Impact of HIV-infection on Clinical Characteristics and Outcomes on Stroke in Uganda

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).

Study Overview

• Status: Completed
• Conditions: Stroke; HIV
• Intervention / Treatment: Other: Observational study

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Uganda
  • Mbarara, Uganda, 00256
    • Mbarara Regional Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population of HIV-infected and uninfected individuals are both drawn from the three hospitals in geographically different parts of Uganda.

Description

Inclusion Criteria:

• ≥ 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

Exclusion Criteria:

• Presumed non-vascular etiology of neurodeficit (ie, trauma, tumor, brain abscess)
• Pregnant, as defined by a positive urine beta-hCG

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV infected with stroke; No intervention will be administered	Other: Observational study; No intervention
HIV uninfected with stroke; No intervention will be administered	Other: Observational study; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Poor stroke outcome	modified Rankin Scale [mRS] > 2 or mortality	30 days follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Poor stroke outcome	modified Rankin Scale [mRS] > 2 or mortality	1 year follow-up

Collaborators and Investigators

• Sponsor: Mbarara University of Science and Technology
• Collaborators: Massachusetts General Hospital
• Investigators: Study Chair: Mark Siedner, MD, Massachusetts General Hospital; Principal Investigator: Amir Abdallah, MD, Mbarara University of Science and Technology

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): December 1, 2020

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (ACTUAL): March 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; HIV; Uganda; Cerebral vascular accident
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Stroke; HIV Infections
• Other Study ID Numbers: 01/31-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be directly entered into a database and analysed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No