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

> **NIH NIH U01** · CASE WESTERN RESERVE UNIVERSITY · 2020 · $446,517

## Abstract

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 ...

## Key facts

- **NIH application ID:** 10164926
- **Project number:** 3U01HL142099-03S2
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** Hayden B Bosworth
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $446,517
- **Award type:** 3
- **Project period:** 2018-07-01 → 2021-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10164926

## Citation

> US National Institutes of Health, RePORTER application 10164926, Assess and Adapt to the Impact of COVID-19 on CVD Self Management  and Prevention Care  in Adults Living with HIV (AAIM-High) (3U01HL142099-03S2). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10164926. Licensed CC0.

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