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.
- Okeke NL, Webel AR, Bosworth HB, Aifah A, Bloomfield GS, Choi E, Gonzales S, Hale S, Hileman CO, Kidwell V, Muiruri C, Oakes M, Schexnayder J, Smith V, Vedanthan R, Longenecker CT. Rationale and Design of A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention Trial (EXTRA-CVD). (In Press) American Heart Journal.
- 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.