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Author Notes:

C. Christina Mehta, christina.mehta@emory.edu

The authors gratefully acknowledge the contributions of the study participants and dedication of the staff at the Emory MWCCS site.

Subjects:

Research Funding:

Supported by the National Institutes of Health (NIH, nih.gov) under Award Numbers U54AG062334, U01HL146241, P30AI050409.

M.N.W. and I.O. are also supported in part by NIH grants R01AR070091 and R01AR068157.

M.N. W. is also supported in part by award BX000105 from the U.S. Department of Veterans Affairs.

C.A.M. is also supported in part by NIH award K23 HL152903.

C.D.L. is also supported in part by NIH award K23 AI124913.

L. F. C. is also supported by the National Center for Advancing Translational Sciences (NCATS) (NIH award numbers UL1TR002378 and KL2TL1TR002381). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The funders have not had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. There was no additional external funding received for this study.

Keywords:

  • Science & Technology
  • Multidisciplinary Sciences
  • Science & Technology - Other Topics
  • HUMAN-IMMUNODEFICIENCY-VIRUS
  • WOMENS INTERAGENCY HIV
  • INFECTED PATIENTS
  • MINERAL DENSITY
  • ANTIRETROVIRAL THERAPY
  • MICROBIAL TRANSLOCATION
  • MYOCARDIAL-INFARCTION
  • CARDIOVASCULAR RISK
  • INFLAMMATION
  • POPULATION

Bone, Brain, Heart study protocol: A resilient nested, tripartite prospective cohort study of the role of estrogen depletion on HIV pathology

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Journal Title:

PLOS ONE

Volume:

Volume 17, Number 8

Publisher:

, Pages e0272608-e0272608

Type of Work:

Article | Final Publisher PDF

Abstract:

Purpose We describe the rationale for and design of an innovative, nested, tripartite prospective observational cohort study examining whether relative estrogen insufficiency-induced inflammation amplifies HIV-induced inflammation to cause end organ damage and worsen age-related co-morbidities affecting the neuro-hypothalamic-pituitary-adrenal axis (Brain), skeletal (Bone), and cardiovascular (Heart/vessels) organ systems (BBH Study). Methods The BBH parent study is the Multicenter AIDS Cohort/Women's Interagency HIV Study Combined Cohort Study (MWCCS) with participants drawn from the Atlanta MWCCS site. BBH will enroll a single cohort of n = 120 women living with HIV and n = 60 HIV-negative women, equally distributed by menopausal status. The innovative multipart nested study design of BBH, which draws on data collected by the parent study, efficiently leverages resources for maximum research impact and requires extensive oversight and management in addition to careful implementation. The presence of strong infrastructure minimized BBH study disruptions due to changes in the parent study and the COVID-19 pandemic. Conclusion BBH is poised to provide insight into sex and HIV associations with the neuro-hypothalamicpituitary-adrenal axis, skeletal, and cardiovascular systems despite several major, unexpected challenges.

Copyright information:

© 2022 Christina Mehta et al

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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