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

在海地制定和评估由医疗服务提供者提供的基于 EMR 警报的国家 HIV ART 依从咨询计划：iSanté Plus

• 批准号: 9340292
• 负责人: Nancy Puttkammer
• 金额: $ 23.11万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9340292
• 关键词: AIDS/HIV problem; Adherence; Adult; Age; Americas; Attitude; Balan; Behavior; Belief; Caribbean region; Caring; Cause of Death; Clinic; Clinical; Clinical Trials; Collaborations; Communication; Computer software; Computerized Medical Record; Counseling; Country; Data; Development; Drug resistance; Eligibility Determination; Enrollment; Epidemic; Evaluation; Failure; Feasibility Studies; Feedback; Focus Groups; HIV; HIV antiretroviral; HIV drug resistance; HIV-1; Haiti; Haitian; Health; Health Personnel; Health Services; Health system; Hospital Departments; Human Resources; Immunologics; Incidence; International; Intervention; Intervention Studies; Intervention Trial; Letters; Measures; Mediating; Methods; Modeling; Motivation; Outcome; Outcome Measure; Patients; Peripheral; Phase; Pilot Projects; Preparation; Prevalence; Primary Health Care; Procedures; Protocols documentation; Provider; Psychosocial Assessment and Care; Public Health Informatics; Public Sector; Qualitative Evaluations; Qualitative Methods; Quantitative Evaluations; Questionnaires; Randomized; Regimen; Research; Research Design; Research Personnel; Research Project Grants; Resources; Risk; Role; Sample Size; Sampling; Services; Site; Structure; System; Testing; Therapeutic; Training; Training Activity; Treatment Efficacy; Treatment Failure; Viral; Viral Load result; Visit; Work; antiretroviral therapy; base; care delivery; clinical care; compliance behavior; cost; cost efficient; design; disability; effectiveness measure; experimental study; formative assessment; improved; individual patient; innovation; interest; multidisciplinary; prediction algorithm; programs; public health relevance; research study; scale up; skills; success; therapy adherence

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.

摘要 保护艾滋病毒感染者的健康，实现艾滋病毒流行的终结 这取决于扩大抗逆转录病毒疗法的普及和确保治疗成功。在海地， 在加勒比地区，艾滋病毒/艾滋病的严重影响使抗逆转录病毒疗法的使用急剧增加; 然而，考虑到损耗水平、次优依从性和疑似治疗失败， 已经被观察到了。在初步研究的基础上， 电子病历（EMR）为基础的警报，拟议的研究项目将开发和 使用电子警报和简短的ART对基于提供者的干预进行试点测试 依从性咨询，以提高ART依从性并降低ART治疗的发生率 失败这种创新的干预措施利用了现有的全国性iSanté EMR系统， 提供了广泛的潜在影响，对护理服务和病人的依从性， 将稀缺的人力和资源用于最需要帮助的人。该项目的目标是：1） 对EMR警报和医疗保健提供者在ART中的潜在作用进行形成性研究 海地艾滋病初级保健诊所的依从性咨询; 2）进行初步临床 iSanté Plus干预试验。将进行涉及混合方法的研究 在太子港的两个大型公共部门ART诊所，多学科MPI 研究团队在之前的十年合作中建立了关系。形成性 评估阶段采用混合方法，将检查提供者和患者的信念和态度 以EMR为基础的警报和提供者为基础的ART依从性咨询。这项工作将 为iSanté Plus干预措施的设计和开发提供信息。可行性试验研究 将采用准实验研究设计进行干预的可接受性 在一个干预和一个对照ART诊所。感兴趣的结果包括保持护理， 抗逆转录病毒治疗依从性，按照WHO免疫学和临床标准列出的抗逆转录病毒治疗失败发生率 (all使用常规EMR数据测量）和HIV病毒抑制（使用HIV-1病毒抑制测量）。 在患者的子样本中进行负荷测试）。患者信息、动机和行为将被 作为中介因素进行研究。大约130名海地人，讲克里奥尔语的病人， 18名最近开始一线抗逆转录病毒疗法的患者预计将入组本研究 并随访9个月。虽然研究设计和样本量将不足以 衡量干预措施的有效性，试验将确定可行性，可接受性， 与使用整群随机化或步进楔形试验的大规模试验相关的研究程序 在海地进行国家一级的研究设计。