 is a clinical study titled "Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)". This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill. The PrEPSteps intervention will be developed and refined through a series of focus groups. Participants will ...
What is the current status of trial NCT03512418?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2019-06-20. Estimated completion is 2024-04-10.
What interventions are being tested in trial NCT03512418?
The interventions under investigation include: Truvada (DRUG), PrEPsteps (BEHAVIORAL), Digital pill (DEVICE).
Who is sponsoring clinical trial NCT03512418?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03512418's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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