Implement a survey initiative to assess HIV prevalence for one or more diseases and/or conditions within a specific segment of the population not yet diagnosed with HIV and that present for care with the specific disease/condition.
ID
Source
Brief title
Condition
- Viral infectious disorders
- Peripheral neuropathies
- Cervix disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
How often does HIV occur (prevalence) in the diseases investigated.
Secondary outcome
If person is found positive: patients characteristics like risk behaviour.
Background summary
Most patients infected with HIV across the European continent remain
undiagnosed; although this percentage varies markedly from 15-80% across the
continent. Undiagnosed HIV is harmful to the person infected as appropriate
health interventions are then delayed until the HIV infection is diagnosed. It
is also detrimental to society as persons unaware of their HIV infection may
transmit more frequently to others than persons that are aware of their HIV
status.
An important public health issue is hence how to diagnose more HIV-infected
persons earlier in the course of their infection. In the US, the Centres for
Disease Control and Prevention (CDC) have introduced testing guidelines where
all persons are tested upon entry into the hospital system (the *opt-out*
testing guidelines).
At the *HIV in Europe* conference held in November 2007, the general sense was
that such an approach would not be suitable for Europe. Conversely, the
conference recommended further development of focused HIV testing in patients
presenting with certain clinical conditions and/or diseases (i.e. indicator
condition guided testing).
Cost effectiveness analyses suggests cost savings if a population with a HIV
prevalence of 1% or more are tested although this rate may be as low as 0.1%.
However, there is very little * if any - evidence on HIV prevalence for various
conditions and diseases in specific and easy to identify sections of society.
This is true in general and particularly across the European continent.
Study objective
Implement a survey initiative to assess HIV prevalence for one or more diseases
and/or conditions within a specific segment of the population not yet diagnosed
with HIV and that present for care with the specific disease/condition.
Study design
The implementation will be conducted in two phases. Protocol version 1.0
implemented surveys in 8 diseases associated with high-risk behaviour or immune
deficiency. Protocol version 1.1 will implement surveys of 11
diseases/conditions (listed below).
A. List of Indicator Diseases
The list of diseases below is not indicative of the most important indicator
diseases for HIV but rather a list of diseases suggested for surveillance.
During protocol version 1.0, a total of 3588 patients were enrolled. Protocol
version 1.1 will enrol patients presenting with the following
diseases/conditions:
1. Presenting for care of malignant lymphoma, irrespective of type
2. Presenting for care of cervical or anal dysplasia or cancer, (Cervical CIN
II and above)
3. Presenting for care of Hepatitis B or C virus infection (acute or chronic *
and irrespective of time of diagnosis relative to time of survey),
4. Presenting with ongoing mononucleosis-like illness
5. Presenting with unexplained leukocytopenia or thrombocytopenia lasting at
least 4 weeks
6. Presenting with seborrheic dermatitis / exanthema
7. Presenting with pneumonia, admitted to hospital for at least 24h
8. Presenting with unexplained lymphadenopathy
9. Presenting with peripheral neuropathy of unknown cause (diagnosed by
neurologist)
10. Presenting with primary lung cancer
11. Presenting with severe or recalcitrant psoriasis (newly diagnosed)
For the Netherlands the selected diseases are cervical of anal dysplasia or
cancer, Hepatitis B or C, peripheral neuropathy.
Persons with these illnesses will be approached to conduct an HIV test.
If bloodtests are already performed routinely, an HIV test will be done from
the collected blood after the patient gave consent 24 hours later.
If no routine bloodtests are performed, a rapid HIV test will be done at the
next visit after the patient gave consent.
If the HIV test turns out positive, specific care with follow up will be
offered.
Demografic characteristics will be collected. In case of a positive test,
additional information will be collected.
Data storage will be performed anonimously.
The aim of the study is to collect data from at least 200 persons.
The general practitioner will be informed about the testresult.
Study burden and risks
A rapid hiv test will be done. If the test is positive, a tube of blood will be
taken from the patient. This can cause a haemorrhage.
Panum Institute, Building 21.1 Blegdamsvej 3B
Kopenhagen N 2200
DK
Panum Institute, Building 21.1 Blegdamsvej 3B
Kopenhagen N 2200
DK
Listed location countries
Age
Inclusion criteria
1. Presenting for care of cervical or anal dysplasia or cancer, (Cervical CIN II and above)
2. Presenting for care of Hepatitis B or C virus infection (acute or chronic * and irrespective of time of diagnosis relative to time of survey
3. Presenting with peripheral neuropathy of unknown cause (diagnosed by neurologist
- HIV status unknown
Exclusion criteria
HIV positive
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL41999.100.12 |