Development of a Silica Microparticle Taggant System to Measure ART Adherence

Hiv Clinical Trial

— TruTag  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465862
• Other study ID #: 2024p001248
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: June 2024
• Source: Brigham and Women's Hospital
• Contact: Peter R Chai, MD
• Phone: 617-927-6266
• Email: pchai[@]fenwayhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: April 15, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Compliance, Medication
• Hiv
• Medication Adherence

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Gilead Sciences, Trutag Technologies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of TruTag to Measure Antiretroviral (ART) Adherence	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
Primary	Acceptability of TruTag, via System Usability Scale	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
Primary	Acceptability of TruTag, via Qualitative Interviews	Acceptability will be evaluated via qualitative interviews exploring participants' lived experiences operating the TruTag system and suggested improvements.	90 days
Secondary	Correlation of TruTag-Measured Adherence with Dried Blood Spot Concentrations	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