Rx Pix: A Novel Way to Assess Antiretroviral Adherence with Pharmacy Refill Dates

Rx Pix：通过药房补充日期评估抗逆转录病毒药物依从性的新方法

• 批准号: 9063884
• 负责人: Parya Saberi
• 金额: $ 23.78万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-02-19 至 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9063884
• 关键词: Adherence; Anti-Retroviral Agents; Biological Assay; Biological Markers; Car Phone; Cellular Phone; Clinic; Clinical Research; Collection; Complex; Computerized Medical Record; Consent; Data; Data Collection; Disease Progression; Drug resistance; Drug usage; Early Diagnosis; Electronic drug monitoring; Event; Exploratory/Developmental Grant for Diagnostic Cancer Imaging; Failure; Feasibility Studies; Fumarates; Goals; Gold; HIV; Hair; Health Care Research; Healthcare Systems; Home environment; Image; Individual; Ingestion; Intervention Studies; Interview; Laboratories; Length; Life; Link; Measures; Medical Records; Methodology; Methods; Monitor; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacy facility; Phase; Plasma; Procedures; Protocols documentation; Quality of life; RNA; Records; Recruitment Activity; Regimen; Research; Research Methodology; Research Personnel; Research Project Grants; Resort; Resources; Risk; Sampling; Social Desirability; System; Technology; Telephone; Tenofovir; Text; Time; Transportation; Validation; Vial device; antiretroviral therapy; base; clinical care; clinical practice; cost; cost effective; drug resistant virus; experience; improved; innovation; novel; novel strategies; pill; public health relevance; response; retention rate; sample collection; social stigma; therapy adherence; transmission process; treatment adherence

 DESCRIPTION (provided by applicant): High levels of adherence to antiretroviral therapy (ART) is critical for attaining HIV treatment goals, such as sustained suppression of plasma HIV RNA, decreased risk of developing drug resistance, improved quality of life, and reduced risk of HIV transmission. Commonly used methods to assess ART adherence include patient's self-report, pharmacy refill data, pill counts, medication event monitoring system (MEMS) caps, or analysis of drug levels in a biomatrix (e.g., plasma and hair). However, there is no gold standard and clinicians and researchers must resort to the most feasible and cost-effective methods possible, which may result in biased or inaccurate estimates of adherence. We seek an alternative approach, which is more objective than self-report, does not require laboratory assays or expertise in the interpretation of results, and can be conducted with less time and financial resources in a wide range of healthcare systems and research settings. Using mobile telephones, participants will take photos of their medication vials (demonstrating the refill date n the photo) and the contents of their medication vials/pillboxes and text these photos to the study's mobile telephone number on a monthly basis to assess adherence based on pharmacy refill dates and pill counts. In a formative phase with a small sample of participants, we will examine comprehensibility of the study protocol and procedures and establish accuracy of our adherence measures over a three-month period. In the main study, we will examine the use of text messaged photos of ART vials and contents of medication vials/pillboxes to estimate adherence based on pharmacy refill dates and pill counts over six months. The aims of our research project are to: (1) Assess the feasibility and acceptability of a novel method of estimating ART adherence using photographed and text messaged pharmacy refill dates; (2) Examine the feasibility and acceptability of a study where recruitment, consent, hair sample collection, text messaging, and exit interviews will all be conducted remotely; and (3) Explore the relationship between adherence calculated based on text messaged photos of pharmacy refill dates and pill counts to an objective measure using drug levels in hair. We hypothesize that our novel approaches to remotely estimate ART adherence using pharmacy refill dates and pill counts obtained via text messaged photos among people living with HIV will be feasible, acceptable, and accurate. If feasible and acceptable, this method of estimating ART adherence can be used in clinical practice or for intervention studies where ART non-adherence can be detected early on, which can potentially help to minimize risk of virologic failure, decrease the risk of disease progression, and reduce transmission of drug- resistant virus. Additionally, the assessment of the feasibility and acceptability of an entirely remote research methodology is important for future research projects where stigma or physical transportation may be a significant barrier to participation. We will use these data to inform the proposed methods in subsequent large- scale adherence trials.

 描述（由申请人提供）：高水平的抗逆转录病毒治疗（ART）依从性对于实现HIV治疗目标至关重要，例如持续抑制血浆HIV RNA、降低耐药性风险、改善生活质量和降低HIV传播风险。评估ART依从性的常用方法包括患者的自我报告、药房再填充数据、药丸计数、药物事件监测系统（MEMS）帽或生物基质（例如，血浆和毛发）。然而，没有金标准，临床医生和研究人员必须采取最可行和最具成本效益的方法，这可能导致对依从性的偏倚或不准确的估计。我们寻求一种替代方法，这种方法比自我报告更客观，不需要实验室检测或结果解释方面的专业知识，并且可以在广泛的医疗保健系统和研究环境中以更少的时间和财政资源进行。使用移动的电话，受试者将拍摄其药瓶的照片（在照片上显示再填充日期）和药瓶/药盒的内容物，并每月将这些照片发送到研究的移动的电话号码，以根据药房再填充日期和药丸计数评估依从性。在一个小样本参与者的形成阶段，我们将检查研究方案和程序的可理解性，并在三个月内建立我们的依从性指标的准确性。在主要研究中，我们将检查使用ART小瓶的短信照片和药瓶/药盒的内容物，根据药房续药日期和六个月内的药丸数量来估计依从性。我们研究项目的目的是：（1）评估一种新方法的可行性和可接受性，该方法使用照片和短信记录药房续药日期来估计ART依从性;（2）检查一项研究的可行性和可接受性，该研究的招募、同意、头发样本收集、短信和离职面谈都将远程进行;以及（3）探索基于药房续药日期和药丸计数的文本消息照片计算的依从性与使用头发中的药物水平的客观测量之间的关系。我们假设 我们的新方法是通过艾滋病毒感染者的短信照片获得的药房续药日期和药丸数量来远程估计抗逆转录病毒治疗的依从性，这是可行的、可接受的和准确的。如果可行且可接受，这种估计ART依从性的方法可用于临床实践或用于干预研究，其中可早期检测ART不依从性，这可能有助于最大限度地降低病毒学失败的风险，降低疾病进展的风险，并减少耐药病毒的传播。此外，评估完全远程研究方法的可行性和可接受性对于未来的研究项目非常重要，因为耻辱或物理运输可能是参与的重大障碍。我们将使用这些数据为后续大规模依从性试验中提出的方法提供信息。