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COVID-19疾病大流行的背景下，社交距离可能会扩大 由于限制与亲人，朋友， 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，并减少参与自我管理和身体 活动艾滋病毒感染者（PLWH）患心血管疾病（CVD）的风险增加， 特别容易受到公共卫生措施造成的压力和社会孤立， 2019冠状病毒病。使用混合方法和以人为本的设计方法，我们已经开发并正在 目前正在进行一项随机对照试验，以护士为主导的干预措施， 用于预防CVD的TTreatment cAscade（EXTRA-CVD）。种族和族裔多样化的参与者 抑制性抗逆转录病毒治疗（共n=300;迄今为止入组了64例）伴高血压和高胆固醇的患者， HIV专科诊所[大学医院、MetroHealth（克利夫兰，OH）和杜克健康（达勒姆，NC）] 以1：1的比例随机分为干预组和教育对照组。作为对NOT-OD-20-757的回应，我们建议 行政补充，以利用EXTRA-CVD平台评估和适应 COVID-19 on CVD Self-Management and Prevention Care in Adults Living with HIV（AAIM-High）.的 拟议活动获得IRB批准，并准备在获得资金后立即开始。在目标1中，我们 将评估COVID-19相关社交距离对艾滋病毒和心血管疾病自我管理的影响 使用经过充分验证的工具，NIH通用数据元素， 和序贯混合方法设计。在目标2中，我们将进行混合第3类实施研究， 评估实施虚拟增强的EXTRA-CVD干预以改善BP控制， PLWH。使用以人为本的设计方法，我们将召集我们的EXTRA-CVD利益相关者设计 团队，以完善干预的虚拟增强功能，例如虚拟依从性支持小组， 心血管病预防专家远程会诊和社区卫生工作者技术 教练我们将招募患有高血压的成人PLWH参与者（n=75），他们接受抑制性ART， 不符合母试验的条件，因为他们没有高胆固醇或因为他们不愿意或 无法参加现场试验。因此，该补充研究组不会潜在地 来自母试验的合格受试者。基于RE-AIM框架的实施成果将 与父母试验受试者相比：覆盖率（同意参与的百分比）、有效性（家庭变化） 收缩压）、采用（家庭BP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， EXTRA-CVD研究的可扩展性，而不影响母试验的完整性或可行性。