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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 is a Phase 3 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 30 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03512418
The ClinicalTrials.gov registry entry for NCT03512418 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Truvada is the first listed.
NCT03512418 reports 0 study locations.
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.
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