HIVNCT03072212
Impact of HIV-infection on Clinical Characteristics and Outcomes on Stroke in Uganda
An observational study of HIV and Stroke, run by Mbarara University of Science and Technology at 1 site in Uganda.
Trial summary
The investigators will recruit participants from three tertiary care hospitals in Uganda into an observational cohort study of people living with HIV/AIDS (PLWHA) and HIV-uninfected persons matched for gender and residency, presenting with CT-confirmed stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Observational study
- How many people
- 200 participants
- Where
- 1 siteUganda
- Study dates
- 1 Feb 2017to 1 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of HIV-infected and uninfected individuals are both drawn from the three hospitals in geographically different parts of Uganda.
Who may be able to join
- ≥ 18 years old
- In clinical care at the Mbarara Regional Referral, Mulago National Referral, or Nsambya Hospitals
- Hospital presentation with features of new sudden-onset signs of focal or global disturbance of cerebral function lasting >24 hours (unless interrupted by surgery or death)
- Stroke as presumed etiology of presentation
- CT confirmation of stroke
Who cannot join
- Presumed non-vascular etiology of neurodeficit (ie, trauma, tumor, brain abscess)
- Pregnant, as defined by a positive urine beta-hCG
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will recruit participants from three tertiary care hospitals in Uganda into an observational cohort study of people living with HIV/AIDS (PLWHA) and HIV-uninfected persons matched for gender and residency, presenting with CT-confirmed stroke. We will collect socio demographic, clinical, laboratory, radiologic, cardiac, and clinical neurologic disease measures to investigate the effect of HIV-infection on 1) clinical and radiologic presentation, 2) risk factor profiles; and 3) stroke outcomes (death or disability).
Read the detailed description
The investigators will enroll 100 HIV-infected adults presenting to the emergency department with acute or sub-acute stroke (within 14 days of onset) confirmed by computed tomography (CT) scan at Mbarara Regional Referral, Mulago National Referral, and Nsambya Hospitals in Uganda. We will also enroll 100 HIV-uninfected controls, also presenting with acute or sub-acute stroke, matched by gender and county/district of residence. Participants will be followed for up to one year after enrollment. We plan to complete the following research aims:
Aim 1: To identify the impact of HIV-infection on outcomes after acute or sub-acute stroke in Uganda. Our primary outcome will be poor stroke outcome defined as mortality or poor functional status (modified Rankin Scale [mRS] > 2). The investigators will assess for mortality and functional status at one, three, six, and 12 months after presentation. We will estimate the relative risk of poor outcome by HIV serostatus in both unadjusted models and models adjusted for traditional stroke risk factors. We hypothesize that HIV-infected patients have higher rates of poor stroke outcomes compared to HIV-uninfected patients, and that this difference is, in part, attributable to the presence of concurrent central nervous system opportunistic infections.
Aim 2: To describe the clinical and radiologic characteristics of stroke in Uganda, with particular attention to differences by HIV serostatus. The investigators will describe the clinical presentation of stroke, including history and physical exam findings and presenting modified National Institutes of Health Stroke Scale (mNIHSS) score. The investigators will also compare radiologic characteristics, including location of the stroke and its classification as either ischemic or hemorrhagic. We hypothesize that: i) HIV-infected patients are predominantly younger at the time of presentation, ii) HIV infected-patients have more severe stroke presentations with higher mNIHHS scores, iii) HIV-infected patients are more likely to suffer from ischemic (versus hemorrhagic) stroke, and that iv) HIV-infected patients have a greater proportion of small vessel territory strokes due to the association with central nervous system infections and basal meningitis.
Aim 3: To identify the traditional and HIV-specific risk factors for poor outcome after stroke in Uganda. The investigators will fit regression models to identify predictors of poor outcomes as described in Aim 1, both in the total cohort, and restricted to the HIV-infected cohort. We hypothesize that age, presence of hypertension, dyslipidemia, smoking, and low Glasgow coma score are associated with PSO in Uganda and that HIV-specific predictors of poor outcome are low mid-upper arm circumference (MUAC), low CD4 cell count, high HIV viral load, and report of recent constitutional symptoms.
- Being tested
- Observational study
- Keywords
- HIV, Stroke, Cerebral vascular accident, Uganda
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| HIV infected with stroke | No intervention will be administered Receives: Other: Observational study | |
| HIV uninfected with stroke | No intervention will be administered Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor stroke outcome
modified Rankin Scale [mRS] > 2 or mortality
Measured: 30 days follow-up
Secondary outcomes (1)
Poor stroke outcome
modified Rankin Scale [mRS] > 2 or mortality
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start1 Feb 2017
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Mark Siedner, MD, Study chair, Massachusetts General HospitalAmir Abdallah, MD, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072212
- Sponsor's protocol ID
- 01/31-17
- Status last verified
- Apr 2022
- First submitted
- 2 Mar 2017
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be directly entered into a database and analysed
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of HIV-infection on Clinical Characteristics and Outcomes on Stroke in Uganda
- ClinicalTrials.gov ID
- NCT03072212
- Acronym / sponsor ID
- 01/31-17
- Keywords
- HIV, Stroke, Cerebral vascular accident, Uganda
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 7 Mar 2017 (actual)
- 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.
