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.

Public Health Relevance

Social distancing measures put in place to combat the SARS-CoV-2 coronavirus and COVID-19 disease pandemic may increase social isolation and impact cardiovascular disease prevention behaviors among people living with HIV (PLWH). Our proposed supplemental study will leverage an ongoing clinical trial of a nurse-led intervention to improve blood pressure and cholesterol care for PLWH to first assess the impact of COVID-19 on HIV and cardiovascular disease self-management. We will then assess the implementation of the intervention with added enhancements to facilitate virtual interactions with patients.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZHL1)
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Shero, Susan
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Case Western Reserve University
Internal Medicine/Medicine
Schools of Medicine
United States
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