NCT05592613CompletedPhase 3
Next Generation Ingestible Sensors for Medication Adherence Measurement
ID Cap System: Next Generation Ingestible Sensors for Medication Adherence Measurement
Source: ClinicalTrials.gov · Last updated 25 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 12 Oct 2022
- Start date
- 6 Feb 2023
- Primary completion date
- 25 Jul 2024
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- HIV
- NCT number
- NCT05592613
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 15
- From 6 Feb 2023 to the primary completion date, 25 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fenway Health Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.