Ignite Creation Date:
2024-07-17 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465862
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-05
Brief Title:
Development of a Silica Microparticle Taggant System to Measure ART Adherence
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
TruTag Development of a Silica Microparticle Taggant System to Measure Antiretroviral Pharmacotherapy Adherence
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
TruTag
Brief Summary:
Developing technologies to help measure and provide tools to support medication-taking behaviors medication adherence is an important step to ending the human immunodeficiency virus HIV epidemic TruTag Technologies has pioneered the use of a microparticle system that can be incorporated into the coating of medications may help users both identify the medication they are taking and record adherence events By using a standard smartphone camera shining light on TruTag-coated medications automatically identifies them to an onboard smartphone app which then indirectly records the adherence event This study evaluates the real-world usability and feasibility of operating this system among people living with HIV PLWH
Detailed Description:
This is an open-label pilot trial of N15 PLWH who are prescribed BictegravirEmtricitabineTenofovir Alafenamide Biktarvy for antiretroviral therapy ART Participants will receive special TruTag-tagged Biktarvy and will be asked to scan their TruTag Biktarvy prior to ingesting it daily over 90 days A companion smartphone app will record scans as an indirect measure of adherence Included in the app will be a reminder system to nudge individuals to take their Biktarvy and a two-way text portal that allows participants to communicate securely with the study team Participants will be screened and enrolled and will then attend three monthly study visits where the study team will assess adherence dispense TruTag Biktarvy and understand how the TruTag system is operated in the real world At the final 90-day study visit the study team will conduct a qualitative interview to explore acceptability and future design iterations of the TruTag system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None