Not provided
Not provided
Not provided
Not provided
Not provided
Study withdrawn prior to enrollment due to lack of funding.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Trutag Technologies | UNKNOWN |
| Gilead Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TruTag System | Experimental | Participants will operate the TruTag system daily to record their adherence to TruTag-tagged Biktarvy for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TruTag System | Device | TruTag technology system, consisting of microparticle-tagged Biktarvy and companion smartphone app. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter R Chai, MD | Brigham and Women's Hospital | Principal Investigator |
Not provided
Data available upon written communication with PI or study sponsor.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2024 | Jun 13, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
Not provided
Not provided
Not provided
Single arm pilot demonstration
Not provided
Not provided
Not provided
Not provided
| Biktarvy Pill | Drug | Biktarvy prescribed with TruTag system and tagged with TruTag microparticles. |
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |