# A nurse-led intervention to extend the HIV treatment cascade for cardiovascular disease prevention (EXTRA-CVD)

> **NIH NIH U01** · CASE WESTERN RESERVE UNIVERSITY · 2020 · $187,362

## Abstract

People living with HIV (PLHIV) are at increased risk for atherosclerotic cardiovascular disease (ASCVD);
however, uptake of evidence based therapies to prevent ASCVD is sub-optimal. Reasons for under treatment
may include low perceived risk, competing priorities for HIV specialist providers, and poor trust and
communication with non-HIV primary care providers. This project proposes a nurse-led intervention to
extend the HIV/AIDS treatment cascade—a widely adopted framework developed to improve access to high
quality HIV care—for CVD prevention, specifically to improve control of blood pressure and
hyperlipidemia in PLHIV on antiretroviral therapy who have suppressed HIV viral load. The study will be
conducted in three racially and ethnically diverse clinic contexts [University Hospitals (Cleveland, OH),
MetroHealth (Cleveland, OH) and Duke Health (Durham, NC)] that are broadly representative of HIV specialty
care in the US. Using a mixed-methods clinical effectiveness trial design, this project will test the 12-month
efficacy of a multi-component intervention among n=300 HIV+ adults on suppressive ART with hypertension
and hyperlipidemia. Participants will be randomized 1:1 to intervention vs. education control. Control
participants will receive general prevention education. The intervention will consist of four evidence-based
components derived from prior studies in the general population: (1) nurse-led care coordination, (2) nurse-
managed medication protocols and adherence support (3) home BP monitoring, and (4) electronic
medical records (EMR) support tools. These components will be further adapted to the HIV specialty clinic
context with key stakeholder input and using data from a mixed-methods study of current ASCVD preventive
care practices at the three HIV clinic sites. The primary outcome will be change in systolic blood pressure and
secondary outcome will be change in non-HDL cholesterol. The tertiary outcome will be the change is the
proportion of participants in the following extended cascade categories: (1) appropriately diagnosed with
hypertension and hyperlipidemia (2) appropriately managed; (3) at treatment goal (systolic blood pressure
<140mmHg and non-HDL cholesterol < National Lipid Association targets). The study will have >80% power
to detect a 6mmhg lower systolic BP and >90% power to detect a 15mg/dL lower non-HDL cholesterol
in the intervention arm vs. education control. A process evaluation of the prevention nurse intervention will
be conducted, which will assess fidelity, dose, recruitment, reach, and context. Two key contextual process
measures of interest will be changes in perceived ASCVD risk and changes in trust and communication
between PLHIV participants and their HIV and non-HIV providers. If proven effective to reduce both blood
pressure and cholesterol as postulated, our nurse-led intervention will have substantial clinical impact
among high-risk PLHIV, potentially reducing ASCVD events by more than a quarter. ...

## Key facts

- **NIH application ID:** 10113103
- **Project number:** 3U01HL142099-03S1
- **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:** $187,362
- **Award type:** 3
- **Project period:** 2018-07-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10113103

## Citation

> US National Institutes of Health, RePORTER application 10113103, A nurse-led intervention to extend the HIV treatment cascade for cardiovascular disease prevention (EXTRA-CVD) (3U01HL142099-03S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10113103. Licensed CC0.

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