Outcome, FatalNCT05484947
The HIV Testing Trends and Outcomes at a Johannesburg Trauma ICU Unit
An observational study of Outcome, Fatal, run by University of Witwatersrand, South Africa at 1 site in South Africa.
Trial summary
A retrospective observational study on the HIV testing trend and outcomes in a trauma population admitted to a critical care unit for care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outcome, Fatal
- What is being tested?
- Elisa HIV testing
- How many people
- 868 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jan 2017to 18 Aug 2021
- 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
- Adult, Older adult
Study population: Major Trauma patients admitted to a Trauma unit at a Johannesburg Trauma Unit
Inclusion Criteria: Trauma patients admitted to a Trauma ICU at CMJAH -
Exclusion Criteria: Those under the age of 18 or with incomplete data
-
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Charlotte Maxeke Johanneburg Academic Hospital
Johannesburg, Gauteng, 2193
About this study
A retrospective observational study on the HIV testing trend and outcomes in a trauma population admitted to a critical care unit for care.
Read the 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.
- Conditions
- Outcome, Fatal
- Being tested
- Elisa HIV testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elisa HIV testingDiagnostic test
HIV testing on a voluntary basis
| Study group | Role | What they receive |
|---|---|---|
| HIV-positive | Those that were actually tested and had HIV-positive results Receives: Diagnostic Test: Elisa HIV testing | |
| HIV-Negative | Those tested and had HIV-negative results Receives: Diagnostic Test: Elisa HIV testing | |
| HIV-Unknown | those who had not volunteered for HIV testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The HIV testing trends
Number tested for HIV in the study group
Measured: study period over two years (from 01 January 2017 till 31 December 2018)
Outcomes
Septic related complications (wound infections, chest sepsis, septicaemia and sepsis related organ failure incidents
Measured: study period over two years (from 01 January 2017 till 31 December 2018)
Secondary outcomes (1)
Mortality
In-hospital mortality in the cohort
Measured: study period over two years (from 01 January 2017 till 31 December 2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Jan 2017
- Primary completion31 Dec 2018
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcome, FatalStudies 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
- Retrospective
- Enrolment
- 868 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maeyane Stephens Moeng, University of Witwatersrand, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484947
- Sponsor's protocol ID
- Witwatersrand
- Status last verified
- Jul 2022
- First submitted
- 23 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: only with close collaboration of future studies
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HIV Testing Trends and Outcomes at a Johannesburg Trauma ICU Unit
- ClinicalTrials.gov ID
- NCT05484947
- Acronym / sponsor ID
- Witwatersrand
- Conditions
- Outcome, Fatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 868 participants (actual)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 2 Aug 2022 (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.
A retrospective observational study on the HIV testing trend and outcomes in a trauma population admitted to a critical care unit for care.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV-positive | – | Diagnostic Test: Elisa HIV testingThose that were actually tested and had HIV-positive results |
| HIV-Negative | – | Diagnostic Test: Elisa HIV testingThose tested and had HIV-negative results |
| HIV-Unknown | – | –those who had not volunteered for HIV testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major Trauma patients admitted to a Trauma unit at a Johannesburg Trauma Unit
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 |
|---|---|---|
| Elisa HIV testingHIV testing on a voluntary basis | Diagnostic test | HIV-Negative, HIV-positive |
Primary outcome
The HIV testing trends
Time frame: study period over two years (from 01 January 2017 till 31 December 2018)
Number tested for HIV in the study group
Outcomes
Time frame: 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
1 secondary outcome
Mortality
Time frame: study period over two years (from 01 January 2017 till 31 December 2018)
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 2 Aug 2022.
- Individual participant dataSharing planned: Undecided. only with close collaboration of future studies
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Outcome, Fatal, run by University of Witwatersrand, South Africa at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Aug 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 South Africa. 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?
The HIV testing trends (time frame: study period over two years (from 01 January 2017 till 31 December 2018)). The study lists 2 primary outcomes in all. 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 2 Aug 2022.