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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 is a Phase 3 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 15 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05592613
The ClinicalTrials.gov registry entry for NCT05592613 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 15 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 Next-generation Reader and ID-Cap System is the first listed.
NCT05592613 reports 0 study locations.
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.
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