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

Mass General Brigham

Status: Not yet enrolling

Conditions: Medication Adherence; Compliance, Medication; Hiv

Treatments: Drug: Biktarvy Pill; Device: TruTag System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06465862

2024p001248

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

TruTag System

Experimental group

Description:

Participants will operate the TruTag system daily to record their adherence to TruTag-tagged Biktarvy for 90 days.

Treatment:

Device: TruTag System

Drug: Biktarvy Pill