Clinical trial

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

Name
2024p001248
Description
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).
Trial arms
Trial start
2024-07-01
Estimated PCD
2024-12-30
Trial end
2025-04-15
Status
Not yet recruiting
Treatment
TruTag System
TruTag technology system, consisting of microparticle-tagged Biktarvy and companion smartphone app.
Arms:
TruTag System
Biktarvy Pill
Biktarvy prescribed with TruTag system and tagged with TruTag microparticles.
Arms:
TruTag System
Size
15
Primary endpoint
Feasibility of TruTag to Measure Antiretroviral (ART) Adherence
30, 60, 90 days
Acceptability of TruTag, via System Usability Scale
90 days
Acceptability of TruTag, via Qualitative Interviews
90 days
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm pilot demonstration', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}
Updated at
2024-06-19

1 organization

1 product

4 indications

Product
Biktarvy
Indication
HIV
Indication
Adherence
Indication
Compliance
Indication
Medication