The investigators will recruit participants from three tertiary care hospitals in Uganda into an observational cohort study of people living with HIV/AIDS (PLWHA) and HIV-uninfected persons matched for gender and residency, presenting with CT-confirmed stroke. We will collect socio demographic, clinical, laboratory, radiologic, cardiac, and clinical neurologic disease measures to investigate the effect of HIV-infection on 1) clinical and radiologic presentation, 2) risk factor profiles; and 3) stroke outcomes (death or disability).
Detailed description
The investigators will enroll 100 HIV-infected adults presenting to the emergency department with acute or sub-acute stroke (within 14 days of onset) confirmed by computed tomography (CT) scan at Mbarara Regional Referral, Mulago National Referral, and Nsambya Hospitals in Uganda. We will also enroll 100 HIV-uninfected controls, also presenting with acute or sub-acute stroke, matched by gender and county/district of residence. Participants will be followed for up to one year after enrollment. We plan to complete the following research aims:
Aim 1: To identify the impact of HIV-infection on outcomes after acute or sub-acute stroke in Uganda. Our primary outcome will be poor stroke outcome defined as mortality or poor functional status (modified Rankin Scale [mRS] > 2). The investigators will assess for mortality and functional status at one, three, six, and 12 months after presentation. We will estimate the relative risk of poor outcome by HIV serostatus in both unadjusted models and models adjusted for traditional stroke risk factors. We hypothesize that HIV-infected patients have higher rates of poor stroke outcomes compared to HIV-uninfected patients, and that this difference is, in part, attributable to the presence of concurrent central nervous system opportunistic infections.
Aim 2: To describe the clinical and radiologic characteristics of stroke in Uganda, with particular attention to differences by HIV serostatus. The investigators will describe the clinical presentation of stroke, including history and physical exam findings and presenting modified National Institutes of Health Stroke Scale (mNIHSS) score. The investigators will also compare radiologic characteristics, including location of the stroke and its classification as either ischemic or hemorrhagic. We hypothesize that: i) HIV-infected patients are predominantly younger at the time of presentation, ii) HIV infected-patients have more severe stroke presentations with higher mNIHHS scores, iii) HIV-infected patients are more likely to suffer from ischemic (versus hemorrhagic) stroke, and that iv) HIV-infected patients have a greater proportion of small vessel territory strokes due to the association with central nervous system infections and basal meningitis.
Aim 3: To identify the traditional and HIV-specific risk factors for poor outcome after stroke in Uganda. The investigators will fit regression models to identify predictors of poor outcomes as described in Aim 1, both in the total cohort, and restricted to the HIV-infected cohort. We hypothesize that age, presence of hypertension, dyslipidemia, smoking, and low Glasgow coma score are associated with PSO in Uganda and that HIV-specific predictors of poor outcome are low mid-upper arm circumference (MUAC), low CD4 cell count, high HIV viral load, and report of recent constitutional symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV infected with stroke | – | Other: Observational studyNo intervention will be administered |
| HIV uninfected with stroke | – | Other: Observational studyNo intervention will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of HIV-infected and uninfected individuals are both drawn from the three hospitals in geographically different parts of Uganda.
Key inclusion criteria (5 listed)
- ≥ 18 years old
- In clinical care at the Mbarara Regional Referral, Mulago National Referral, or Nsambya Hospitals
- Hospital presentation with features of new sudden-onset signs of focal or global disturbance of cerebral function lasting >24 hours (unless interrupted by surgery or death)
- Stroke as presumed etiology of presentation
- CT confirmation of stroke
Key exclusion criteria (2 listed)
- Presumed non-vascular etiology of neurodeficit (ie, trauma, tumor, brain abscess)
- Pregnant, as defined by a positive urine beta-hCG
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 |
|---|---|---|
| Observational studyNo intervention | Other | HIV infected with stroke, HIV uninfected with stroke |
Primary outcome
Poor stroke outcome
Time frame: 30 days follow-up
modified Rankin Scale [mRS] > 2 or mortality
1 secondary outcome
Poor stroke outcome
Time frame: 1 year follow-up
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 5 Apr 2022.
- Individual participant dataSharing planned: No. Data will be directly entered into a database and analysed
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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 Siedner, MD study chair
Massachusetts General Hospital
Amir Abdallah, MD principal investigator
Mbarara University of Science and Technology
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 Stroke, run by Mbarara University of Science and Technology 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?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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 5 Apr 2022. 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?
Poor stroke outcome (time frame: 30 days follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2022.