The HIV Testing Trends and Outcomes at a Johannesburg Trauma ICU Unit

• Sponsor: University of Witwatersrand, South Africa (Other)
• Overall Status: Completed
• CT.gov ID: NCT05484947
• Collaborator: (none)
• Enrollment: 868
• Location: 1
• Actual Duration (Months): 55.5
• Patients Per Site Per Month: 15.6

Study Details

Study Description

Brief Summary

A retrospective observational study on the HIV testing trend and outcomes in a trauma population admitted to a critical care unit for care.

Condition or Disease	Intervention/Treatment	Phase
Outcome, Fatal	Diagnostic Test: Elisa HIV testing

Detailed Description

Trauma ICU admission of 18 years and older were enrolled in the study. The HIV status was further divided into HIV-positive, HIV-negative, and HIV-unknown subgroups. The gender, ages, mechanism of injury, injuries sustained, ISS, physiological data, septic-related complications, and in-hospital mortality were noted and further analyzed.

Descriptive statistics were utilised using STATA version 15, and a p-value of <0.05 was considered statistically significant.

Study Design

• Study Type: Observational
• Actual Enrollment: 868 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The HIV Testing Trends and Outcomes at a Johannesburg Trauma ICU Unit
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Aug 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
HIV-positive Those that were actually tested and had HIV-positive results	Diagnostic Test: Elisa HIV testing; HIV testing on a voluntary basis
HIV-Negative Those tested and had HIV-negative results	Diagnostic Test: Elisa HIV testing; HIV testing on a voluntary basis
HIV-Unknown those who had not volunteered for HIV testing

Outcome Measures

Primary Outcome Measures

1. The HIV testing trends [study period over two years (from 01 January 2017 till 31 December 2018)]

   Number tested for HIV in the study group

2. Outcomes [study period over two years (from 01 January 2017 till 31 December 2018)]

   Septic related complications (wound infections, chest sepsis, septicaemia and sepsis related organ failure incidents

Secondary Outcome Measures

1. Mortality [study period over two years (from 01 January 2017 till 31 December 2018)]

   In-hospital mortality in the cohort

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria: Trauma patients admitted to a Trauma ICU at CMJAH -

Exclusion Criteria: Those under the age of 18 or with incomplete data

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charlotte Maxeke Johanneburg Academic Hospital	Johannesburg	Gauteng	South Africa	2193

Sponsors and Collaborators

• University of Witwatersrand, South Africa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maeyane Stephens Moeng, Professor, University of Witwatersrand, South Africa
• ClinicalTrials.gov Identifier: NCT05484947
• Other Study ID Numbers: Witwatersrand
• First Posted: Aug 2, 2022
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 2, 2022