Assess and Adapt to the Impact of COVID-19 on CVD Self Management and Prevention Care in Adults Living with HIV (AAIM-High)

评估和适应 COVID-19 对成人 HIV 感染者 CVD 自我管理和预防护理的影响 (AAIM-High)

• 批准号: 10164926
• 负责人: Hayden B Bosworth
• 金额: $ 44.65万
• 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 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10164926
• 关键词: 2019-nCoV; AIDS/HIV problem; Adherence; Administrative Supplement; Adoption; Adult; Age; Aging; Behavior; Blood Pressure; Blood Pressure Monitors; COVID-19; COVID-19 pandemic; Cardiovascular Diseases; Cardiovascular system; Caring; Cholesterol; Clinic; Clinical Trials; Common Data Element; Communities; Community Health Aides; Computerized Medical Record; Coronavirus; Data; Eating; Education; Effectiveness; Enrollment; Family member; Frequencies; Friends; Funding; Goals; HIV; HIV risk; Health; Health Personnel; Health system; Home Blood Pressure Monitoring; Home environment; Human; Hybrids; Hypertension; Individual; Institutional Review Boards; Intervention; Loneliness; Maintenance; Measures; Medical Care Team; Mental Depression; Methods; Modeling; Morbidity - disease rate; Nurses; Outcome; Parents; Participant; Patients; Persons; Pharmaceutical Preparations; Physical activity; Predisposition; Prevention; Preventive Intervention; Procedures; Protocols documentation; Public Health; Randomized; Randomized Controlled Trials; Remote Consultation; Resources; Risk; Risk Factors; Self Management; Social Distance; Social Impacts; Social Interaction; Social isolation; Social support; Source; Specialist; Stress; Support Groups; Technology; Telephone; Testing; United States National Institutes of Health; University Hospitals; Videoconferences; Vulnerable Populations; antiretroviral therapy; arm; base; blood pressure regulation; cardiovascular disorder prevention; cardiovascular disorder risk; cardiovascular risk factor; care coordination; cholesterol control; cigarette smoking; combat; coronavirus disease; data format; design; effectiveness clinical trial; eligible participant; ethnic diversity; good diet; health care delivery; high risk; improved; inattention; instrument; loved ones; medical specialties; meetings; member; mortality; nursing intervention; pandemic disease; prevention service; racial diversity; response; sex; social; social stigma; support tools; therapy design; virtual

Social distancing in the context of the SARS-CoV-2 coronavirus and COVID-19 disease pandemic may amplify isolation and loneliness due to the requirement to limit in-person interactions with loved ones, friends, community members, healthcare providers, etc. Social isolation increases susceptibility to illness, stress, hypertension, depression, and mortality and decreases engagement in self-management and physical activity. People living with HIV (PLWH) are at increased risk for cardiovascular disease (CVD) and are particularly vulnerable to the stress and social isolation caused by the public health measures to combat COVID-19. Using mixed-methods and a human-centered design approach, we have developed and are currently testing in a randomized controlled trial a nurse-led intervention to EXtend the HIV/AIDS TReatment cAscade for CVD prevention (EXTRA-CVD). Racially and ethnically diverse participants on suppressive antiretroviral therapy (n=300 total; 64 enrolled to date) with high BP AND high cholesterol from 3 HIV-specialty clinics [University Hospitals, MetroHealth (both Cleveland, OH) and Duke Health (Durham, NC)] are randomized 1:1 to intervention vs. education control. In response to NOT-OD-20-757, we propose this administrative supplement to leverage the EXTRA-CVD platform to Assess and Adapt to the Impact of COVID-19 on CVD Self-Management and Prevention Care in Adults Living with HIV (AAIM-High). The proposed activities are IRB approved and ready to begin immediately if funded. In a formative Aim 1, we will assess the impact of COVID-19 related social distancing on HIV and CVD self-management behaviors among participants in EXTRA-CVD using well-validated instruments, NIH common data elements and a sequential mixed-methods design. In Aim 2, we will conduct a hybrid type 3 implementation study to evaluate the implementation of a virtually enhanced EXTRA-CVD intervention to improve BP control in PLWH. Using a human-centered design approach, we will convene our EXTRA-CVD stakeholder Design Team, to refine virtual enhancements to the intervention, such as virtual adherence support groups, cardiovascular prevention specialist remote consultation, and community health worker technology coaches. We will enroll adult PLWH participants (n=75) on suppressive ART with high BP whom are otherwise ineligible for the parent trial because they do not also have high cholesterol or because they are unwilling or unable to participate in the in-person trial. Thus, this supplemental study arm will not poach potentially eligible participants from the parent trial. Implementation outcomes based on a RE-AIM framework will be compared to parent trial participants: reach (% agreeing to participate), effectiveness (change in home systolic BP), adoption (frequency of home BP use), implementation (qualitative assessment of feasibility/acceptability), and maintenance (qualitative). This supplement will increase the impact and scalability of the EXTRA-CVD study without compromising the integrity or feasibility of the parent trial.

在SARS-CoV-2冠状病毒和新冠肺炎大流行背景下的社会距离可能会放大 由于要求限制与亲人、朋友、 社区成员、医疗保健提供者等。社会孤立增加了对疾病、压力、 高血压、抑郁和死亡率，减少自我管理和体力活动 活动。艾滋病毒携带者(PLWH)患心血管疾病(CVD)的风险增加， 特别容易受到压力和社会孤立的公共卫生措施的打击 新冠肺炎。使用混合方法和以人为中心的设计方法，我们已经开发并正在 目前正在一项随机对照试验中测试护士主导的干预措施，以扩大艾滋病毒/艾滋病的范围 预防心血管疾病的级联治疗(Extra-CVD)。不同种族和民族的参与者在 高血压和高胆固醇的抑制性抗逆转录病毒治疗(共300例；来自3个国家) 艾滋病毒专科诊所[大学医院、MetroHealth(俄亥俄州克利夫兰)和Duke Health(达勒姆，北卡罗来纳州)] 以1：1随机分为干预和教育对照两组。针对NOT-OD-20-757，我们提出如下建议 行政补充，以利用额外的CVD平台评估和适应 新冠肺炎关于成人艾滋病毒携带者的心血管疾病自我管理和预防护理(AAIM-High)。这个 建议的活动得到了IRB的批准，并准备好在获得资金后立即开始。在形成性目标1中，我们 将评估与新冠肺炎相关的社交距离对艾滋病毒和心血管疾病自我管理的影响 使用经过良好验证的工具、NIH公共数据元素在Extra-CVD参与者中的行为 和序贯混合方法设计。在目标2中，我们将进行混合类型3实施研究，以 评估实际上增强的心血管疾病外干预措施的实施情况，以改善对 PLWH。使用以人为中心的设计方法，我们将召集我们的额外CVD利益相关者设计 团队，以完善干预的虚拟增强，例如虚拟遵守支持小组， 心血管预防专家远程会诊和社区卫生工作者技术 教练。我们将招募成年的PLWH参与者(n=75)，接受高血压患者的抑制性ART治疗，但他们的血压不同 没有资格参加父母试验，因为他们没有高胆固醇，或者因为他们不愿意或 无法参加面对面的审判。因此，这一补充研究部门将不会潜在地挖走 家长试验的合格参与者。基于RE-AIM框架的实施成果将是 与父母试验参与者相比：REACH(同意参加的百分比)，有效性(在家中改变 收缩压)、采用(家庭血压使用频率)、实施(定性评估 可行性/可接受性)和维护(定性)。这一补充将增加影响和 在不影响父母试验的完整性或可行性的情况下，额外的心血管疾病研究的可扩展性。