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

Social distancing in the context of the SARS-CoV-2 coronavirus and COVID-19 disease pandemic may amplifyisolation 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 physicalactivity. People living with HIV (PLWH) are at increased risk for cardiovascular disease (CVD) and areparticularly vulnerable to the stress and social isolation caused by the public health measures to combatCOVID-19. Using mixed-methods and a human-centered design approach, we have developed and arecurrently testing in a randomized controlled trial a nurse-led intervention to EXtend the HIV/AIDSTReatment cAscade for CVD prevention (EXTRA-CVD). Racially and ethnically diverse participants onsuppressive antiretroviral therapy (n=300 total; 64 enrolled to date) with high BP AND high cholesterol from 3HIV-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 thisadministrative supplement to leverage the EXTRA-CVD platform to Assess and Adapt to the Impact ofCOVID-19 on CVD Self-Management and Prevention Care in Adults Living with HIV (AAIM-High). Theproposed activities are IRB approved and ready to begin immediately if funded. In a formative Aim 1, wewill assess the impact of COVID-19 related social distancing on HIV and CVD self-managementbehaviors among participants in EXTRA-CVD using well-validated instruments, NIH common data elementsand a sequential mixed-methods design. In Aim 2, we will conduct a hybrid type 3 implementation study toevaluate the implementation of a virtually enhanced EXTRA-CVD intervention to improve BP control inPLWH. Using a human-centered design approach, we will convene our EXTRA-CVD stakeholder DesignTeam, to refine virtual enhancements to the intervention, such as virtual adherence support groups,cardiovascular prevention specialist remote consultation, and community health worker technologycoaches. We will enroll adult PLWH participants (n=75) on suppressive ART with high BP whom are otherwiseineligible for the parent trial because they do not also have high cholesterol or because they are unwilling orunable to participate in the in-person trial. Thus, this supplemental study arm will not poach potentiallyeligible participants from the parent trial. Implementation outcomes based on a RE-AIM framework will becompared to parent trial participants: reach (% agreeing to participate), effectiveness (change in homesystolic BP), adoption (frequency of home BP use), implementation (qualitative assessment offeasibility/acceptability), and maintenance (qualitative). This supplement will increase the impact andscalability of the EXTRA-CVD study without compromising the integrity or feasibility of the parent trial.