TruTag: Development of a Silica Microparticle Taggant System to Measure Antiretroviral Pharmacotherapy Adherence
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 15
- 主要终点
- Acceptability of TruTag, via System Usability Scale
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Not English-speaking
- •Unwilling to interact with the TruTag app
研究组 & 干预措施
TruTag System
Participants will operate the TruTag system daily to record their adherence to TruTag-tagged Biktarvy for 90 days.
干预措施: TruTag System (Device)
TruTag System
Participants will operate the TruTag system daily to record their adherence to TruTag-tagged Biktarvy for 90 days.
干预措施: Biktarvy Pill (Drug)
结局指标
主要结局
Acceptability of TruTag, via System Usability Scale
时间窗: 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.
Feasibility of TruTag to Measure Antiretroviral (ART) Adherence
时间窗: 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 Qualitative Interviews
时间窗: 90 days
Acceptability will be evaluated via qualitative interviews exploring participants' lived experiences operating the TruTag system and suggested improvements.
次要结局
- Correlation of TruTag-Measured Adherence with Dried Blood Spot Concentrations(90 days)
研究者
Peter R Chai MD
Associate Professor of Emergency Medicine
Brigham and Women's Hospital