Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05592613
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2022-10-12
Brief Title:
Next Generation Ingestible Sensors for Medication Adherence Measurement
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
ID Cap System Next Generation Ingestible Sensors for Medication Adherence Measurement
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NextGen
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 N30 which will enroll N15 people living with HIV PLWH using Biktarvy as antiretroviral therapy ART and N15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None