Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05666882 |
Other study ID # |
HIVIC |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 1, 2022 |
Est. completion date |
February 28, 2024 |
Study information
Verified date |
December 2022 |
Source |
Ankara University |
Contact |
Cigdem Hatipoglu, Prof |
Phone |
+905326951946 |
Email |
cigdemhatip[@]yahoo.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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
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.