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).
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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Eğitim ve Araştırma Hastanesi
Ankara
Cigdem Hatipoglu, Prof
ilker kurkcu, ilker.kurkcu@sentez-cro.com
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.
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.
- First posted28 Dec 2022
- Study start1 Jun 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilker Kurkcu, Ankara University
- Investigators
- ilker kurkcu, Study chair, Sentez-CRO
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05666882
- Acronym / sponsor ID
- HIV-IC / HIVIC
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 28 Dec 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.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who apply to hospital to any clinic will be screened
Key inclusion criteria (1 listed)
- All patients who apply to hospital to any clinic will be screened
Key exclusion criteria (1 listed)
- Due to design of trial there will not be any exclusion criteria since all patients will be screened
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 |
|---|---|---|
| Non-interventionalNon-interventional | Other | – |
Primary outcome
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
Change in the number of HIV diagnosis before and after the integration of the indicator conditions and diseases to hospital automation system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No
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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.
ilker kurkcu study chair
Sentez-CRO
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 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.