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