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: 10380990
• 负责人: Edward W Boyer
• 金额: $ 2.34万
• 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 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10380990
• 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; efficacy evaluation; 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治疗依从性。 Wisepill 等 EAM 假设但无法验证口服药物的实际摄入情况，而 My/Treatment/Pill 则相反。 （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和 明胶胶囊中的微型无线电发射器当摄入数字药丸时，胃内容物会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、无可争议的测量结果。 然而，尚未对 EAM 进行头对头比较，以确定其优劣。 EAM 将通过实时干预来支持 ART 依从性，从而改善病毒抑制。 随机对照试验，我们将在 N=80 名服用处方阿片类药物的 HIV+ 男性/女性中比较 MyTPill 和 WisePill 每日一次的 ART 治疗方案包含病毒载量 >200/mL 的替诺福韦和恩曲他滨。 处方阿片类药物很难遵守 ART 治疗方案，但原因尚不完全清楚。 HIV+ 个体中处方阿片类药物滥用的发生率（HIV 阴性者的三倍）和惊人的比率 次优 ART 依从性（比那些没有滥用的人差 46%），提高 ART 依从性的策略 参与者将在交叉试验中被随机分配到 (1) MyTPill x 3 个月，然后 WisePill x 3 个月；或 (2) WisePill x 3 个月，然后通过 MyTPill 和 WisePill 测量 MyTPill x 3 个月。 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（用于最近的遵守情况）。参与者将根据a随机多次提供DBS样本。 我们还将制定防止抽样预期但评估累积/近期 ART 遵守情况的时间表。 检查处方阿片类药物使用、疼痛、戒断以及人口、社会、结构和其他方面的哪些方面 环境背景（通过时间线跟踪和定量访谈来衡量）与 ART 的联系最为密切 此外，我们将研究这些方面如何影响 MyTPill 和 WisePill 的 ART 依从性测量。 主要目标：确定 MyTPill 与 Wisepill 相比是否表现出：(1) 更好地衡量近期和累积的 ART 当使用 DBS 作为“黄金标准”时；(2) 通过观察和评估获得更好的参与者体验； 自我报告的措施（例如，学习保留、学习忠诚度、方案相对主观指数、定性访谈）。 次要目标：检查处方阿片类药物使用的哪些方面（例如，所测量的阿片类药物的处方使用/滥用） 根据 MyTPill 的说法，技术颠覆、痛苦、人口、社会、其他结构因素）与 ART 的联系最为密切 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。 意义：如果说 MyTPill 这种无创、独立且近乎自动化的 ART EAM 优于其他策略，那么它 将作为后续研究测试实时 ART 依从性干预措施的平台；2）特定因素； 与次优 ART 依从性相关的问题可以通过针对接受治疗的 HIV + 患者进行干预来解决 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。