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; 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。很遗憾， 诸如Wisepill之类的EAM假设，但无法验证口服药物的实际摄入。相反，我/治疗/药丸 （mytpill），一种直接测量摄入的创新技术，包括包含药物和药物的数字药丸 明胶胶囊中的微型无线电发射极。当摄入数字药丸时，胃含量会溶解胶囊以激活 发射极。数字药丸“同步”实时摄入数据到智能手机应用程序，以提供生动，无可争议的测量 药物摄入。但是，EAM的正面比较尚未进行。确定上级 EAM将通过实现实时干预措施来支持艺术依从性来改善病毒学抑制。在这个 随机对照试验，我们将在n = 80 HIV+男性/女性服用处方Ooids中比较Mytpill与Wisepill 每日一次的ART方案，其中含有替诺福韦和Emtricitabine，病毒载荷> 200/mL。 HIV+患者 处方阿片类药物很难遵守艺术方案，尽管原因尚不清楚。给定高 艾滋病毒+个体中处方oid missuse的流行率（艾滋病毒阴性人的三重）和惊人的率 次优艺术的依从性（比没有错过的人差46％），以改善艺术依从性的策略 人口至关重要。参与者将在交叉试验中随机分配给（1）mytpill x 3 mos，然后 Wisepill x 3 mos;或（2）Wisepill x 3 mos，然后是mytpill x 3 mos。通过mytpill和Wisepill测量的依从性将是 与替诺福韦双磷酸盐（用于累积依从性）和伊姆特雷列他滨的干血点（DBS）浓度相比 三磷酸（最近遵守）。参与者将根据一个随机时间提供DBS样本 时间表可以防止预期采样但评估累积/最近的艺术依从性。我们也会 检查处方使用，疼痛，戒断和人口，社交，结构和其他方面的各个方面 环境环境（通过时间轴衡量跟随和定量访谈）与艺术最紧密相关 坚持。此外，我们将研究这些方面如何影响mytpill和Wisepill的艺术依从性。 主要目的：确定Mytpill是否与Wisepill相比是否展示：（1）更好的措施和累积艺术 使用DBs作为“黄金标准”时的依从性； （2）观察到的更好的参与经验和 自我报告的措施（例如，研究保留，研究忠诚度，协议相对主观指数，定性访谈）。 次要目的：检查处方OID使用的哪个方面（例如，按照所测量的OIDS使用/MISSUSE 通过mytpill，技术颠覆，痛苦，人口统计，社会，其他结构性因素）与艺术最密切相关 不遵守（每个DB），以及它们如何使用mytpill和wisepill影响衡量艺术依从性。公共卫生 意义：如果mytpill，一种非侵入性，独立且几乎是自动化的艺术，它优于其他策略 将作为随后的研究测试实时艺术依从性干预措施的平台； 2）具体因素 可以通过针对艾滋病毒+人接受的干预措施来解决与次优艺术依从性相关的 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危机。