Development of a Silica Microparticle Taggant System to Measure ART Adherence (TruTag)

April 23, 2026 updated by: Peter R Chai MD, Brigham and Women's Hospital

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 or older
  2. Living with HIV
  3. Currently prescribed and taking Biktarvy as ART for at least 3 months
  4. Undetectable viral load in prior 6 months
  5. Owns iPhone model 11 or higher (non-SE only)

Exclusion Criteria:

  1. Not English-speaking
  2. Unwilling to interact with the TruTag app

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TruTag System
Participants will operate the TruTag system daily to record their adherence to TruTag-tagged Biktarvy for 90 days.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of TruTag to Measure Antiretroviral (ART) Adherence
Time Frame: 30, 60, 90 days
Successful operation of the TruTag system will be measured over the 90-day study period. Total ingestions recorded by the TruTag system will be compared against total expected ingestions.
30, 60, 90 days
Acceptability of TruTag, via System Usability Scale
Time Frame: 90 days
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.
90 days
Acceptability of TruTag, via Qualitative Interviews
Time Frame: 90 days
Acceptability will be evaluated via qualitative interviews exploring participants' lived experiences operating the TruTag system and suggested improvements.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of TruTag-Measured Adherence with Dried Blood Spot Concentrations
Time Frame: 90 days
Preliminary accuracy of the TruTag system will be measured by correlating TruTag-detected ART adherence with tenofovir alafenamide concentrations in dried blood spots (DBS) collected at the 90-day visit.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Gilead Sciences
Trutag Technologies

Investigators

  • Principal Investigator: Peter R Chai, MD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024p001248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data available upon written communication with PI or study sponsor.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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