HivTruTagNCT06465862
Development of a Silica Microparticle Taggant System to Measure ART Adherence
A study testing TruTag System and Biktarvy Pill in people with Hiv and Medication Adherence, run by Brigham and Women's Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Medication Adherence, Compliance, Medication
- What is being tested?
- TruTag System and Biktarvy Pill
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Not English-speaking
- Unwilling to interact with the TruTag app
About this study
Official title: TruTag: Development of a Silica Microparticle Taggant System to Measure Antiretroviral Pharmacotherapy Adherence
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).
Read the 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.
- Conditions
- Hiv, Medication Adherence, Compliance, Medication
- Being tested
- TruTag System, Biktarvy Pill
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruTag SystemDevice
TruTag technology system, consisting of microparticle-tagged Biktarvy and companion smartphone app.
Biktarvy PillDrug
Biktarvy prescribed with TruTag system and tagged with TruTag microparticles.
| Study group | Role | What they receive |
|---|---|---|
| TruTag System | Experimental | Participants will operate the TruTag system daily to record their adherence to TruTag-tagged Biktarvy for 90 days. Receives: Device: TruTag System; Drug: Biktarvy Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 90 days
Secondary outcomes (1)
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start15 Sep 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion15 Apr 2025 (estimated)
Why it stopped: Study withdrawn prior to enrollment due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pilot demonstration
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Trutag Technologies, Gilead Sciences
- Responsible party
- Principal investigator, Peter R Chai MD, Brigham and Women's Hospital
- Investigators
- Peter R Chai, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465862
- Sponsor's protocol ID
- 2024p001248
- Acronym
- TruTag
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available upon written communication with PI or study sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TruTag: Development of a Silica Microparticle Taggant System to Measure Antiretroviral Pharmacotherapy Adherence
- ClinicalTrials.gov ID
- NCT06465862
- Acronym / sponsor ID
- TruTag / 2024p001248
- Conditions
- Hiv, Medication Adherence, Compliance, Medication
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn prior to enrollment due to lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Trutag Technologies, Gilead Sciences
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pilot demonstration
| Arm | Type | Receives |
|---|---|---|
| TruTag System | Experimental | Device: TruTag System, Drug: Biktarvy PillParticipants will operate the TruTag system daily to record their adherence to TruTag-tagged Biktarvy for 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- Not English-speaking
- Unwilling to interact with the TruTag app
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruTag SystemTruTag technology system, consisting of microparticle-tagged Biktarvy and companion smartphone app. | Device | TruTag System |
| Biktarvy PillBiktarvy prescribed with TruTag system and tagged with TruTag microparticles. | Drug | TruTag System |
Primary outcome
Feasibility of TruTag to Measure Antiretroviral (ART) Adherence
Time frame: 30, 60, 90 days
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.
Acceptability of TruTag, via System Usability Scale
Time frame: 90 days
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.
Acceptability of TruTag, via Qualitative Interviews
Time frame: 90 days
Acceptability will be evaluated via qualitative interviews exploring participants' lived experiences operating the TruTag system and suggested improvements.
1 secondary outcome
Correlation of TruTag-Measured Adherence with Dried Blood Spot Concentrations
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No. Data available upon written communication with PI or study sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter R Chai, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TruTag System and Biktarvy Pill in people with Hiv and Medication Adherence, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of TruTag to Measure Antiretroviral (ART) Adherence (time frame: 30, 60, 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.