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Next Generation Ingestible Sensors for Medication Adherence Measurement (NextGen)

Primary Purpose

HIV Infection, Adherence, Medication, Adherence, Treatment

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Next-generation Reader and ID-Cap System
Truvada for pre-exposure prophylaxis (PrEP)
Biktarvy for antiretroviral therapy (ART)
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV Infection focused on measuring Digital Pill System, Pre-Exposure Prophylaxis, Antiretroviral Therapy, Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fenway HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PrEP Participants

ART Participants

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2022
Last Updated
March 15, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
The Fenway Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05592613
Brief Title
Next Generation Ingestible Sensors for Medication Adherence Measurement
Acronym
NextGen
Official Title
ID Cap System: Next Generation Ingestible Sensors for Medication Adherence Measurement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
The Fenway Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Adherence, Medication, Adherence, Treatment, Pre-Exposure Prophylaxis, Antiretroviral Therapy
Keywords
Digital Pill System, Pre-Exposure Prophylaxis, Antiretroviral Therapy, Adherence

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PrEP Participants
Arm Type
Experimental
Arm 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.
Arm Title
ART Participants
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Next-generation Reader and ID-Cap System
Other Intervention Name(s)
Digital pill system
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Truvada for pre-exposure prophylaxis (PrEP)
Intervention Description
Participants will ingest one Truvada digital pill as PrEP per day, for 30 days total.
Intervention Type
Drug
Intervention Name(s)
Biktarvy for antiretroviral therapy (ART)
Intervention Description
Participants will ingest one Biktarvy digital pill as ART per day, for 30 days total.
Primary Outcome Measure Information:
Title
Feasibility of Next-Generation ID-Cap System to Measure PrEP/ART Adherence
Description
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.
Time Frame
Month 1 study visit
Title
Correlation of PrEP/ART Adherence with DBS Concentrations and Pill Counts
Description
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.
Time Frame
Month 1 study visit
Title
Acceptability of Next-Generation ID-Cap System, via System Usability Scale
Description
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.
Time Frame
Month 1 study visit
Title
Acceptability of Next-Generation ID-Cap System, via Qualitative Interviews
Description
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.
Time Frame
Month 1 study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Not willing to operate DPS
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter R Chai, MD, MMS
Phone
857-313-6855
Email
pchai@fenwayhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Yassir Mohamed, MD, MPH
Phone
857-313-6587
Email
ymohamed@fenwayhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Chai, MD, MMS
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fenway Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter R Chai, MD, MMS
Phone
617-732-5640
Email
pchai@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Yassir Mohamed, MD, MPH
Phone
857-313-6587
Email
ymohamed@fenwayhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Next Generation Ingestible Sensors for Medication Adherence Measurement

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