Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
mario.poljak@mf.uni-lj.si
erasmus.smit@heartofengland.nhs.uk
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INTRODUCTION
HIV/AIDS in Europe
As of the end of December 2004, there have been 294,571 reported AIDS diagnoses in
Europe. Of these patients, at least 163,831 have died. European countries that have national
reporting systems for HIV infection had cumulatively reported 646,142 diagnoses of HIV
infection by the end of June 2005 (UNAIDS, 2006a).
Estimated HIV prevalence (the proportion of adults living with HIV) in Europe varies from
below 0.1% in parts of Central Europe to above 1% in parts of the former Soviet Union
(UNAIDS, 2006b). According to UNAIDS estimates, around 2.4 million people were living
with HIV in Europe and Central Asia at the end of 2006 (UNAIDS, 2006a), of whom at least
40% remain undiagnosed.
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follow these recommendations must be based on the professional judgement of the clinician,
consideration of individual patient circumstances and available resources.
Recommendations:
The recommended way of HIV testing in STI/GUM settings is provider-initiated HIV testing
using opt-out approach. Thus, any individual presenting to a STI/GUM facility should be
offered an HIV test regardless of signs or symptoms of disease or risk factors for infection.
(IIb, B)
Pre-test and post-test discussions are necessary and the informed consent, counselling and
confidentiality must be clearly observed during HIV testing in STI/GUM settings. (IV, C)
In the case of inability to comply with the recommendation to test all individuals presenting
to a STI/GUM facility, after clinical examination and pre-test discussion priority should be
given to groups with higher possibility of HIV-infection. (IV, C)
The HIV testing should not be restricted to newly presented patients only, but all re-
presenting previously HIV negative patients should be offered and encouraged to have HIV
testing following possible re-exposure. (IV, C)
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dramatically improve the life expectancy of the individual (Gazzard, 2006; Soria, 2007) (IIa).
HAART is an important contributor in reducing transmission due to the reduction in HIV
burden and therefore infectivity in those individuals who are diagnosed early and treated
(Quinn, 2000) (IIa); there is also consensus that it is the best to start HAART before the
onset of severe immunosuppression (Gazzard, 2006) (IIb). Regardless of how
recommendations to initiate antiretroviral therapy might change in the future, early diagnosis
of HIV infection will remain preferable to late diagnosis (Thorvaldsen, 2001). Although meta-
analysis of 27 reports published from 1985-1997 suggested no significant impact of HIV
testing and counselling on sexual risk behaviour (Weinhardt, 1999), recent studies clearly
showed that once diagnosed with HIV infection, sexual and needle sharing risk behaviours of
infected people decrease substantially, while those who are unaware of their HIV status, do
not change their high risk behaviours (Fox, 1987; van Griensven, 1989; Doll, 1990; Clearly,
1991; Dawson, 1991; Desenclos, 1993; Wenger, 1994; Gibson, 1999; Marks, 2005; Marks,
2006) (Ia). Rates of unprotected sex, HIV transmission and acquisition of other sexually
transmitted diseases among HIV-positive individuals are significantly reduced after diagnosis
of HIV infection (Kamb, 1998; Allen, 2003; Crepas, 2006; Marks, 2006) (Ia).
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must specifically decline or defer the HIV test if they do not want the test to be performed
(WHO, 2007).
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individuals who have past/current history of STI/STD particularly those associated
with an increased risk of HIV transmission;
individuals who have been the victims of sexual assault;
individuals who are known contacts of HIV infected patients;
intravenous drug users (IVDU) with risk needle sharing behaviours;
individuals who come or return from countries with a high HIV prevalence;
individuals who travel outside Europe with exposure to high risk activity;
individuals who have received blood transfusion or other blood products before
introduction of routine HIV screening (in most European countries before 1985);
any pregnant woman regardless of risk factors.
