The EXTRA-CVD Study

EXTRA-CVD Logo

A Nurse-Led Intervention to Extend the HIV Treatment Cascade for cardiovascular disease prevention (EXTRA-CVD)

Years: 2018-2022

Background

People living with HIV (PLWHIV or PLWH) are at high risk for developing cardiovascular disease (CVD). Although HIV-specific factors play a role in CVD, traditional risk factors--including hypertension and hyperlipidemia--account for the vast majority of risk. The EXTRA-CVD Study tests a nurse-led intervention to improve control of hypertension and hyperlipidemia in PLWHIV.

The intervention will consist of four evidenced-based components:

  1. nurse-led care coordination,
  2. nurse-managed medication protocols and adherence support,
  3. home blood pressure monitoring, and
  4. electronic medical records support tools.

This study aims to:

  • Conduct a baseline assessment of atherosclerotic cardiovascular disease (ASCVD) preventative care and perceptions of ASCVD risk in the HIV specialty clinic environment;
  • Evaluate the 12-month efficacy of the EXTRA-CVD intervention to improve BP and cholesterol control in PLWHIV; and
  • Conduct a process evaluation of the EXTRA-CVD intervention.

Research Design

EXTRA-CVD is a mixed-methods clinical effectiveness trial design using an intent to treat approach. For the trial component of the study, 300 participants will be randomized 1:1 to the nurse-led intervention versus an educational control. The primary outcome will be the change in systolic blood pressure and the secondary outcome will be change in non-HDL cholesterol. Participants will complete measures at baseline, 4, 8, and 12 months. A mixed-methods process evaluation will be used to monitor program implementation and better understand the relationship between the intervention components and health outcomes. This study was registered at ClinicalTrials.gov #NCT03643705

Results

Data collection for the baseline assessment is underway. The EXTRA-CVD intervention human-centered design process.

Research Publications

Media

$3 million grant extends HIV intervention to prevent heart disease

Resources

Participant Website

Research Team

Principal Co-Investigators

  • Allison Webel, PhD, RN, FAAN, Frances Payne Bolton School of Nursing, Case Western Reserve University
  • Christopher Longenecker, MD, University Hospitals Harrington Heart & Vascular Institute
  • Hayden Bosworth, PhD, Department of Population Health Sciences, Duke University

Co-Investigators

Support

This study is funded by the National Heart, Lung, and Blood Institute (National Institutes of Health), U01HL142099-01.

Logos for the EXTRA-CVD Research study supporters/partners