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

• Published in: PloS one 2022-08, Vol.17 (8), p.e0272608-e0272608
• Main Authors: Mehta, C Christina, Hagen, Kimberly S, Rubtsova, Anna A, Lahiri, Cecile D, Michopoulos, Vasiliki, Moran, Caitlin A, Haddad, Lisa B, Titanji, Kehmia, Collins, Lauren F, Quyyumi, Arshed A, Neigh, Gretchen, Shaw, Leslee J, Weitzmann, M Neale, Waller, Lance, Ofotokun, Ighovwerha
• Format: Article
• Language: English
• Subjects: Age; Antigens; Biology and Life Sciences; Blood vessels; Brain damage; Brain research; Cohort analysis; Cohort Studies; Complications and side effects; COVID-19; Depletion; Diagnosis; Estrogen; Estrogens; Female; Fractures; Gender differences; Health aspects; Heart; HIV; HIV (Viruses); HIV Infections - complications; HIV Infections - epidemiology; Human immunodeficiency virus; Humans; Hypothalamic-pituitary-adrenal axis; Hypothalamo-Hypophyseal System; Hypothalamus; Immune system; Infections; Infectious diseases; Inflammation; Inflammation - complications; Medicine and Health Sciences; Menopause; Morbidity; Multicenter Studies as Topic; Observational Studies as Topic; Pandemics; Pathogenesis; Pathogens; Pathology; Pituitary; Pituitary-Adrenal System; Prospective Studies; Public health; Research and Analysis Methods; Sexually transmitted diseases; STD; Stroke; Study Protocol; Trauma; Tumor necrosis factor-TNF; Womens health
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0272608

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). 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. BBH is poised to provide insight into sex and HIV associations with the neuro-hypothalamic-pituitary-adrenal axis, skeletal, and cardiovascular systems despite several major, unexpected challenges.