Recommendations:
Venous blood is the preferred specimen for HIV testing. (IIa, B)
HIV testing in samples other than venous blood should be avoided unless venepuncture is
difficult or not possible. (IV, C)
In HIV testing use the most sensitive test as the first screening test and confirm reactive
results with more specific test which preferably test with a different method/antigens. (III,
B)
All HIV testing procedures should be performed to the highest quality standard to ensure
consistency and reliability of results. (IV, C)
Fourth generation screening assays which simultaneously test for anti-HIV-1 antibodies
and HIV-1 p24 antigen as well as anti-HIV-2 antibodies are recommended to be used as
HIV screening tests in European STI/GUM settings. (IV, C)
Confirmation of reactive screening test results should be performed in a specialist
laboratory with experience in HIV confirmation. (IV, C)
Line-Immuno Assay (LIA) or Western blot (WB) which distinguishes between the different
antibodies against the individual HIV-1 and HIV-2 antigenic components is the preferred
final confirmation assay. (IV, C)
A subsequent second blood sample should be tested for confirmation of HIV infection to
exclude mislabelling, misidentification and clinic/laboratory mix-ups. (IV, C)
The patient can be told after confirmation of the first blood that he/she is HIV infected but
final assurances can only be given after a second confirmatory blood. (IV, C)
Health-care provider using rapid HIV tests should be aware that these do not test for p24
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antigen and may be false-negative early on during primary HIV infection. (III, B)
Sites using point of care tests should preferably be overseen by the local laboratory and
have a robust quality assurance programme. (IV, C)
All laboratories should provide their latest external quality control scores to their users
upon request. (IV, C)
There should be active encouragement to destigmatise HIV and there should be a system
in place to provide anonymous testing should a patient want it. (IV, C)
Diagnosis or exclusion of an HIV infection is based on testing for the presence of anti-HIV
specific antibodies and/or HIV-1 p24 antigen and/or viral RNA/DNA. HIV testing needs to
adhere to strict guiding principals in order to obtain near 100% sensitivity and positive
predictive value due to the seriousness of misdiagnosing a patient.
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HIV testing procedures should be performed to the highest quality standard to ensure
consistency and reliability of results (IV, C).
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during seroconversion, as measured by the optical density signal in EIAs or intensity of the
band/dot in a rapid test, dramatically increase over days.
Specimens from HIV-infected individuals typically give rise to strong, and often maximum,
signals in most screening tests whereas false reactive specimens infrequently do (Parry,
2003). However, this is not a reliable basis on which to make a diagnosis of HIV infection,
and confirmatory testing is essential. For this reason a patient should never be told that
he/she is HIV positive based on screening test result alone, especially if the signal (optical
density or band/spot) is weak. False reactive results can occur due to human error, in
individuals with acute Epstein-Barr virus or human cytomegalovirus infection, autoimmune
disorders, hypergammaglobulinemias, multiple myeloma, hemophilia, and hemodialysis
patients. In general, the percentage of false reactive EIA results decreases as the prevalence
of HIV infection in particular population increases (Shapiro, 1999).
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he/she is most probably HIV infected but final assurances can only be given after a second
confirmatory blood.
Line-Immuno Assay (LIA) or Western blot (WB) which distinguishes between the different
antibodies against the individual HIV-1 and HIV-2 antigenic components is the preferred final
confirmation assay (IV, C). Confirming initially reactive result with two different confirmation
tests which have high specificities virtually excludes a false positive result (UNAIDS/WHO,
1997). Although exceptional cases of false positive results of a single WB or LIA have been
described in literature (Tarjan, 1998; Mylonakis, 2000; Seme, 2006), the two-test
confirmatory strategy has never been recommended. The interpretation of results of
confirmatory tests should not deviate in any manner from the manufactures’ instructions.
Some laboratories employ two further EIAs or rapid tests to resolve the HIV status of initially
reactive or indeterminate screening test result. Although this strategy will suffice for the
majority of cases, there still will be cases where the reactions are weak in all the tests. In
such cases it is recommended to use more specific tests such as a LIA or WB for final
confirmation of HIV infection.
