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HIV InfectionsHIV-ICNCT05666882

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

An observational study of HIV Infections, run by Ankara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Any age
Conditions the study is for
HIV Infections
What is being tested?
Non-interventional
How many people
10,000 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2022to 28 Feb 2024
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients who apply to hospital to any clinic will be screened

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Cigdem Hatipoglu, Prof contact

+905326951946

cigdemhatip@yahoo.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ankara Eğitim ve Araştırma Hastanesi

    Ankara

    Cigdem Hatipoglu, Prof

    ilker kurkcu, ilker.kurkcu@sentez-cro.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: HIV-IC: Effect on the HIV Diagnosis Rates of Integration of AIDS Defining and Indicator Conditions Into the Hospital Information Systems (HIS): 2 Phase, Multicenter Retrospective Study

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.

Conditions
HIV Infections
Being tested
Non-interventional
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-interventionalOther

    Non-interventional

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through study completion, an average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2022
  2. Study start1 Jun 2022
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion28 Feb 2024 (estimated)

Resources

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
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05666882
Sponsor's protocol ID
HIVIC
Acronym
HIV-IC
Status last verified
Dec 2022
First submitted
16 Dec 2022
Last updated
28 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by Ankara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 28 Dec 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 Turkey (Türkiye). 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cigdem Hatipoglu, Prof (+905326951946, cigdemhatip@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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 28 Dec 2022.

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