NCT06465862

Development of a Silica Microparticle Taggant System to Measure ART Adherence

TruTag: Development of a Silica Microparticle Taggant System to Measure Antiretroviral Pharmacotherapy Adherence

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 N=15 PLWH who are prescribed Bictegravir/Emtricitabine/Tenofovir 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.

Conditions

• Hiv
• Medication Adherence
• Compliance, Medication

Interventions

Type	Name	Description
DEVICE	TruTag System	TruTag technology system, consisting of microparticle-tagged Biktarvy and companion smartphone app.
DRUG	Biktarvy Pill	Biktarvy prescribed with TruTag system and tagged with TruTag microparticles.

Timeline

• Start date: 2024-09-15
• Primary completion: 2024-12-30
• Completion: 2025-04-15
• First posted: 2024-06-20
• Last updated: 2024-08-29