Next Generation Ingestible Sensors for Medication Adherence Measurement
NCT ID: NCT05592613
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
15 participants
INTERVENTIONAL
2023-02-06
2024-07-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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PrEP Participants
Participants will ingest one Truvada digital pill as PrEP per day, for 30 days total, while using the next-generation Reader and ID-Cap System.
Next-generation Reader and ID-Cap System
The digital pill system (DPS) is comprised of an ingestible radiofrequency emitter, integrated into a standard gelatin capsule, which then over-encapsulates the study medication (PrEP or ART). On ingestion, the radiofrequency emitter is activated by chloride ions in the stomach, projecting a signal approximately three feet off the body. This radio signal is acquired by a wearable device (Reader) which stores and forwards data to a smartphone, enabling on-demand access to adherence data. The next-generation Reader is a wrist-borne device.
Truvada for pre-exposure prophylaxis (PrEP)
Participants will ingest one Truvada digital pill as PrEP per day, for 30 days total.
ART Participants
Participants will ingest one Biktarvy digital pill as ART per day, for 30 days total, while using the next-generation Reader and ID-Cap System.
Next-generation Reader and ID-Cap System
The digital pill system (DPS) is comprised of an ingestible radiofrequency emitter, integrated into a standard gelatin capsule, which then over-encapsulates the study medication (PrEP or ART). On ingestion, the radiofrequency emitter is activated by chloride ions in the stomach, projecting a signal approximately three feet off the body. This radio signal is acquired by a wearable device (Reader) which stores and forwards data to a smartphone, enabling on-demand access to adherence data. The next-generation Reader is a wrist-borne device.
Biktarvy for antiretroviral therapy (ART)
Participants will ingest one Biktarvy digital pill as ART per day, for 30 days total.
Interventions
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Next-generation Reader and ID-Cap System
The digital pill system (DPS) is comprised of an ingestible radiofrequency emitter, integrated into a standard gelatin capsule, which then over-encapsulates the study medication (PrEP or ART). On ingestion, the radiofrequency emitter is activated by chloride ions in the stomach, projecting a signal approximately three feet off the body. This radio signal is acquired by a wearable device (Reader) which stores and forwards data to a smartphone, enabling on-demand access to adherence data. The next-generation Reader is a wrist-borne device.
Truvada for pre-exposure prophylaxis (PrEP)
Participants will ingest one Truvada digital pill as PrEP per day, for 30 days total.
Biktarvy for antiretroviral therapy (ART)
Participants will ingest one Biktarvy digital pill as ART per day, for 30 days total.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
2. 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
Exclusion Criteria
* 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
2. 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
18 Years
ALL
No
Sponsors
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The Fenway Institute
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Peter R Chai MD
Emergency Medicine Physician
Principal Investigators
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Peter Chai, MD, MMS
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Fenway Health
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2022P002497
Identifier Type: -
Identifier Source: org_study_id
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