Hypertension Clinical Trial
Official title:
Epidemiology of Atherosclerosis Among Older-Age People in Southwestern Uganda
Longitudinal cohort study of older-aged people living with HIV infection in southwestern Uganda and age and gender-matched HIV uninfected controls with the primary aim of measuring the epidemiology of cardiovascular and pulmonary disease in this study setting, and particularly the contribution of HIV infection to it.
This study recruits people living with HIV/AIDS (PLWH) aged 40 and older; and an
HIV-uninfected age and gender-matched, community-based comparison group in the HIV clinic
catchment area.
Study investigators will collect sociodemographic, clinical, immune activation, systemic
inflammation, plasma and stool microbiome, and clinical pulmonary and cardiovascular disease
measures. Our outcomes of interest are measures of carotid atherosclerosis, including carotid
intima media thickness and presence of plaque, prior ischemic heart disease (as measured by
electrocardiograms), peripheral arterial disease (as measured by ankle-branchial index), and
lung function as measured by pulmonary function testing. Our exposures of interest are
traditional cardiovascular disease risk factors (e.g. age, gender, family history of
cardiovascular disease, smoking history, diet, activity, body mass index, prevalence of
diabetes, and prevalence of hypertension) and HIV-related cardiovascular risk factors (e.g.
nadir CD4 count, ART duration and regimen, gut and plasma microbiome composition, and markers
of both immune activation and systemic inflammation).
Investigators will collect this data to accomplish the following aims:
Aim 1: Compare the prevalence of atherosclerosis, measured by cIMT, ankle-brachial index, and
presence of q-waves on electrocardiogram, in PLWH taking ART aged 40 and older and age and
gender-matched, population-based HIV-uninfected controls. This study aims to be among the
first to capture high-quality measures of atherosclerotic disease among a population of PLWH
in sub-Saharan Africa. The study aims to test the hypothesis that older-age Ugandans on ART
will have thicker carotid intima media, higher prevalence of peripheral arterial disease, and
higher prevalence of pathologic q-waves on electrocardiogram than age and gender-matched,
HIV-uninfected controls.
Aim 2: Evaluate correlates of atherosclerosis in older-age PLWH on ART, including both
traditional (age, gender, smoking, diabetes and hypertension prevalence) and HIV-related risk
factors (immune activation, systemic inflammation, and stool and plasma microbiome
composition). The study will leverage a collaboration with the Ragon Institute to perform
immunologic and molecular testing for microbial translocation and markers of immune
activation and systemic inflammation (e.g. soluble CD163, C-reactive protein, IL-6, CD8+
T-lymphocyte activation).
Aim 3: Compare the progression of atherosclerosis in PLWH versus HIV-uninfected individuals
over five years of observation time. The study aims to test the hypothesis that the rate of
change in carotid intima media thickness will be faster in among PLWH over 45 on ART than age
and gender-matched HIV-uninfected controls, and that rates of change in carotid intima media
thickness among the HIV-infected cohort will be associated with markers of microbial
translocation, immune activation, and systemic inflammation.
Aim 4: Compare the prevalence and incidence of abnormal pulmonary function (FEV1, FVC,
FEV1/FVC) in PLWH on ART and age- and gender-matched, population-based HIV-uninfected
controls, utilizing handheld spirometry with bronchodilator challenge. The study aims to test
the hypothesis that pulmonary function is worse and COPD is more common among people living
with HIV/AIDS than age- and gender-match HIV-uninfected controls.
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