MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence among HIV+ Prescription Opioid Users

项目概要/摘要 电子依从性监测（EAM）技术被广泛用于支持抗逆转录病毒药物依从性。不幸的是， 像Wisepill这样的EAM假设，但不能核实，口服药物的实际摄入。相反，我的/治疗/药丸 （MyTPill）是一种直接测量摄入量的创新技术，包括含有药物的数字药丸， 明胶胶囊里的微型无线电发射器当数字药丸被摄入时，胃内容物溶解胶囊以激活 发射器。数字药丸将实时摄入数据“同步”到智能手机应用程序，以提供生动，无可争议的措施 药物摄入。然而，还没有对环境影响评估机制进行头对头的比较。识别上级 EAM将通过实现实时干预来支持ART依从性，从而改善病毒学抑制。在这 随机对照试验，我们将在服用处方阿片类药物的N = 80名HIV+男性/女性中比较MyTPill和WisePill 以及每日一次的ART方案，其含有病毒载量> 200/mL的替诺福韦和恩曲他滨。HIV+患者 处方阿片类药物难以坚持ART方案，尽管原因尚不完全清楚。考虑到高 艾滋病毒阳性个体中处方阿片类药物滥用的流行率-是艾滋病毒阴性者的三倍-和惊人的比率 次优的ART依从性（比那些没有误用的人差46%），改善ART依从性的策略， 人口迫切需要。参与者将在交叉试验中随机分配至（1）MyTPill x 3个月，然后 WisePill x 3个月;或（2）WisePill x 3个月，然后MyTPill x 3个月。通过MyTPill和WisePill测量的依从性将 与替诺福韦二磷酸盐（累积依从性）和恩曲他滨的干血斑（DBS）浓度相比， 三磷酸盐（用于最近的依从性）。参与者将根据以下要求在多个随机时间提供DBS样本： 防止预期采样但评估累积/近期ART依从性的时间表。我们还将 检查处方阿片类药物使用的哪些方面，疼痛，戒断，以及人口统计学，社会，结构和其他 环境背景（通过时间轴追踪和定量访谈测量）与ART最密切相关 坚持。此外，我们将研究这些方面如何影响MyTPill和WisePill的ART依从性措施。 主要目的：确定与Wisepill相比，MyTPill是否表现出：（1）更好地测量近期和累积ART 使用DBS作为"金标准"时的依从性;（2）通过观察和 自我报告的测量（例如，学习保持、对学习的忠诚、协议相对主观指数、定性访谈）。 次要目的：检查处方阿片类药物使用的哪些方面（例如，阿片类药物处方使用/滥用 由MyTPill，技术颠覆，疼痛，人口统计学，社会，其他结构因素）与ART最密切相关 不依从性（根据DBS），以及它们如何影响使用MyTPill和Wisepill测量ART依从性。公共卫生 意义：如果MyTPill，一种非侵入性的，独立的，几乎自动化的ART EAM，优于其他策略， 将作为后续研究测试实时ART依从性干预的平台; 2）特定因素 与ART依从性不佳相关的问题可以通过针对接受HIV阳性者的干预措施来解决。 处方阿片类药物; 3）MyTPill可以直接解决因治疗慢性疼痛而引起的阿片类药物滥用危机。

Project Summary/Abstract Electronic adherence monitoring (EAM) technologies are widely used to support antiretroviral adherence. Unfortunately, EAMs such as Wisepill assume, but cannot verify, actual ingestion of oral medication. In contrast, My/Treatment/Pill (MyTPill), an innovative technology that directly measures ingestion, comprises a digital pill containing a medication and tiny radio emitter in a gelatin capsule. When the digital pill is ingested, gastric contents dissolve the capsule to activate the emitter. The digital pill “syncs” real-time ingestion data to a smartphone application to provide vivid, indisputable measures of medication ingestion. Head-to-head comparisons of EAMs, however, have yet to be performed. Identifying the superior EAM would improve virologic suppression by enabling real-time interventions to support ART adherence. In this randomized controlled trial, we will compare MyTPill to WisePill among N=80 HIV+ men/women taking prescription opioids and once-daily ART regimens containing tenofovir and emtricitabine with a viral load >200/mL. HIV+ patients on prescription opioids have difficulty adhering to ART regimens, although the reasons are not fully known. Given the high prevalence of prescription opioid misuse among HIV+ individuals—triple that of HIV-negative persons—and striking rates of suboptimal ART adherence (46% worse than those who do not misuse), strategies to improve ART adherence in this population are critically needed. Participants will be randomly assigned in a crossover trial to (1) MyTPill x 3 mos, then WisePill x 3 mos; or (2) Wisepill x 3 mos, then MyTPill x 3 mos. Adherence measured via MyTPill and WisePill will be compared to dried blood spot (DBS) concentrations of tenofovir diphosphate (for cumulative adherence) and emtricitabine triphosphate (for recent adherence). Participants will provide DBS samples on multiple random times according to a schedule that prevents anticipation of sampling but which assesses cumulative/recent ART adherence. We will also examine which aspects of prescription opioid use, pain, withdrawal, and demographic, social, structural, and other environmental contexts (measured by timeline follow back and quantitative interviews) are most closely linked to ART adherence. Furthermore, we will examine how these aspects affect MyTPill and WisePill measures of ART adherence. Primary Aim: Determine if MyTPill, as compared to Wisepill, exhibits: (1) better measures recent and cumulative ART adherence when using DBS as the “gold standard”; and (2) better participant experience as assessed by observed and self-reported measures (e.g., study retention, fidelity to study, protocol relative subjective index, qualitative interviews). Secondary Aim: Examine which aspect(s) of prescription opioid use (e.g., prescribed use/misuse of opioids as measured by MyTPill, technology subversion, pain, demographic, social, other structural factors) are most closely linked to ART nonadherence (per DBS), and how they affect measuring ART adherence using MyTPill and Wisepill. Public health significance: If MyTPill, a non-invasive, self-contained, and nearly automated ART EAM, is superior to other strategies, it will serve as a platform for subsequent research testing real-time ART adherence interventions; 2) specific factors associated with suboptimal ART adherence can be addressed with interventions directed towards HIV+ persons receiving prescription opioids; and 3) MyTPill can directly address the crisis of opioid misuse arising from treatment of chronic pain.