Next Generation Ingestible Sensors for Medication Adherence Measurement (NextGen)

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: Pre-Exposure Prophylaxis; Adherence, Treatment; Adherence, Medication; Antiretroviral Therapy; HIV Infection

Treatments: Drug: Truvada for pre-exposure prophylaxis (PrEP); Drug: Biktarvy for antiretroviral therapy (ART); Device: Next-generation Reader and ID-Cap System

Study type: Interventional

Funder types: Other

Identifiers

NCT05592613

2022P002497

Details and patient eligibility

About

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.

Full description

This is a single-arm, observational trial (N=30), which will enroll N=15 people living with HIV (PLWH) using Biktarvy as antiretroviral therapy (ART) and N=15 HIV-negative individuals using Truvada as pre-exposure prophylaxis (PrEP). Potential participants will be approached and pre-screened. Those who meet pre-screening criteria will attend a Screening Visit (Visit 1), where the informed consent process will be conducted and eligibility will be confirmed. Eligible participants will attend a total of 3 study visits: the Screening Visit (Visit 1), Enrollment Visit (Visit 2), and Month 1 Visit (Visit 3). Participants will take one digital pill per day (Biktarvy as ART or Truvada as PrEP) for 30 days total, while using the next-generation Reader with a digital pill system, the ID-Cap System. Timeline followback discussions will be conducted at the Month 1 Visit to understand the context of any nonadherence detected by the digital pill system. Qualitative user experience exit interviews, quantitative assessments, dried blood spots (DBS), and pill counts of unused medication will also be conducted at the Month 1 Visit.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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

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

1. 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

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

PrEP Participants

Experimental group

Description:

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.

Treatment:

Device: Next-generation Reader and ID-Cap System

Drug: Truvada for pre-exposure prophylaxis (PrEP)

ART Participants

Experimental group

Description:

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.

Treatment:

Device: Next-generation Reader and ID-Cap System

Drug: Biktarvy for antiretroviral therapy (ART)