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.

SARS-CoV-2 冠状病毒和 COVID-19 疾病大流行背景下的社会疏远可能会加剧 由于需要限制与亲人、朋友的面对面互动而感到孤立和孤独， 社区成员、医疗保健提供者等。社会隔离增加了对疾病、压力、 高血压、抑郁症和死亡率，并降低自我管理和身体健康的参与度 活动。艾滋病毒感染者 (PLWH) 患心血管疾病 (CVD) 的风险增加，并且 特别容易受到公共卫生措施造成的压力和社会孤立的影响 新冠肺炎。使用混合方法和以人为本的设计方法，我们开发并正在 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延长艾滋病毒/艾滋病的传播范围 CVD 预防治疗级联 (EXTRA-CVD)。不同种族和民族的参与者 患有高血压和高胆固醇的抑制性抗逆转录病毒治疗（总共 300 例；迄今为止已登记 64 例）患有 3 岁以上的高血压和高胆固醇 HIV 专科诊所 [大学医院、MetroHealth（俄亥俄州克利夫兰）和杜克健康中心（北卡罗来纳州达勒姆）] 以 1:1 的比例随机分为干预组和教育控制组。为了回应 NOT-OD-20-757，我们建议这样做 行政补充，利用 EXTRA-CVD 平台评估和适应影响 COVID-19 对成人 HIV 感染者 CVD 自我管理和预防护理的影响 (AAIM-High)。这 拟议的活动已获得 IRB 批准，一旦获得资助，即可立即开始。在形成性目标 1 中，我们 将评估与 COVID-19 相关的社交距离对 HIV 和 CVD 自我管理的影响 使用经过充分验证的仪器、NIH 通用数据元素的 EXTRA-CVD 参与者的行为 和顺序混合方法设计。在目标 2 中，我们将进行混合类型 3 实施研究 评估实际上增强的 EXTRA-CVD 干预的实施情况，以改善血压控制 艾滋病病毒感染者。采用以人为本的设计方法，我们将召开 EXTRA-CVD 利益相关者设计会议 团队，完善干预措施的虚拟增强功能，例如虚拟依从性支持小组， 心血管预防专家远程会诊、社区卫生工作者技术 教练。我们将招募患有高血压的成年 PLWH 参与者 (n=75) 接受抑制性 ART 没有资格参加家长试验，因为他们没有高胆固醇，或者因为他们不愿意或 无法参加现场审判。因此，这个补充研究部门不会潜在地偷猎 来自家长试验的合格参与者。基于 RE-AIM 框架的实施成果将是 与家长试验参与者相比：达到（同意参与的百分比）、有效性（家庭变化） 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）。该补充将增加影响力并 EXTRA-CVD 研究的可扩展性，而不影响母试验的完整性或可行性。