Next Generation Ingestible Sensors for Medication Adherence Measurement

NCT05592613 | Completed Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: 2022P002497
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Digital Pill System; Pre-Exposure Prophylaxis; Antiretroviral Therapy; Adherence

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

PrEP Participants

EXPERIMENTAL

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; Drug: Truvada for pre-exposure prophylaxis (PrEP)

ART Participants

EXPERIMENTAL

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; Drug: Biktarvy for antiretroviral therapy (ART)

Interventions

Next-generation Reader and ID-Cap System DEVICE

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.

Also known as: Digital pill system

ART Participants; PrEP Participants

Truvada for pre-exposure prophylaxis (PrEP) DRUG

Participants will ingest one Truvada digital pill as PrEP per day, for 30 days total.

PrEP Participants

Biktarvy for antiretroviral therapy (ART) DRUG

Participants will ingest one Biktarvy digital pill as ART per day, for 30 days total.

ART Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• The Fenway Institute: collaborator

Study Sites (1)

Fenway Health

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

HIV Infections; Medication Adherence; Treatment Adherence and Compliance

Interventions

Drug Delivery Systems; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Pre-Exposure Prophylaxis; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Peter Chai, MD, MMS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Physician

Model Details: 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).

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 24, 2022
• Study Start: February 6, 2023
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)