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

 描述(由申请人提供)：高水平地坚持抗逆转录病毒疗法(ART)对于实现艾滋病毒治疗目标至关重要，例如持续抑制血浆艾滋病毒RNA，降低产生耐药性的风险，提高生活质量，降低艾滋病毒传播风险。评估抗逆转录病毒治疗依从性的常用方法包括患者自我报告、药房续药数据、药片计数、用药事件监测系统(MEMS)上限或生物基质(如血浆和头发)中的药物水平分析。然而，没有黄金标准，临床医生和研究人员必须求助于最可行和最具成本效益的方法，这可能会导致对依从性的偏见或不准确的估计。我们寻求另一种方法，这种方法比自我报告更客观，在解释结果时不需要实验室分析或专业知识，并且可以在广泛的医疗系统和研究环境中以更少的时间和财政资源进行。参与者将使用移动电话拍摄他们的药瓶(照片中显示了补药日期)和药瓶/药盒中的内容物的照片，并每月将这些照片发送到研究的手机号码，以根据药店的补药日期和药片数量来评估遵守情况。在小样本参与的形成阶段，我们将检查研究方案和程序的可理解性，并在三个月的时间内确定我们遵守措施的准确性。在主要研究中，我们将检查使用短信发送的ART小瓶照片和药物小瓶/药瓶/药盒的内容物，以基于六个月内的药房重新灌装日期和药片数量来估计依从性。我们研究项目的目的是：(1)评估一种新的方法的可行性和可接受性，该方法使用拍照和短信的药房充填日期来估计ART依从性；(2)检查一项研究的可行性和可接受性，其中招募、同意、头发样本收集、短信和离职访谈都将被远程进行；以及(3)探索根据短信发送的药店充填日期和药丸数量的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 我们的新方法将是可行的、可接受的和准确的，可以使用通过短信照片在艾滋病毒携带者中获得的药房重新灌装日期和药片数量来远程估计抗逆转录病毒治疗的依从性。如果可行和可接受，这种估计ART依从性的方法可以用于临床实践或早期可以检测到ART不依从性的干预研究，这可能有助于将病毒学失败的风险降至最低，降低疾病进展的风险，并减少耐药病毒的传播。此外，对完全远程研究方法的可行性和可接受性的评估对于未来的研究项目非常重要，因为在这些项目中，耻辱或实际交通可能是参与的一个重大障碍。我们将使用这些数据在随后的大规模依从性试验中为所建议的方法提供信息。

 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.