The ethics of electronic adherence monitoring for HIV research and care in Uganda

描述(由申请人提供)：电子依从性监测(EAM)被广泛应用于艾滋病毒研究；然而，我们对EAM的伦理理解有限。拟议的研究将调查EAM的理论和用户观点，以确保在基于EAM的艾滋病毒研究和护理中为参与者提供最佳保护。创新：拟议的研究具有创新性，原因有几个：1)这是第一次彻底研究围绕使用EAM技术的伦理问题；2)它将利用非电子遵守情况监测和其他领域的见解，为EAM制定一个规范性框架；3)它将通过持续进行的关于乌干达农村地区艾滋病毒抗逆转录病毒治疗坚持使用的纵向队列研究，收集关于EAM使用的经验数据，这将与哲学研究融为一体；4)它将把伦理见解转化为对乌干达以及可能在其他环境中进行的艾滋病毒研究(及衍生护理)的实际建议。方法：我们将首先参考伦理文献，并初步了解eAM在HIV研究和护理中使用的潜在伦理问题，包括机密性、隐私、数据安全、自主权、信任、尊重和 辅助护理义务。我们的重点将放在可能的资源有限的环境上。然后，我们将通过在乌干达农村地区对感染艾滋病毒的成年人进行Wisepill监测的持续纵向观察性队列，从多个角度收集初步数据(R01MH054907，PI：Bangsberg)。这些数据将突出乌干达农村地区最令人担忧的伦理问题，并丰富我们的初步理解。然后，我们将制定在乌干达农村和类似环境中使用EAM进行艾滋病毒研究和护理的伦理建议。我们提出了以下目标：1.为EAM在HIV研究中的使用制定一个初步的规范性框架(即，一般伦理建议可根据经验数据进行修改和规范)。2.经验性地评估患者、研究人员、机构审查委员会、临床医生和社区对EAM在乌干达农村地区艾滋病毒研究中使用的看法。3.利用经验数据(目标2)丰富规范框架(目标1)，并为乌干达农村和类似环境中基于EAM的艾滋病毒研究编写示范伦理建议，并可能将其应用于临床护理。研究人员：Haberer博士(Pi)是实时ART依从性监测的新兴学术领袖，特别是在资源有限的环境中。埃亚尔博士(PI)是一位具有丰富经验的生物伦理学家，致力于解决全球健康和依从性问题，并对与电子监测相关的现代哲学和伦理问题提供了重要的见解。Musiimenta博士(Site PI)在乌干达农村地区艾滋病毒/艾滋病相关信息系统的混合方法评估方面提供了重要经验。

DESCRIPTION (provided by applicant): Electronic adherence monitoring (EAM) is widely used in HIV research; however, our understanding of the ethics of EAM is limited. The proposed study will investigate theoretical and user perspectives on EAM to ensure optimal protection for participants in EAM-based HIV research and care. Innovation: The proposed study is innovative for several reasons: 1) it is the first study to thoroughly examine ethical issues surrounding the use of EAM technology; 2) it will leverage insights from non-electronic adherence monitoring and other fields to develop a normative framework for EAM; 3) it will involve empiric data collection on EAM use through an ongoing longitudinal cohort study of adherence to HIV antiretroviral therapy in rural Uganda, which will be fused with philosophical research; and 4) it will translate ethics insights into practical recommendations for HIV research (and derivatively care) in Uganda and potentially in other settings. Approach: We will first consult the ethics literature and develop a preliminary sense of potential ethical concerns about EAM use in HIV research and care, including confidentiality, privacy, data security, autonomy, trust, respect, and ancillary care obligations. Our focus will be on resource-limited settings where possible. We will then collect primary data from multiple perspectives through an ongoing longitudinal, observational cohort of HIV-infected adults who are monitored with Wisepill in rural Uganda (R01MH054907, PI: Bangsberg). These data will highlight those ethical concerns that loom largest in rural Uganda and enrich our preliminary understanding. We will then develop ethical recommendations for use of EAM in HIV research and care in rural Uganda and similar settings. We propose the following aims: 1. Develop a preliminary normative framework (i.e., general ethical recommendations subject to modification and specification per empiric data) for the use of EAM in HIV research. 2. Empirically assess patient, researcher, institutional review board, clinician, and community perspectives about EAM use in HIV research in rural Uganda. 3. Use empirical data (Aim 2) to enrich the normative framework (Aim 1) and prepare model ethical recommendations for EAM-based HIV research in rural Uganda and similar settings, with potential applications for clinical care. Investigators: Dr. Haberer (PI) is the emerging academic leader of real-time ART adherence monitoring, particularly in resource-limited settings. Dr. Eyal (PI) is a bioethicist with extensive experience addressing topics in global health and adherence, and provides essential insight into modern philosophical and ethical issues related to electronic monitoring. Dr. Musiimenta (Site PI) provides key experience in mixed method evaluation of HIV/AIDS-related information systems in rural Uganda.