CClinicalTrials.gg
Status unknownNCT05666882HIV-ICUpdated Dec 28, 2022

Effect on the HIV Diagnosis Rates of Integration of AIDS Indicator Conditions Into the Hospital Information Systems

An observational study in HIV Infections, sponsored by Ankara University. Status unknown at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2022-12-28.

Sponsored by Ankara University · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,000
Sex
All
01

Study summary

to describe the change in the number of HIV diagnosis before and after the integration of the indicator conditions and diseases to hospital automation system

Read the detailed description

Scientific Basis/Rationale The HIV infection was first diagnosed in our country in 1985, and the number of the patients diagnosed with this infection has been gradually increasing since then. The number of these patients was found 21.520 in December 2018. Having CD4 cell count \<350 cell/mm3 at the time of diagnosis or having an AIDS defining illness regardless of CD4 count has been defined as late diagnosis. 48-52% of HIV-positive cases have been shown to receive late diagnosis in the studies conducted in our country. It is being reported that there are no strategies of HIV screening for risky individuals and a significant part of the patients receive HIV diagnosis accidentally or during differential diagnosis of certain diseases. In the patients having late diagnosis, the treatment response is low and slow whereas progression to AIDS and death rates are high. The patients who could not be diagnosed also contribute to spread of the infection in the society. Therefore, it is significant that these patients should have early diagnosis and thus they could start treatment at the early phases of the infection in order to keep the disease under control. Hypothesis In the studies, it was reported that most of the patients with late diagnosis were the patients who were not defined to have a risk of HIV infection, although these patients had a number of applications to the healthcare centers before the diagnosis of the disease, HIV infection was not considered because they were not in the risky patient group and no tests were requested; therefore, the opportunities of the diagnosis could be missed. Diseases and the indicator conditions for which HIV test should be requested other than AIDS descriptive diseases are also identified in the studies conducted. The objectives of this study include studying the indicator conditions and diseases for which HIV test should be requested, determining the ratio of HIV test requests related to these conditions and diseases, integrating these diseases into the automation systems used in the hospitals and increasing the rate of HIV diagnosis by this means, prevention of missing diagnosis opportunities and raising awareness on this issue.

Primary Objective Change in the number of HIV diagnosis before and after the integration of the indicator conditions and diseases to hospital automation system Secondary Objectives Change in the number of HIV test requests before and after the integration of the indicator conditions and diseases to hospital automation system Assessment of CD4 levels at the time of diagnosis before and after the integration of the indicator conditions and diseases to hospital automation system Study Design and Research Methods This study has been designed as a multi-center retrospective cohort study. The indicator conditions and diseases for which HIV test should be requested will be recorded from the automation systems of the hospitals, and the rate of HIV test requests and rate of HIV positivity when the test was requested will be recorded for the all patients applied to hospital retrospectively for the past 6 months. For this period, due to retrospective design, physicians working at the hospitals do not have any information about the study. After the necessary approvals the indicator conditions and diseases for which HIV test should be requested shall be integrated into the hospitals automation systems and a warning stating that HIV test should be requested at the moment when these diseases and conditions are diagnosed shall pop-up. All the physicians working at the hospitals shall be notified of this activation by means of a letter. After this activation, 6 months later second retrospective step (phase) will start that, we will record the indicator conditions and diseases for which HIV test should be requested, and the rate of HIV test requests and the rate of HIV positivity when the test is requested will be recorded. During the study, the information obtained from the hospital automation system including age, gender, date of diagnoses, CD4 cell counts at the time of diagnoses, the HIV RNA levels, immigration status, concomitant diseases, and the residential area of all patients diagnosed with HIV infection shall be recorded on the appropriate forms. The characteristics of the patients that are diagnosed due to the indicator conditions and diseases for which HIV test should be requested shall be compared with the patients that are diagnosed due to other reasons. The HIV infection diagnoses rates during the two phases of the study shall also be compared. Furthermore, the patients shall be evaluated according to their CD4 counts at the time of the diagnosis, and shall be divided into two groups of patients as late diagnoses or not. We shall evaluate whether or not there is a difference regarding the rate of the patients with late diagnoses during the two phases of the study, and both groups shall be compared with respect to receiving late diagnosis factors.

The ethical approval of the study shall be obtained from the Ethical Committee of Ankara Training and Research Hospital. The centers participating in the study will obtain their approval to participate to the study from the centers where they work, using the ethical approval obtained form Ankara Training and Research Hospital. Each hospital will be responsible for the arrangements that must be made regarding the hospital automation system.

02

Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who apply to hospital to any clinic will be screened

Inclusion criteria

  • All patients who apply to hospital to any clinic will be screened

Exclusion criteria

Exclusion Criteria:

  • Due to design of trial there will not be any exclusion criteria since all patients will be screened
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,000 participants (estimated)
Patient registry
No

Interventions

  • OtherNon-interventional

    Non-interventional

06

What researchers measure

Primary outcomes

  1. Change in the number of HIV diagnosis before and after the integration of the indicator conditions and diseases to hospital automation system

    Change in the number of HIV diagnosis before and after the integration of the indicator conditions and diseases to hospital automation system

    Time frame: Through study completion, an average of 18 months

07

Study locations

1 of 1 sites recruiting
  • Ankara Eğitim ve Araştırma Hastanesi
    Ankara, Turkey
    • Cigdem Hatipoglu, Prof · Contact
    • ilker kurkcu · Contact · ilker.kurkcu@sentez-cro.com
    • Cigdem Hatipoglu, prof · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05666882
Lead sponsor
Ankara University
Responsible party
Ilker Kurkcu (Infectious Diseases Department, Ankara University) — Principal investigator
First posted
Dec 28, 2022
Start date
Jun 1, 2022
Primary completion
Dec 30, 2023 (estimated)
Completion
Feb 28, 2024 (estimated)
Last update
Dec 28, 2022

Study contacts

Cigdem Hatipoglu, Prof
Contact
cigdemhatip@yahoo.com
+905326951946
Ilker Kurkcu
Contact
ilker.kurkcu@sentez-cro.com
+905326354515
ilker kurkcu
study chair · Sentez-CRO

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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