HIVUGANDACNCT02445079
Ugandan Non-Communicable Diseases and Aging Cohort
An observational study of HIV and Cardiovascular Disease, run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Cardiovascular Disease, Chronic Obstructive Pulmonary Disease
- What is being tested?
- This is an observational study only
- How many people
- 309 participants
- Where
- 1 siteUganda
- Study dates
- Dec 2013to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study recruits two sub-groups of participants: Study Group 1: -HIV infected persons aged 40 and older, in care at the Immune Suppression Syndrome HIV Clinic at Mbarara Regional Referral Hospital Study Group 2: -Community-based, HIV uninfected persons recruited from the catchment area of the Mbarara Regional Referral Hospital (greater Mbarara), and age and gender-matched to Group 1 participants
Group 1 Inclusion Criteria:
- HIV infected
- Age > 40 years old at enrollment
- Minimum 2 years of antiretroviral therapy
Group 1 Exclusion Criteria:
- Decline informed consent
Group 2 Inclusion Criteria:
- 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
Group 2 Exclusion Criteria:
- HIV infection (tested annually as part of study procedures)
- Decline informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- HIV, Cardiovascular Disease, Chronic Obstructive Pulmonary Disease, Atherosclerosis, Hypertension, Diabetes Mellitus
- Being tested
- This is an observational study only
- Medical subject headings
- Cardiovascular Diseases, Pulmonary Disease, Chronic Obstructive, Atherosclerosis, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study onlyOther
Observational study only
| Study group | Role | What they receive |
|---|---|---|
| HIV infected | HIV infected sub-group Receives: Other: This is an observational study only | |
| HIV uninfected | HIV uninfected sub-group, age and gender matched to the HIV-infected group Receives: Other: This is an observational study only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline prevalence and incident change in carotid intima media thickness
Measured by carotid ultrasonography
Measured: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)
Secondary outcomes (4)
Baseline prevalence and incident change in carotid plaque
Measured by carotid ultrasonography
Measured: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)
Baseline prevalence and incident change in ischemic heart disease
Measured by electrocardiography
Measured: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)
Baseline prevalence and incident change in peripheral arterial disease
Measured by ankle branchial index
Measured: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)
Baseline prevalence and incident change in chronic obstructive pulmonary disease
Measured by pulmonary function testing
Measured: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startDec 2013
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology, University of California, San Francisco, Ragon Institute of MGH, MIT and Harvard, National Institutes of Health (NIH), Harvard University
- Responsible party
- Principal investigator, Mark Siedner, Massachusetts General Hospital
- Investigators
- Mark J Siedner, MD MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445079
- Sponsor's protocol ID
- 2014P001928
- Acronym
- UGANDAC
- Status last verified
- Mar 2019
- First submitted
- 6 May 2015
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Siedner MJ, Bibangambah P, Kim JH, Lankowski A, Chang JL, Yang IT, Kwon DS, North CM, Triant VA, Longenecker C, Ghoshhajra B, Peck RN, Sentongo RN, Gilbert R, Kakuhikire B, Boum Y 2nd, Haberer JE, Martin JN, Tracy R, Hunt PW, Bangsberg DR, Tsai AC, Hemphill LC, Okello S. Treated HIV Infection and Progression of Carotid Atherosclerosis in Rural Uganda: A Prospective Observational Cohort Study. J Am Heart Assoc. 2021 Jun 15;10(12):e019994. doi: 10.1161/JAHA.120.019994. Epub 2021 Jun 5.
PubMed 34096320
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Atherosclerosis Among Older-Age People in Southwestern Uganda
- ClinicalTrials.gov ID
- NCT02445079
- Acronym / sponsor ID
- UGANDAC / 2014P001928
- Conditions
- HIV, Cardiovascular Disease, Chronic Obstructive Pulmonary Disease, Atherosclerosis, Hypertension, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology, University of California, San Francisco, Ragon Institute of MGH, MIT and Harvard, National Institutes of Health (NIH), Harvard University
- Study start
- Dec 2013
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV infected | – | Other: This is an observational study onlyHIV infected sub-group |
| HIV uninfected | – | Other: This is an observational study onlyHIV uninfected sub-group, age and gender matched to the HIV-infected group |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study recruits two sub-groups of participants: Study Group 1: -HIV infected persons aged 40 and older, in care at the Immune Suppression Syndrome HIV Clinic at Mbarara Regional Referral Hospital Study Group 2: -Community-based, HIV uninfected persons recruited from the catchment area of the Mbarara Regional Referral Hospital (greater Mbarara), and age and gender-matched to Group 1 participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational study onlyObservational study only | Other | HIV infected, HIV uninfected |
Primary outcome
Baseline prevalence and incident change in carotid intima media thickness
Time frame: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)
Measured by carotid ultrasonography
4 secondary outcomes
Baseline prevalence and incident change in carotid plaque
Time frame: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)
Baseline prevalence and incident change in ischemic heart disease
Time frame: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)
Baseline prevalence and incident change in peripheral arterial disease
Time frame: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)
Baseline prevalence and incident change in chronic obstructive pulmonary disease
Time frame: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Derived from this study: PubMed 34096320Siedner MJ, Bibangambah P, Kim JH, Lankowski A, Chang JL, Yang IT, Kwon DS, North CM, Triant VA, Longenecker C, Ghoshhajra B, Peck RN, Sentongo RN, Gilbert R, Kakuhikire B, Boum Y 2nd, Haberer JE, Martin JN, Tracy R, Hunt PW, Bangsberg DR, Tsai AC, Hemphill LC, Okello S. Treated HIV Infection and Progression of Carotid Atherosclerosis in Rural Uganda: A Prospective Observational Cohort Study. J Am Heart Assoc. 2021 Jun 15;10(12):e019994. doi: 10.1161/JAHA.120.019994. Epub 2021 Jun 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J Siedner, MD MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Cardiovascular Disease, run by Massachusetts General Hospital at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline prevalence and incident change in carotid intima media thickness (time frame: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02445079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.