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NCT05592613 · ClinicalTrials.gov registry record · Phase 3
Next Generation Ingestible Sensors for Medication Adherence Measurement
A Phase 3 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
NCT05592613: Completed Phase 3 study, sponsored by Brigham and Women's Hospital.
NCT05592613 is a Phase 3 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 15 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05592613, a Phase 3 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study will investigate the use of a next-generation Reader as part of a digital pill system (DPS; ID-Cap System) to measure adherence to both antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) in people living with HIV (PLWH) and HIV-negative individuals, respectively. During the first (non-human subjects) component of this study, we developed a wrist-borne Reader according to design specifications and preferences shared by DPS users from our previous studies. Early bench testing by etectRx (manufacturer of the ID-Cap System) demonstrated that the wrist-borne version of the Reader acquires signal from the digital pill. This study will therefore evaluate the usability of and user response to a wrist-borne Reader component of the DPS among PLWH on ART and HIV-negative individuals on PrEP.
Primary Outcome
Participants' engagement with the digital pill system (DPS) -- the next-generation ID-Cap System -- will be measured over the 30-day study period. The percentages for the total expected ingestions recorded by the DPS each month will be compared to adherence detected by the DPS.
Interventions
- DEVICE Next-generation Reader and ID-Cap System
- DRUG Truvada for pre-exposure prophylaxis (PrEP)
- DRUG Biktarvy for antiretroviral therapy (ART)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-02-06 |
| Est. Completion | 2024-07-25 |
| Phase | Phase 3 |
What the finished NCT05592613 record still lists
NCT05592613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Next-generation Reader and ID-Cap System is the first listed.
NCT05592613 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05592613 about?
NCT05592613 is a clinical study titled "Next Generation Ingestible Sensors for Medication Adherence Measurement". This study will investigate the use of a next-generation Reader as part of a digital pill system (DPS; ID-Cap System) to measure adherence to both antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) in people living with HIV (PLWH) and HIV-negative individuals, respectively. During the ...
What is the current status of trial NCT05592613?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2023-02-06. Estimated completion is 2024-07-25.
What interventions are being tested in trial NCT05592613?
The interventions under investigation include: Next-generation Reader and ID-Cap System (DEVICE), Truvada for pre-exposure prophylaxis (PrEP) (DRUG), Biktarvy for antiretroviral therapy (ART) (DRUG).
Who is sponsoring clinical trial NCT05592613?
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 NCT05592613's enrollment target sits among peer trials
15 1977th of 2000 higher than 18 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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