Protocol paper: Stepped wedge cluster randomized trial translating the ABCS into optimizing cardiovascular care for people living with HIV,☆☆

https://doi.org/10.1016/j.pcad.2020.02.003Get rights and content

Abstract

People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts. The ABCS (aspirin-blood pressure control-cholesterol control-smoking cessation) reduce atherosclerotic (ASCVD) risk in the general population, but little is known regarding strategies for promoting the ABCS among PWH. Guided by the Consolidated Framework for Implementation Research (CFIR), we designed multilevel implementation strategies that target PWH and their clinicians to promote appropriate use of the ABCS based on a 10-year estimated ASCVD risk. Implementation strategies include patient coaching, automated texting, peer phone support, academic detailing and audit and feedback for the patient's clinician. We are evaluating implementation through a stepped wedge cluster randomized trial based on the Reach-Effectiveness-Adoption-Maintenance/Qualitative-Evaluation-for-Systematic-Translation (RE-AIM/QuEST) mixed methods framework that integrates quantitative and qualitative assessments. The primary outcome is change in ASCVD risk. Findings will have important implications regarding strategies for reducing ASCVD risk among PWH.

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:

  • Joseph P. Addabbo Health Center, Queens, NY

  • Morris Heights Health Center, Bronx, NY

  • Brownsville Multi-specialty Practice, Brooklyn, NY

  • Metropolitan Family Health Center and Jersey City Medical Center, Jersey City, NJ

  • Family Health Centers at NYU Langone – Sunset Terrace Health Center, Brooklyn, NY

  • Bluitt-Flowers Health Clinic, Dallas, TX

  • Amelia Court Clinic, Dallas, TX

  • URMC AIDS Center, Rochester, NY

  • Trillium Health, Rochester, NY

References (48)

  • J.V. Baker et al.

    Biomarkers and HIV-associated cardiovascular disease

    Curr Opin HIV AIDS

    (2010)
  • K. Arnett Donna et al.

    2019 ACC/AHA guideline on the primary prevention of cardiovascular disease

    Circulation

    (2019)
  • Centers for Disease Control and Prevention

    Million hearts. NIH

  • A.M. Thompson-Paul et al.

    Cardiovascular disease risk prediction in the HIV Outpatient Study

    Clin Infect Dis

    (2016)
  • M.E. Clement et al.

    Statin utilization and recommendations among HIV-and HCV-infected veterans: a cohort study

    Rev Infect Dis

    (2016)
  • S.G. Kelly et al.

    Statin prescribing practices in the comprehensive care for HIV-infected patients

    J Acquir Immune Defic Syndr

    (2017)
  • S. Suchindran et al.

    Aspirin use for primary and secondary prevention in Human Immunodeficiency Virus (HIV)-infected and HIV-uninfected patients

    Open Forum Infect Dis

    (2014)
  • J. Shuter et al.

    Provider beliefs and practices relating to tobacco use in patients living with HIV/AIDS: a national survey

    AIDS Behav

    (2012)
  • A.K. Monroe et al.

    Control of medical comorbidities in individuals with HIV

    JAIDS

    (2011)
  • L.J. Damschroder et al.

    Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science

    Implement Sci

    (2009)
  • G.M. Curran et al.

    Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact

    Med Care

    (2012)
  • A. Boaz et al.

    Effective implementation of research into practice: an overview of systematic reviews of the health literature

    BMC Res Notes

    (2011)
  • M.A. O’Brien et al.

    Educational outreach visits: effects on professional practice and health care outcomes

    Cochrane Database Syst Rev

    (2007)
  • N. Ivers et al.

    Audit and feedback: effects on professional practice and healthcare outcomes

    Cochrane Database Syst Rev

    (2012)
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    Statement of Conflict of Interest: see page 132.

    ☆☆

    Supported by: NHLBI U01HL142107 and NCATS UL1 TR002001 and NCATS UL1 TR000043.

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