Next Generation Ingestible Sensors for Medication Adherence Measurement
Completed · Phase 3
Conditions studied: HIV Infection, Adherence, Medication, Adherence, Treatment, Pre-Exposure Prophylaxis, Antiretroviral Therapy
In brief
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.
Key facts
- Study ID
- NCT05592613
- Run by
- Brigham and Women's Hospital
- People needed
- 15
- Starts
- 2023-02-06
- Expected to finish
- 2024-07-25
- Last updated by the study team
- 2024-09-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- PrEP Participants:
- Age 18 or older
- HIV negative
- Prescribed and currently taking Truvada for PrEP for at least 30 days
- Qualifying labs for PrEP (Cr clearance in past 6 months, HBV vaccination, liver function tests)
- Owns a smartphone with Android or iOS
- ART Participants:
- Age 18 or older
- Diagnosed with HIV
- Prescribed and taking Biktarvy for at least 6 months
- Undetectable viral load during prior 6 months
- Owns a smartphone with Android or iOS
You may not qualify if…
- PrEP Participants:
- Does not speak English
- History of Crohn's disease or ulcerative colitis
- History of gastric bypass or bowel stricture
- History of GI malignancy or radiation to abdomen
- Allergy to gelatin, silver, or zinc
- Implanted cardiac device, nerve stimulator, or drug infusion pump
- Not willing to operate DPS
- ART Participants:
- Does not speak English
- History of Crohn's disease or ulcerative colitis
- History of gastric bypass or bowel stricture
- History of GI malignancy or radiation to abdomen
- Allergy to gelatin, silver, or zinc
- Implanted cardiac device, nerve stimulator, or drug infusion pump
- Not willing to operate DPS
Where it is running
- Fenway Health — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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