A nurse-led intervention to extend the HIV treatment cascade for cardiovascular disease prevention (EXTRA-CVD)

由护士主导的干预措施，旨在扩大艾滋病毒治疗级联以预防心血管疾病 (EXTRA-CVD)

• 批准号: 10470074
• 负责人: Hayden B Bosworth
• 金额: $ 12.88万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2021-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10470074
• 关键词: AIDS/HIV problem; Achievement; Address; Adherence; Adopted; Adoption; Adult; Atherosclerosis; Blood; Blood Pressure; Cardiovascular Diseases; Caring; Case Manager; Categories; Cholesterol; Clinic; Clinical; Communication; Computerized Medical Record; Data; Diagnosis; Dose; Education; Environment; Evaluation; Event; General Population; Goals; Guidelines; HIV; HIV Infections; Health; Health Services Accessibility; High Density Lipoprotein Cholesterol; Home Blood Pressure Monitoring; Hyperlipidemia; Hypertension; Improve Access; Individual; Intervention; Interview; Lipids; Maintenance; Measures; Methods; Modeling; Nurses; Outcome; Participant; Pathway Analysis; Patient Care Team; Patients; Perception; Pharmaceutical Preparations; Physicians; Population; Prevention; Prevention education; Preventive care; Preventive therapy; Primary Health Care; Process; Process Measure; Protocols documentation; Provider; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Registries; Risk; Site; Specialist; Surveys; Testing; Treatment Step; Trust; United States; University Hospitals; Viral; Viral Load result; acceptability and feasibility; antiretroviral therapy; atherosclerosis risk; base; blood pressure regulation; cardiovascular disorder prevention; cardiovascular disorder risk; care coordination; care providers; cholesterol control; clinically significant; comorbidity; design; effectiveness clinical trial; ethnic diversity; evidence base; experience; high risk; hypercholesterolemia; hypertension treatment; improved; informant; innovation; interest; intervention effect; iterative design; medical specialties; member; multi-component intervention; multidisciplinary; nursing intervention; prevent; prevention evaluation; preventive intervention; primary outcome; racial diversity; recruit; risk perception; screening; secondary outcome; support tools; treatment arm; trial design; uptake

People living with HIV (PLHIV) are at increased risk for atherosclerotic cardiovascular disease (ASCVD); however, uptake of evidence based therapies to prevent ASCVD is sub-optimal. Reasons for under treatment may include low perceived risk, competing priorities for HIV specialist providers, and poor trust and communication with non-HIV primary care providers. This project proposes a nurse-led intervention to extend the HIV/AIDS treatment cascade—a widely adopted framework developed to improve access to high quality HIV care—for CVD prevention, specifically to improve control of blood pressure and hyperlipidemia in PLHIV on antiretroviral therapy who have suppressed HIV viral load. The study will be conducted in three racially and ethnically diverse clinic contexts [University Hospitals (Cleveland, OH), MetroHealth (Cleveland, OH) and Duke Health (Durham, NC)] that are broadly representative of HIV specialty care in the US. Using a mixed-methods clinical effectiveness trial design, this project will test the 12-month efficacy of a multi-component intervention among n=300 HIV+ adults on suppressive ART with hypertension and hyperlipidemia. Participants will be randomized 1:1 to intervention vs. education control. Control participants will receive general prevention education. The intervention will consist of four evidence-based components derived from prior studies in the general population: (1) nurse-led care coordination, (2) nurse- managed medication protocols and adherence support (3) home BP monitoring, and (4) electronic medical records (EMR) support tools. These components will be further adapted to the HIV specialty clinic context with key stakeholder input and using data from a mixed-methods study of current ASCVD preventive care practices at the three HIV clinic sites. The primary outcome will be change in systolic blood pressure and secondary outcome will be change in non-HDL cholesterol. The tertiary outcome will be the change is the proportion of participants in the following extended cascade categories: (1) appropriately diagnosed with hypertension and hyperlipidemia (2) appropriately managed; (3) at treatment goal (systolic blood pressure <140mmHg and non-HDL cholesterol < National Lipid Association targets). The study will have >80% power to detect a 6mmhg lower systolic BP and >90% power to detect a 15mg/dL lower non-HDL cholesterol in the intervention arm vs. education control. A process evaluation of the prevention nurse intervention will be conducted, which will assess fidelity, dose, recruitment, reach, and context. Two key contextual process measures of interest will be changes in perceived ASCVD risk and changes in trust and communication between PLHIV participants and their HIV and non-HIV providers. If proven effective to reduce both blood pressure and cholesterol as postulated, our nurse-led intervention will have substantial clinical impact among high-risk PLHIV, potentially reducing ASCVD events by more than a quarter. This model is potentially scalable as an extension of HIV treatment cascade initiatives nationwide.

艾滋病毒（PLHIV）患者患动脉粥样硬化心血管疾病（ASCVD）的风险增加； 但是，预防ASCVD的基于证据的疗法是最佳的。治疗的原因 可能包括低感知风险，艾滋病毒专家提供者的竞争优先级，以及信任差， 与非HIV初级保健提供者的沟通。该项目建议由护士主导的干预措施 扩展艾滋病毒/艾滋病治疗级联 - 开发了一个广泛的采用框架，以提高获得高位的机会 优质的艾滋病毒护理 - 预防CVD，特别是为了改善血压的控制和 抑制HIV病毒载量的抗逆转录病毒疗法中PLHIV中的高脂血症。该研究将是 在三个大致和种族多元化的诊所环境中进行[大学医院（俄亥俄州克利夫兰）， Metrohealth（俄亥俄州克利夫兰）和Duke Health（北卡罗来纳州达勒姆）]，它们是HIV专业的广泛代表 在美国关心。使用混合方法临床有效性试验设计，该项目将测试12个月 N = 300 HIV+成年人对高血压的抑制作用的多组分干预的功效 和高脂血症。参与者将被随机分配给干预与教育控制。控制 参与者将接受一般预防教育。干预将由四个基于证据的 从一般人群的先前研究中得出的组成部分：（1）护士领导的护理协调，（2）护士 - 托管药物方案和依从性支持（3）家庭BP监控，以及（4）电子 医疗记录（EMR）支持工具。这些组件将进一步适应HIV专业诊所 具有关键利益相关者输入的上下文，并使用当前ASCVD预防的混合方法研究中的数据 在三个HIV诊所的护理实践。主要结果将是收缩压和 次要结果将是非HDL胆固醇的变化。第三结局将是变化是 以下级别级联类别中参与者的比例：（1）适当诊断 高血压和高脂血症（2）适当管理； （3）治疗目标（收缩压 <140mmHg和非HDL胆固醇<国家脂质协会靶标）。该研究将具有> 80％的功率 检测6mmHg的下收缩BP和> 90％的功率，以检测15mg/dl较低的非HDL胆固醇 在干预部门与教育控制中。预防护士干预的过程评估将 进行，这将评估忠诚，剂量，招聘，覆盖范围和环境。两个关键的上下文过程 感兴趣的度量将是感知到的ASCVD风险和信任和沟通变化的变化 在PLHIV参与者与其艾滋病毒和非HIV提供者之间。如果被证明有效减少两种血液 压力和胆固醇如发布的，我们的护士主导的干预将产生重大的临床影响 在高风险的PLHIV中，有可能将ASCVD事件减少超过四分之一。这个模型是 作为全国艾滋病毒治疗级联计划的扩展，有可能扩展。