Development of a Silica Microparticle Taggant System to Measure ART Adherence

NCT06465862 | Withdrawn

• 1 other identifier: 2024p001248
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hiv; Medication Adherence; Compliance, Medication

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Correlation of TruTag-Measured Adherence with Dried Blood Spot Concentrations

  90 days

Study Arms (1)

TruTag System

EXPERIMENTAL

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

Device: TruTag System; Drug: Biktarvy Pill

Interventions

TruTag System DEVICE

TruTag technology system, consisting of microparticle-tagged Biktarvy and companion smartphone app.

TruTag System

Biktarvy Pill DRUG

Biktarvy prescribed with TruTag system and tagged with TruTag microparticles.

TruTag System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not English-speaking
• Unwilling to interact with the TruTag app

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Trutag Technologies: collaborator
• Gilead Sciences: collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Medication Adherence

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Peter R Chai, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine

Model Details: Single arm pilot demonstration

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 20, 2024
• Study Start: September 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: April 15, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share