Nurse-Led Strategy to Improve Blood Pressure and Cholesterol Level Among People With HIV: A Randomized Clinical Trial.
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2024-03
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Abstract
Importance
Despite higher atherosclerotic cardiovascular disease (ASCVD) risk, people with HIV (PWH) experience unique barriers to ASCVD prevention, such as changing models of HIV primary care.Objective
To test whether a multicomponent nurse-led strategy would improve systolic blood pressure (SBP) and non-high-density lipoprotein (HDL) cholesterol level in a diverse population of PWH receiving antiretroviral therapy (ART).Design, setting, and participants
This randomized clinical trial enrolled PWH at 3 academic HIV clinics in the US from September 2019 to January 2022 and conducted follow-up for 12 months until January 2023. Included patients were 18 years or older and had a confirmed HIV diagnosis, an HIV-1 viral load less than 200 copies/mL, and both hypertension and hypercholesterolemia. Participants were stratified by trial site and randomized 1:1 to either the multicomponent EXTRA-CVD (A Nurse-Led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention) intervention group or the control group. Primary analyses were conducted according to the intention-to-treat principle.Intervention
The EXTRA-CVD group received home BP monitoring guidance and BP and cholesterol management from a dedicated prevention nurse at 4 in-person visits (baseline and 4, 8, and 12 months) and frequent telephone check-ins up to every 2 weeks as needed. The control group received general prevention education sessions from the prevention nurse at each of the 4 in-person visits.Main outcomes and measures
Study-measured SBP was the primary outcome, and non-HDL cholesterol level was the secondary outcome. Measurements were taken over 12 months and assessed by linear mixed models. Prespecified moderators tested were sex at birth, baseline ASCVD risk, and trial site.Results
A total of 297 PWH were randomized to the EXTRA-CVD arm (n = 149) or control arm (n = 148). Participants had a median (IQR) age of 59.0 (53.0-65.0) years and included 234 males (78.8%). Baseline mean (SD) SBP was 135.0 (18.8) mm Hg and non-HDL cholesterol level was 139.9 (44.6) mg/dL. At 12 months, participants in the EXTRA-CVD arm had a clinically significant 4.2-mm Hg (95% CI, 0.3-8.2 mm Hg; P = .04) lower SBP and 16.9-mg/dL (95% CI, 8.6-25.2 mg/dL; P < .001) lower non-HDL cholesterol level compared with participants in the control arm. There was a clinically meaningful but not statistically significant difference in SBP effect in females compared with males (11.8-mm Hg greater difference at 4 months, 9.6 mm Hg at 8 months, and 5.9 mm Hg at 12 months; overall joint test P = .06).Conclusions and relevance
Results of this trial indicate that the EXTRA-CVD strategy effectively reduced BP and cholesterol level over 12 months and should inform future implementation of multifaceted ASCVD prevention programs for PWH.Trial registration
ClinicalTrials.gov Identifier: NCT03643705.Type
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Publication Info
Longenecker, Christopher T, Kelley A Jones, Corrilynn O Hileman, Nwora Lance Okeke, Barbara M Gripshover, Angela Aifah, Gerald S Bloomfield, Charles Muiruri, et al. (2024). Nurse-Led Strategy to Improve Blood Pressure and Cholesterol Level Among People With HIV: A Randomized Clinical Trial. JAMA network open, 7(3). p. e2356445. 10.1001/jamanetworkopen.2023.56445 Retrieved from https://hdl.handle.net/10161/31220.
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Scholars@Duke
Nwora Lance Okeke
Gerald Bloomfield
Gerald Bloomfield, MD, MPH, joined the faculty in Medicine and Global Health after completing his Cardiovascular Medicine fellowship training at Duke University Medical Center and Duke Clinical Research Institute. Bloomfield also completed the Duke Global Health Residency/Fellowship Pathway and a Fogarty International Clinical Research Fellowship. He received his medical education, internal medicine residency and Master of Public Health degree from Johns Hopkins University. Bloomfield leads a longstanding research and capacity building program on cardiovascular global health which includes work in under-resourced communities in the US and a number of low- and middle-income country settings.
Charles Muiruri
Dr. Muiruri is a health services researcher, Assistant Professor in the Duke Department of Population Health Sciences, Assistant Research Professor in the Global Health Institute, and Adjunct lecturer at the Kilimanjaro Christian Medical University College, Moshi Tanzania.
Broadly, his research seeks to improve the quality of healthcare and reduce disparities for persons with multiple chronic conditions both in and outside the United States. His current work focuses on prevention of nonAIDS comorbidities among people living with HIV. His current projects funded by NIAID, NHLBI and NIMHD focus on improving the quality of cardiovascular disease prevention and care among people living with HIV in North Carolina and Tanzania.
Areas of Expertise: Mixed methods, Qualitative methods, Applied Econometrics in Health services Research, Preference research, Implementation Science, Global Health, Health Policy
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