Next Generation Ingestible Sensors for Medication Adherence Measurement (NextGen)

ID Cap System: 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 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.

Study Overview

• Status: Completed
• Conditions: HIV Infection; Adherence, Medication; Antiretroviral Therapy; Adherence, Treatment; Pre-Exposure Prophylaxis
• Intervention / Treatment: Device: Next-generation Reader and ID-Cap System; Drug: Truvada for pre-exposure prophylaxis (PrEP); Drug: Biktarvy for antiretroviral therapy (ART)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Fenway Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: Digital pill system; Drug: Truvada for pre-exposure prophylaxis (PrEP); Participants will ingest one Truvada digital pill as PrEP per day, for 30 days total.
Experimental: 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.	Device: 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.; Other Names: Digital pill system; Drug: Biktarvy for antiretroviral therapy (ART); Participants will ingest one Biktarvy digital pill as ART per day, for 30 days total.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Next-Generation ID-Cap System to Measure PrEP/ART Adherence	Participants' engagement with the digital pill system (DPS) -- the next-generation ID-Cap System -- will be measured over the 30-day study period. The percentages for the total expected ingestions recorded by the DPS each month will be compared to adherence detected by the DPS.	Month 1 study visit
Correlation of PrEP/ART Adherence with DBS Concentrations and Pill Counts	Correlation of PrEP/ART adherence patterns, as detected by the next-generation ID-Cap System, with tenofovir diphosphate concentrations in dried blood spots (DBS) and pill counts of unused digital pills following the 30-day study period.	Month 1 study visit
Acceptability of Next-Generation ID-Cap System, via System Usability Scale	Acceptability will be measured via the System Usability Scale (SUS). The SUS is a 10-item measure of perceived usability of a technological system, scored on a 5-point Likert scale (1: strongly disagree, 5: strongly agree), with higher scores indicating greater perceived usability. A mean score of >68 will be used to indicate that the technology is acceptable.	Month 1 study visit
Acceptability of Next-Generation ID-Cap System, via Qualitative Interviews	Acceptability will be evaluated via qualitative interviews exploring participants' lived experiences operating the next-generation ID-Cap system and suggestions for improving the design of the technology.	Month 1 study visit

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: The Fenway Institute
• Investigators: Principal Investigator: Peter Chai, MD, MMS, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): July 25, 2024
• Study Completion (Actual): July 25, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Adherence; Antiretroviral Therapy; Pre-Exposure Prophylaxis; Digital Pill System
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Anti-Retroviral Agents
• Other Study ID Numbers: 2022P002497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No