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Randomized Controlled Trial
. 2024 Mar 4;7(3):e2356445.
doi: 10.1001/jamanetworkopen.2023.56445.

Nurse-Led Strategy to Improve Blood Pressure and Cholesterol Level Among People With HIV: A Randomized Clinical Trial

Christopher T Longenecker  1 , Kelley A Jones  2 , Corrilynn O Hileman  3   4 , Nwora Lance Okeke  2 , Barbara M Gripshover  4   5 , Angela Aifah  6 , Gerald S Bloomfield  2 , Charles Muiruri  2 , Valerie A Smith  2   7 , Rajesh Vedanthan  6 , Allison R Webel  8 , Hayden B Bosworth  2   7
Affiliations
Randomized Controlled Trial

Nurse-Led Strategy to Improve Blood Pressure and Cholesterol Level Among People With HIV: A Randomized Clinical Trial

Christopher T Longenecker et al. JAMA Netw Open. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Longenecker reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study and personal fees from Theratechnologies outside the submitted work. Dr Jones reported receiving grants from the National Heart, Lung, and Blood Institute (NHLBI) of the NIH during the conduct of the study. Dr Hileman reported receiving personal fees and grants from Gilead Sciences and personal fees from Theratechnologies outside the submitted work. Dr Okeke reported receiving personal fees from Gilead Sciences outside the submitted work. Dr Gripshover reported receiving grants from the NHLBI of the NIH during the conduct of the study. Dr Smith reported receiving grants from the NIH during the conduct of the study. Dr Vedanthan reported receiving grants from the NIH during the conduct of the study. Dr Webel reported receiving grants from the NIH, personal fees from the Association of Nurses in AIDS Care outside the submitted work, and grants from the American Heart Association during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow Diagram of Study Participants
Not completed indicates that no data were collected because the visit was missed entirely. Some participants missed a visit but subsequently came to future visits. Therefore, the total number of participants included in the analyses at each time point was equal to the total number of prior withdrawals and deaths plus the total number of “not completed” for that time point. EHR indicates electronic health record.
Figure 2.
Figure 2.. Model-Estimated Systolic Blood Pressure (SBP) and Non–High-Density Lipoprotein (HDL) Cholesterol and Associated 95% CIs of the Effects of the Intervention vs Control
Error bars represent 95% CIs.
Figure 3.
Figure 3.. Intervention Effects on Systolic Blood Pressure (SBP) and Non–High-Density Lipoprotein (HDL) Cholesterol by Sex
Error bars represent 95% CIs.
See this image and copyright information in PMC

References

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