Clinical trial NCT06465862: Development of a Silica Microparticle Taggant System to Measure ART Adherence
Official title: TruTag: Development of a Silica Microparticle Taggant System to Measure Antiretroviral Pharmacotherapy Adherence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Medication Adherence
Compliance, Medication
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Trutag Technologies
name: Gilead Sciences
First posted: 2024-06-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot demonstration
Primary purpose: OTHER

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 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.

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

Primary outcomes:
measure: Feasibility of TruTag to Measure Antiretroviral (ART) Adherence
timeFrame: 30, 60, 90 days
measure: Acceptability of TruTag, via System Usability Scale
timeFrame: 90 days
measure: Acceptability of TruTag, via Qualitative Interviews
timeFrame: 90 days
Secondary outcomes:
measure: Correlation of TruTag-Measured Adherence with Dried Blood Spot Concentrations
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Peter R Chai, MD
role: PRINCIPAL_INVESTIGATOR
References: