Clinical trial NCT05592613: Next Generation Ingestible Sensors for Medication Adherence Measurement
Official title: ID Cap System: Next Generation Ingestible Sensors for Medication Adherence Measurement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infection
Adherence, Medication
Adherence, Treatment
Pre-Exposure Prophylaxis
Antiretroviral Therapy
Keywords: Digital Pill System
Pre-Exposure Prophylaxis
Antiretroviral Therapy
Adherence
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: The Fenway Institute
First posted: 2022-10-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For 30 days, the next-generation Reader and ID-Cap System will be used in an open-label, observational trial with N=30 participants (N=15 HIV-negative individuals on PrEP and N=15 PLWH on ART).
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Next-Generation ID-Cap System to Measure PrEP/ART Adherence
timeFrame: Month 1 study visit
measure: Correlation of PrEP/ART Adherence with DBS Concentrations and Pill Counts
timeFrame: Month 1 study visit
measure: Acceptability of Next-Generation ID-Cap System, via System Usability Scale
timeFrame: Month 1 study visit
measure: Acceptability of Next-Generation ID-Cap System, via Qualitative Interviews
timeFrame: Month 1 study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Health
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Peter Chai, MD, MMS
role: PRINCIPAL_INVESTIGATOR
References: