Protocol paper: Stepped wedge cluster randomized trial translating the ABCS into optimizing cardiovascular care for people living with HIV☆,☆☆
Section snippets
Background
People living with HIV (PWH) are living longer lives now because of effective antiretroviral therapy (ART).1 However, atherosclerotic (AS) cardiovascular disease (CVD, ASCVD) is more common among PWH than in the general population even when controlling for traditional CVD risk factors, resulting in significant ASCVD morbidity and mortality.2 Evidence shows associations between HIV and inflammatory and coagulation markers, including interleukin (IL-6), C-reactive protein (CRP) and D-dimer.2
Methods/design
ABCS for HIV involves a multicomponent implementation strategy for promoting uptake of the ABCS by targeting PWH based on ASCVD risk and their HIV clinicians. The unit of randomization is the practice and the primary outcome is ASCVD risk measured at the patient level. We will roll out implementation using a stepped wedge cluster randomized trial design in which the implementation strategies are sequentially rolled out to participating practices, clinicians and patients in three steps separated
Discussion
The ABCS for HIV protocol will test an evidence-informed, implementation strategy for primary prevention of ASCVD in PWH cared for in HIV practices. Findings have important clinical implications for the reduction of CVD morbidity and mortality in this at risk population. The ABCS are the framework by which the Million Hearts® 2022 national initiative, co-led by the CDC and the Centers for Medicare & Medicaid Services (CMS), will attempt to prevent one million heart attacks and strokes within
Conclusions/implications of research
Primary prevention targeting specific modifiable risks for cardiovascular disease has the most impact in decreasing ASCVD morbidity and mortality. PWH are at elevated CVD risk despite effective use of ART. Our proposal is innovative in its focus on identifying effective implementation strategies for promoting the ABCS among PWH at appreciable risk. Findings have implications for addressing this emerging ASCVD epidemic among PWH.
Statement of conflict of interest
None of the authors have any conflicts of interests with regard to this publication.
Acknowledgements
We acknowledge our participating sites:
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Joseph P. Addabbo Health Center, Queens, NY
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Morris Heights Health Center, Bronx, NY
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Brownsville Multi-specialty Practice, Brooklyn, NY
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Metropolitan Family Health Center and Jersey City Medical Center, Jersey City, NJ
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Family Health Centers at NYU Langone – Sunset Terrace Health Center, Brooklyn, NY
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Bluitt-Flowers Health Clinic, Dallas, TX
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Amelia Court Clinic, Dallas, TX
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URMC AIDS Center, Rochester, NY
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Trillium Health, Rochester, NY
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Statement of Conflict of Interest: see page 132.
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Supported by: NHLBI U01HL142107 and NCATS UL1 TR002001 and NCATS UL1 TR000043.