Nucleic acid amplification tests (NAAT) for HIV i.e. HIV-1 viral load or proviral DNA testing as
well as HIV-1 p24 antigen testing with a neutralisation step can be employed to diagnose
seroconversion where the initial screening test gives a weak positive or negative results, but
where seroconversion is highly suspected. However, when using HIV-1 viral load tests for
such purposes, it should be borne in mind that these tests are not licensed for HIV-1
diagnosis, although there is supporting literature showing that they are clinically helpful and
compare favourably with HIV DNA testing (Hecht, 2002). Additionally, both false-positive and
false-negative HIV-1 viral load test results occasionally occur (Rich, 1999; Sherman, 2005;
Marinovich, 2006). Especially, low values of HIV-1 RNA (less than 5000 copies/ml) should be
interpreted with caution and probably not viewed as positive unless it is confirmed on a
subsequent test (IIb). If HIV-1 viral load test is negative, infection with HIV-2 or infection with
the outlier group of HIV-1 should be excluded (CDC, 2006a). Such specimens should be
referred to specialist laboratory with experience in HIV confirmation of such cases. Additional
testing in such specialist laboratory is also recommended when HIV-1 WB results include the
unusual indeterminate pattern of gag (p55, p24, p17) plus pol (p66, p51, p31) bands in the
absence of env (gp160, gp120, gp41) bands (CDC, 2006a).
As recommended, laboratories should test initially by a fourth generation screening assay
and confirm reactive result using a test which does not contain HIV-1 p24 antigen (usually
third generation test). If there is a discrepancy between the third and fourth generation test
results then a separate HIV-1 p24 antigen test with neutralization of the positive result or a
NAAT testing can be performed to diagnose possible early seroconversion. Alternatively, if
on the follow-up sample in addition to fourth generation screening assay the third generation
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screening test also becomes clearly positive then a diagnosis of seroconversion can be
made without further testing. However, it is recommended to finally confirm HIV infection
using LIA or WB.
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Point of care testing is not managed in many cases by the laboratories and their quality
assurance programmes. Currently these test sites, when not affiliated to a laboratory, do not
fall under a licensing body and great care should be taken to ensure that testing fulfils the
highest standards. It is recommended that all testing sites that use POTC must have a
quality assurance programme consisting of quality control and external quality assessment in
place before offering testing as set out by the WHO and CDC (WHO, 2004; CDC, 2007).
They must also have a multi-test confirmation algorithm and a pre-test and post-test
discussion service in place. It would be best practice if rapid testing site’s testing
responsibilities falls under the management of the local laboratory. If this is not logistically
possible then the local laboratory, which has experience in quality assurance schemes,
should at least be consulted to provide leadership and advice (CDC, 2007).
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needle stick injury. However, if feasible it is recommended to store all plasma/serum samples
as long as it is possible.
Recommendations:
The health care provider who orders HIV tests should be familiar with basic laboratory
terminology such as sensitivity, specificity and positive predictive value of tests. (IV, C)
The health-care provider should be aware of what HIV testing algorithm and especially
what HIV screening test their local laboratory is using. (IV, C)
Patients whose specimens test negative on the initial HIV screening should be regarded
as non-infected unless the patient presents with symptoms of primary HIV infection. (IV,
C)
It is recommended that patients have a baseline HIV test done at presentation and if
necessary be repeated at 3 months from the time of high risk exposure. (IIb, B)
Individuals with a high risk exposure to HIV should not be fully reassured until at least 3
months have passed during which they remain seronegative. (IV C)
Recalling patients for a 6 month follow-up should be considered for occupational
exposures especially if post exposure prophylaxis was given, where the tested subject
has an impaired ability to develop antibodies and where there is simultaneous infection
with another viral pathogen. (IV, C)
The health-care provider should advise repeat HIV testing at least annually to all persons
who tested HIV negative but who are likely to be at high risk for HIV. (IV, C)
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The second specimen should be taken at least one week later in the case of an
indeterminate or weakly-reactive screening test. Plasma sample is the preferred second
specimen. (IV, C)
If a good positive screening test cannot be confirmed by other tests and test negative on
repeat testing with the same assay consider the possibility that another sample has
wrongly been sent out as negative i.e. a testing mix-up. (IV, C)
Be cautious when you have weak reactions in all or some of the assays. (IV, C)
Patients who are retested repeatedly following subsequent sexual exposures should have
more intensive counselling to establish the reason and solution for their repeated risk.
