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

MyTPill：监测 HIV 处方阿片类药物使用者抗逆转录病毒依从性的新策略

• 批准号: 10116617
• 负责人: Edward W Boyer
• 金额: $ 6.24万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10116617
• 关键词: Acids; Address; Adherence; Adult; Affect; Anti-Retroviral Agents; Back; Behavior; Biological Markers; Blood; Cellular Phone; Clinical Trials; Cross-Over Trials; Demographic Factors; Detection; Devices; Diphosphates; Dose; Environmental Risk Factor; Event; Exhibits; Frequencies; Gelatin; Gold; HIV; HIV Seronegativity; HIV antiretroviral; High Prevalence; Individual; Ingestion; Intervention; Interview; Investigation; Link; Measures; Methods; Monitor; Opioid; Oral Ingestion; Pain; Participant; Patient Self-Report; Patients; Pattern; Persons; Pharmaceutical Preparations; Population; Protocols documentation; Public Health; Radio; Randomized; Randomized Controlled Trials; Reader; Regimen; Reporting; Research; Sampling; Schedule; Severities; Spottings; Stomach; Structure; Technology; Tenofovir; Testing; Time; TimeLine; Viral; Viral Load result; Withdrawal; Woman; antiretroviral therapy; arm; base; capsule; chronic pain; data ingestion; design; digital; emtricitabine; experience; head-to-head comparison; high risk population; improved; indexing; innovative technologies; medication compliance; men; multimodality; novel; novel strategies; opioid epidemic; opioid misuse; opioid use; opioid user; pill; prescription opioid; prescription opioid misuse; prevent; radio frequency; smartphone Application; social; social factors; social structure; therapy adherence; transmission process; tripolyphosphate; usability; virology

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.

项目摘要/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依从性。不幸的是， 像Wisepill这样的EAMS假定但不能核实实际摄入的口服药物。相比之下，我的/治疗/药片 (MyTPill)是一项直接测量摄入量的创新技术，包括一种含有药物和 明胶胶囊里的微型无线电发射器。当数字药丸被摄取时，胃内容物溶解胶囊以激活 发射器。这种数字药丸将实时摄取数据同步到智能手机应用程序中，以提供生动、无可争辩的测量方法 药物摄取的记录。然而，EAMS的面对面比较尚未进行。确定上级 EAM将通过支持实时干预来支持抗逆转录病毒疗法的坚持，从而改善病毒学抑制。在这 随机对照试验，我们将在N=80名HIV+服用处方阿片类药物的男性/女性中比较MyTPill和WisePill 以及每日一次的ART方案，其中含有病毒载量为200/毫升的替诺福韦和恩曲他滨。HIV+患者正在接受 处方类阿片难以坚持ART疗法，尽管原因尚不完全清楚。考虑到高价 艾滋病毒携带者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--以及惊人的比率 次优的ART依从性(比没有滥用的人差46%)，在这方面提高ART依从性的策略 人口是迫切需要的。参与者将在交叉试验中被随机分配到(1)MyTPill×3 MOS，然后 WisePill×3个月；或(2)Wisepill×3个月，然后MyTPill×3个月。通过MyTPill和WisePill衡量的依从性将是 与干血斑(DBS)相比，替诺福韦二磷酸(累积粘附性)和恩曲他滨的浓度 三磷酸(用于最近的粘合)。参赛者将在多个随机时间根据 防止预期抽样，但评估累积/最近的ART遵守情况的时间表。我们还将 检查处方阿片类药物使用、疼痛、戒断以及人口、社会、结构等方面的哪些方面 环境背景(通过时间线回访和定量采访来衡量)与艺术联系最密切 坚持不懈。此外，我们将研究这些方面如何影响MyTPill和WisePill对ART依从性的测量。 主要目的：确定MyTPill与Wisepill相比是否表现出：(1)更好地衡量最近和累积的ART 使用DBS作为“黄金标准”时的坚持；以及(2)通过观察和评估的更好的参与者体验 自我报告测量(例如，学习保持、对研究的忠诚度、礼仪相对主观指数、定性访谈)。 次要目标：审查处方阿片类药物使用的哪个方面(S)(例如，所测量的处方使用/滥用阿片类药物 通过MyTPill，技术颠覆、痛苦、人口、社会、其他结构性因素)与艺术联系最密切 不依从性(根据DBS)，以及它们如何影响使用MyTPill和Wisepill衡量ART依从性。公共卫生 意义：如果MyTPill，一个非侵入性的，自给自足的，几乎自动化的ART EAM，比其他策略更好，它 将作为后续研究测试实时ART依从性干预的平台；2)具体因素 与次优抗逆转录病毒疗法的依从性相关的问题可以通过针对HIV+患者的干预措施来解决 处方阿片类药物；以及3)MyTPill可以直接解决因治疗慢性疼痛而导致的阿片类药物滥用危机。