Developing and Evaluating a Provider-Delivered National EMR Alert-based HIV ART Adherence Counseling Program in Haiti: iSanté Plus

摘要 保护艾滋病毒携带者的健康，结束艾滋病毒的流行 有赖于扩大抗逆转录病毒治疗的途径和确保治疗成功。在海地，这个国家最 在加勒比地区，受艾滋病毒/艾滋病的严重影响，抗逆转录病毒疗法的使用大幅增加； 然而，考虑到磨耗程度、次优依从性和疑似治疗失败 已经被观察到了。建立在初步研究的基础上，确定了 基于电子病历(EMR)的警报，拟议的研究项目将开发和 试点使用电子警报和简要的ART测试基于提供商的干预 坚持咨询，提高ART依从性，降低ART治疗发生率 失败了。这一创新干预利用了现有的全国范围的iSantéEMR系统，并 通过有针对性地对护理提供和患者依从性产生广泛影响的潜力 向最需要的人提供稀缺的人员和资源。该项目的目标是：1) 对电子病历警报和医疗保健提供者在抗逆转录病毒治疗中的潜在作用进行形成性研究 海地艾滋病毒初级保健诊所的依从性咨询；以及2)进行初步临床 ISantéPlus干预的审判。将进行涉及混合方法的研究性研究 在太子港的两家大型公共部门艺术诊所，多学科MPI 研究团队在之前十年的合作中建立了关系。一位形成者 使用混合方法的评估阶段将检查提供者和患者的信念和态度 走向基于电子病历的警报和基于提供者的艺术依从性咨询。这项工作将 告知iSantéPlus干预措施的设计和开发。一项可行性的初步研究 并使用准实验研究设计进行干预的可接受性 在一次干预和一次对照ART诊所。令人感兴趣的结果包括保留在护理中， 世界卫生组织免疫学和临床标准的ART依从性、ART治疗失败发生率 (全部使用常规电子病历数据测量)和艾滋病毒病毒抑制(使用HIV-1病毒测量 在患者的子样本中进行负载测试)。患者信息、动机和行为将是 被视为中介因素。大约130名讲克里奥尔语的海地老年患者 18名最近开始了一线抗逆转录病毒疗法的人预计将被纳入这项研究 并随访9个月。虽然研究设计和样本量不会被提供动力 衡量干预措施的有效性，试验将确定可行性、可接受性和 与使用整群随机或阶梯楔形试验的较大规模试验相关的研究程序 海地国家一级的研究设计。

Abstract Preserving the health of patients living with HIV and achieving an end to the HIV epidemic depend upon expanding ART access and assuring treatment success. In Haiti, the country most heavily impacted by HIV/AIDS in the Caribbean region, use of ART has scaled up dramatically; however, concerning levels of attrition, sub-optimal adherence, and suspected treatment failure have been observed. Building upon preliminary research establishing the validity of an electronic medical record (EMR)–based alert, the proposed research project will develop and pilot test a provider-based intervention using an electronic alert together with brief ART adherence counseling to improve ART adherence and reduce the incidence of ART treatment failure. This innovative intervention leverages the existing nation-wide iSanté EMR system and offers potential for wide-scale impact on care delivery and patient adherence, by targeting scarce personnel and resources toward those most in need. The aims of the project are to: 1) conduct formative research on the potential role of EMR alerts and healthcare providers in ART adherence counseling in Haitian HIV primary care clinics; and 2) conduct a preliminary clinical trial of the iSanté Plus intervention. The research study involving mixed methods will take place in two large public-sector ART clinics in Port-au-Prince, where the multidisciplinary MPI research team has establish relations during a decade of prior collaborations. A formative evaluation phase using mixed methods will examine provider and patient beliefs and attitudes toward the EMR-based alert and provider-based ART adherence counseling. This work will inform the design and development of the iSanté Plus intervention. A pilot study of the feasibility and acceptability of the intervention using a quasi-experimental study design will be carried out in one intervention and one control ART clinic. Outcomes of interest include retention in care, ART adherence, incidence of ART treatment failure by WHO immunologic and clinical criteria (all measured using routine EMR data), and HIV viral suppression (measured using HIV-1 viral load testing in a sub-sample of patients). Patient information, motivation, and behavior will be examined as mediating factors. Approximately 130 Haitian, Creole-speaking patients over age 18 who have recently initiated a first-line ART regimen are expected to be enrolled in the study and to be followed for 9 months. While the study design and sample size will not be powered to measure effectiveness of the intervention, the trial will establish feasibility, acceptability, and study procedures relevant for a larger-scale trial using a cluster randomized or stepped-wedge study design at a national level in Haiti.