A Nurse-Led Intervention to Extend the HIV Treatment Cascade for cardiovascular disease prevention (EXTRA-CVD)
Peopleliving with HIV (PLWHIV) 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:
- nurse-led care coordination,
- nurse-managed medication protocols and adherence support,
- home blood pressure monitoring, and
- 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.
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 and 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
Data collection for the baseline assessment is underway. The EXTRA-CVD intervention human-centered design process is projected to begin in Spring 2019.
- Oakes MM, Webel AR, Bosworth HB, Smith V, Okeke NL, Muiruri C, Longenecker CT. Poster: A Nurse-led Intervention to Extend the HIV Treatment Cascade For Cardiovascular Disease Prevention: Study Design for the EXTRA-CVD Trial. 11th Annual Academy Health Conference on the Science of Dissemination and Implementation. Washington, DC; December 2018.
- Webel, A.R., Okeke, L., & Longenecker, C.T. Promoting cardiovascular health in people living with HIV: Best across resource settings for patients, community health workers, and health care providers. 22nd Annual International AIDS Conference. July 26, 2018. Amsterdam, Netherlands.
- 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
- Carrilynn Hileman, MD, MetroHealth Medical Center
- Rajesh Vedanthan, MD, MPH, New York University
- Gerald Bloomfield, MD, MPH, Duke University School of Medicine
- Lance Okeke, MD, MPH, Duke University School of Medicine
- Valerie Smith, DrPH, Duke University School of Medicine
This study is funded by the National Heart, Lung, and Blood Institute (National Institutes of Health), U01HL142099-01.