Clinical Trials

MainTitle

HIV and Stroke Outcomes in Uganda

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2017 by Mbarara University of Science and Technology

Sponsor
Mbarara University of Science and Technology

Collaborator
Massachusetts General Hospital

Information provided by (Responsible Party)
Mbarara University of Science and Technology
ClinicalTrials.gov Identifier
NCT03072212

First received: March 2, 2017
Last updated: March 2, 2017
Last Verified: March 2017
History of Changes
Purpose

Purpose

We 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).

Condition Intervention
HIV
Stroke

Other : Observational study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of HIV on Stroke Characteristics and Outcomes in Uganda

Further study details as provided by Mbarara University of Science and Technology:

Primary Outcome Measures

  • Poor stroke outcome [ Time Frame: 30 days follow-up ]
    modified Rankin Scale [mRS] > 2 or mortality
Secondary Outcome Measures:
  • Poor stroke outcome [ Time Frame: 1 year follow-up ]
    modified Rankin Scale [mRS] > 2 or mortality

Estimated Enrollment: 200
Study Start Date: February 1, 2017
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Detailed Description:

We 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). We 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. We will describe the clinical presentation of stroke, including history and physical exam findings and presenting modified National Institutes of Health Stroke Scale (mNIHSS) score. We 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. We 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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
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.

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03072212

Contacts

Contact:   Amir Abdallah, MD +256 702447125 aamir@must.ac.ug

Locations

Uganda
Mbarara Regional Referral Hospital Recruiting
Mbarara, Uganda, 00256
Contact: Amir Abdallah, MD    +256 702447125    aamir@must.ac.ug

Sponsors and Collaborators

Mbarara University of Science and Technology
Massachusetts General Hospital
More Information

More Information


Responsible Party: Mbarara University of Science and Technology  
ClinicalTrials.gov Identifier: NCT03072212   History of Changes  
Other Study ID Numbers: 01/31-17  
Study First Received: March 2, 2017  
Last Updated: March 2, 2017  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Mbarara University of Science and Technology:

HIV
Stroke
Cerebral vascular accident
Uganda

Additional relevant MeSH terms:
Stroke

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.