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

NCT03072212 | Completed

• 1 other identifier: 01/31-17
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

HIV; Stroke

Keywords

HIV; Stroke; Cerebral vascular accident; Uganda

Outcome Measures

Primary Outcomes (1)

• Poor stroke outcome

  modified Rankin Scale \[mRS\] \> 2 or mortality

  30 days follow-up

Secondary Outcomes (1)

• Poor stroke outcome

  1 year follow-up

Study Arms (2)

HIV infected with stroke

No intervention will be administered

Other: Observational study

HIV uninfected with stroke

No intervention will be administered

Other: Observational study

Interventions

Observational study OTHER

No intervention

HIV infected with stroke; HIV uninfected with stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

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

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Mbarara Regional Referral Hospital

Mbarara, 00256, Uganda

Location

MeSH Terms

Conditions

Stroke

Interventions

Observation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Mark Siedner, MD

  Massachusetts General Hospital

  STUDY CHAIR

• Amir Abdallah, MD

  Mbarara University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 7, 2017
• Study Start: February 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)