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: 9978088
• 负责人: Hayden B Bosworth
• 金额: $ 94.23万
• 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 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9978088
• 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 Intervention; Preventive care; Preventive therapy; Primary Health Care; Process; Process Measure; Protocols documentation; Provider; Randomized; Registries; Risk; Site; Specialist; Surveys; Testing; Treatment Step; Trust; United States; University Hospitals; Viral; Viral Load result; 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; 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.

艾滋病毒感染者（PLHIV）患动脉粥样硬化性心血管疾病（ASCVD）的风险增加; 然而，采用循证疗法预防ASCVD是次优的。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竞争优先事项，以及信任度低， 与非艾滋病毒初级保健提供者的沟通。该项目提出了一个护士主导的干预措施， 扩大艾滋病毒/艾滋病治疗级联-这是一个广泛采用的框架， 高质量的艾滋病毒护理-预防心血管疾病，特别是改善血压控制， 高脂血症的艾滋病毒感染者接受抗逆转录病毒治疗，抑制了艾滋病毒载量。本研究将 在三个种族和人种多样化的诊所环境中进行[大学医院（克利夫兰，OH）， MetroHealth（Cleveland，OH）和杜克健康（达勒姆，NC）]，广泛代表HIV专业 照顾美国。使用混合方法的临床有效性试验设计，该项目将测试12个月的 在n=300例HIV阳性成人中进行多组分干预对高血压患者进行抑制性ART的疗效 和高脂血症。受试者将以1：1的比例随机分为干预组和教育对照组。控制 参加者将接受一般预防教育。干预措施将包括四个基于证据的 来自普通人群先前研究的组成部分：（1）护士主导的护理协调，（2）护士- 管理药物方案和依从性支持（3）家庭BP监测，以及（4）电子 医疗记录（EMR）支持工具。这些组成部分将进一步调整，以适应艾滋病毒专科诊所 关键利益相关者输入的背景，并使用来自当前ASCVD预防性治疗的混合方法研究的数据 三个艾滋病毒诊所的护理做法。主要结局将是收缩压的变化， 次要结果是非HDL胆固醇的变化。第三个结果将是变化 以下扩展级联类别的参与者比例：（1）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 <140 mmHg和非HDL胆固醇<国家脂质协会目标）。本研究将具有>80%的把握度 检测收缩压降低6 mmHg，检测非HDL胆固醇降低15 mg/dL的把握度>90% 在干预组和教育对照组中。预防护理干预的过程评价将 进行，这将评估保真度，剂量，招募，范围和背景。两个关键的上下文过程 关注的指标将是感知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和非艾滋病毒提供者之间的关系。如果证明有效， 压力和胆固醇的假设，我们的护士领导的干预将有实质性的临床影响 在高风险PLHIV中，可能将ASCVD事件减少四分之一以上。该模型 作为全国艾滋病毒治疗级联倡议的延伸，这一方案可能具有可扩展性。