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.

艾滋病毒携带者(PLHIV)患动脉粥样硬化性心血管疾病(ASCVD)的风险增加； 然而，采用循证治疗来预防ASCVD并不是最理想的。治疗不足的原因 可能包括低感知风险，艾滋病毒专家提供者的优先事项相互竞争，以及较差的信任和 与非艾滋病毒初级保健提供者的沟通。该项目提出了一种由护士主导的干预措施 扩大艾滋病毒/艾滋病治疗级联--这是一个被广泛采用的框架，旨在改善获取艾滋病毒/艾滋病的机会 优质艾滋病毒护理-预防心血管疾病，特别是改善血压控制和 接受抗逆转录病毒治疗的PLHIV患者出现高脂血症，这些患者抑制了HIV病毒载量。这项研究将是 在三个种族和民族不同的临床环境中进行[大学医院(克利夫兰，俄亥俄州)， MetroHealth(俄亥俄州克利夫兰)和Duke Health(北卡罗来纳州达勒姆)]，它们是艾滋病毒专业的广泛代表 在美国的关爱。使用混合方法的临床有效性试验设计，该项目将测试12个月 多组分干预对300例HIV+成人高血压患者抑制性ART的疗效 和高脂血症。参与者将被随机分为干预和教育控制两组。控制 参加者将接受一般预防教育。干预措施将包括四个以证据为基础的 来自普通人群先前研究的组成部分：(1)护士领导的护理协调，(2)护士- 受管用药方案和依从性支持(3)家庭血压监测，以及(4)电子 病历(EMR)支持工具。这些组成部分将进一步适用于艾滋病毒专科诊所 背景与关键利益相关者的输入，并使用当前ASCVD预防的混合方法研究的数据 三个艾滋病毒诊所地点的护理做法。主要结果将是收缩压和 次要结果将是非高密度脂蛋白胆固醇的变化。第三种结果将是变化是 下列扩展级联类别的参与者比例：(1)被适当诊断为 高血压和高脂血症(2)适当管理；(3)达到治疗目标(收缩压 &lt；140毫米汞柱和非高密度脂蛋白胆固醇&lt；国家脂质协会目标)。这项研究将拥有80%的权力 检测6 mm Hg较低的收缩压和90%的功率以检测较低15 mg/dL的非高密度脂蛋白胆固醇 在干预手臂和教育控制之间。预防护士干预的过程评价 将对忠诚度、剂量、招募、覆盖范围和背景进行评估。两个关键的情景流程 关注的指标将是感知的ASCVD风险的变化以及信任和沟通的变化 艾滋病毒感染者与其艾滋病毒提供者和非艾滋病毒提供者之间的联系。如果被证明有效的话，可以减少两种血液 如假设的那样，我们的护士主导的干预措施将对临床产生重大影响 在高危PLHIV中，ASCVD事件可能减少四分之一以上。这个型号是 作为全国艾滋病毒治疗级联倡议的延伸，有可能扩大规模。