They should be made aware of the availability of post exposure prophylaxis. (IV, C)
It is recommended that the health care provider who orders HIV tests be familiar with basic
laboratory terminology such as sensitivity, specificity and positive predictive value of tests
(IV, C). This is not only helpful to interpret the test result correctly, but also to give an
unambiguous answer to the patient during post-test discussion. When interpreting test
results the requesting health care provider should always be kept in mind that no diagnostic
test is 100% accurate, and although the HIV testing have sensitivities and specificities close
to 100%, false positive and false negative results can still occur. Because the prevalence of
HIV in majority of European countries is low, as a general rule false positive HIV screening
tests tend to occur, whilst false negative HIV screening tests (unless a person is in the
window period) are extremely rare. The health-care provider should be aware of what HIV
testing algorithm and especially what HIV screening test their local laboratory is using, e.g.
whether it is a third or fourth generation screening test.
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seroconversion dramatically increases over days. Thus, it is recommended that if the patient
has a seroconversion like illness at time of HIV testing and a negative test result then the test
should be repeated using fourth generation EIAs a week later. The early stage of
seroconversion (first week) is the period of HIV infection in which the differences in the
testing performance of different HIV screening tests are the most pronounced (Parry, 2003).
It is estimated that HIV seroconversion occurs in about 50% of cases around 1 month
following exposure when a third generation screening test is used (Busch, 1995) and 4 to 8
days earlier when a fourth generation screening test is used (Parry, 2003). Another study has
shown that seroconversion occurred in all the study participants within 1 month following
exposure (Lindbäck, 2000). It is recommended that following the initial negative test the
patient is asked to come back for a repeat test at least 3 months after the last exposure or
sooner should symptoms or signs of primary HIV infection appear (Lindbäck, 2000). Repeat
testing of asymptomatic individuals should be according to repeat exposure. Once a patient
has been tested beyond 3 months following a definite exposure and there have been no
subsequent exposures then the patient does not have to be repeat tested.
Case studies of prolonged (only HIV-1 p24 antigen positive for months) or no seroconversion
for up to a year have been described in literature (Farzadegan, 1988; Montagnier, 1997;
Michael, 1997; Reimer, 1997; Rice, 1999; Preiser, 2000). However, these reports were all
tested with older generations of HIV screening tests and many of these long window period
cases tested HIV RNA negative on retesting, suggesting infection was caused by a re-
exposure at a later date. Some older literature also refers to cases where the HIV antibodies
disappeared in patients with advanced AIDS (Pedersen, 1987; Sullivan, 1999). Even though
these cases are very rare they should all be detected by the HIV-1 p24 antigen component of
a current fourth generation screening test.
The CDC guidelines state that one might consider a further follow-up at 6 months if there has
been exposure to a known HIV positive person (CDC, 2001), which in most settings is
impractical and creates a lot of anxiety. In perspective the risk of contracting HIV from a
subsequent episode of unsafe sexual exposure is far greater than the remote possibility of a
prolonged seroconversion. Recalling patients for a 6 month follow-up should be still
considered where the tested subject has an impaired ability to develop antibodies or where
there is a microbiologically proven simultaneous infection with another pathogen such as
human cytomegalovirus (CMV) or hepatitis C virus (HCV). Of note, there has been a case of
prolonged seroconversion in a health care worker who was simultaneously infected with HCV
following a needle stick injury. It was thought that the simultaneous HCV infection influenced
the HIV seroconversion time (Ridzon, 1997).
Recalling patients for a 6 month follow-up should also be considered for occupational
exposures especially if post exposure prophylaxis was given. There is a theoretical, but as
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yet unproven, risk that during post exposure prophylaxis, HIV replication can be inhibited
enough to prolong the window period. For this reason, the advice sometimes given is to
rather retest, not at 3 months following exposure, but rather at 3 months post stopping post
exposure prophylaxis e.g. at 4 months. However, this makes follow-up difficult, since the
patient is usually asked to return for HCV testing at 3 and 6 months. It would be acceptable
to test for HIV at the same intervals e.g. at 3 months instead of 4 months providing the
patient is informed about primary HIV infection symptoms and one is reasonably sure that
the patient will keep their 6 month follow-up appointment.
If a patient presents with clinical symptoms suggestive of HIV infection or AIDS and the HIV
screening tests are repeatedly negative, then referral of the specimen to a specialist testing
laboratory with experience in HIV confirmation of such cases is recommended (IV, C). There
is a theoretical risk that a patient with a diverse HIV-1 strain not belonging to the M-group will
not be detected by the current HIV screening tests. This possibility should be kept in mind
should the patient have had exposure in or from someone from Central and West Africa and
have a low CD4 count or AIDS defining illnesses.
