Ugandan Non-Communicable Diseases and Aging Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2018-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Examining HIV Treatment Adherence During Early Disease

NCT02419066

Medication Adherence HIV

COMPLETED

Determining Bacterial Communities in the Lungs of HIV-infected Individuals With COPD in Uganda.

NCT04070248

COPD HIV/AIDS

UNKNOWN

Airway Microbiome and Th17-mediated Inflammation in COPD Among HIV-infected Individuals in a Rural Ugandan Cohort

NCT05223114

COPD HIV Infections Respiratory Disease

COMPLETED

International HIV Antiretroviral Adherence, Resistance and Survival

NCT01596322

HIV/AIDS

COMPLETED

Integrated Hypertension and HIV Care Cascades in Uganda

NCT03605043

Hypertension HIV

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Cardiovascular Disease Chronic Obstructive Pulmonary Disease Atherosclerosis Hypertension Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HIV infected

HIV infected sub-group

This is an observational study only

Intervention Type OTHER

Observational study only

HIV uninfected

HIV uninfected sub-group, age and gender matched to the HIV-infected group

This is an observational study only

Intervention Type OTHER

Observational study only

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

This is an observational study only

Observational study only

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* HIV infected
* Age \> 40 years old at enrollment
* Minimum 2 years of antiretroviral therapy

* Living in catchment area of Mbarara Regional Referral Hospital (greater Mbarara)
* Age \> 40 years old
* Age and gender matched to a participant in group 1