It is recommended that the health care provider advises repeat HIV testing at least annually
to all persons who tested HIV negative but who are likely to be at high risk for HIV (CDC,
2006b). Persons likely to be at high risk include injection-drug users and their sex partners,
persons who exchange sex for money or drugs, sex partners of HIV-infected persons, and
men who have sex with men or heterosexual persons who themselves or whose sex partners
have had more than one sex partner since their most recent HIV test. Health-care providers
should also encourage patients and their prospective sex partners to be tested before
initiating a new sexual relationship (CDC, 2006b). Patients who are retested repeatedly
following subsequent sexual exposures should have more intensive counselling to establish
the reason and solution for their repeated risk. They should be made aware of the availability
of post exposure prophylaxis. (IV, C)
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patients are understandably anxious following the initial positive test and therefore it is
important that the confirmatory testing algorithm has an acceptable turnaround time. It should
be kept in mind that any weak positive results which are sent to a reference laboratory will
take a substantially longer turnaround time and the patient should be made aware of this.
Although the overall prevalence of HIV-2 infection is low in Europe and is mostly found in
individuals who have had exposure in or with someone from West Africa or the former
African Portuguese colonies, it is important that HIV confirmatory testing distinguish between
HIV-1 and HIV-2 infections. Since the viral load assays and treatment need to be tailored for
people with HIV-2 infections, the final laboratory HIV report, which usually contains at least
three test results, must clearly indicate whether the patient has an HIV-1 or HIV-2 or dual
confirmed infection. The health care provider should also be aware if the referral laboratory is
not able to distinguish between HIV-1 and HIV-2 infections.
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positive then a diagnosis of seroconversion can be made without further testing.
Alternatively, the initial specimen can be tested using a separate HIV-1 p24 antigen test with
neutralization or a NAAT test to diagnose early seroconversion. Remember all results should
still be confirmed on a follow-up specimen.
As suggested earlier, for all POCTs it is recommended that in case of a reactive result
(strong or weak) blood is drawn and sent to the laboratory for further testing.
In cases where the initial screening test cannot be confirmed with either the first or second
confirmatory test, a result of “indeterminate” should be given and a second blood sample
should be requested. The general recommendation is to separate the first and second blood
sample by at least 2 weeks (Rogstad, 2006), but in practice a rise in anti-HIV antibody titres,
as reflected in EIA signal strength (optical density/cut-off) or number of bands on the LIA/WB,
is dramatic over days during seroconversion. In most instances a good laboratory should be
able to distinguish a false reactive signal from seroconversion using two specimens spaced
one week apart as it is unfair towards an anxious patient to insist on waiting for two weeks.
There are no clear patterns of antibody reactivity that predict a higher likelihood of
seroconversion in patients with indeterminate WB results (Davey, 1992).
It is recommended that a plasma sample be used for the second sample so that NAAT
testing can be performed should it still be uncertain whether the patient is HIV infected
without the need to ask for another sample. Thus NAAT or HIV-1 viral load tests can be use
to diagnose HIV infections when the indeterminate and unconfirmed HIV test results occur
since they are positive 7-10 days before the routine HIV screening tests during
seroconversion and the HIV RNA levels are usually very high by the time anti-HIV antibodies
start to appear. However, as described earlier, both false-positive and false-negative HIV-1
viral load test results occasionally occur and thus care should be taken during interpretation.
In cases where the initial signal observed in the screening test does not increase in strength
over a 1-2 week period and where the signal is not caused by HIV-1 p24 antigen the result of
testing should be reported as non-specific. A second or third sample should be sent to a
reference laboratory for further testing which most likely will involve NAAT testing should
there be any doubt as to whether the reaction is non-specific.
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Recommendations:
HIV testing should be undertaken only with the individual’s specific informed verbal
consent which should be documented. (IV, C)
If a patient declines or defers HIV testing, this decision should be documented in the
medical record. (IV, C)
Pre-test discussion is the most appropriate way to obtain informed consent. The patient
should understand the purpose, risks and benefits of being tested and of not being tested,
and must give informed consent voluntarily. (IV, C)
Provision of an information leaflet about HIV testing can provide or replace much of the
information needed prior to obtaining informed consent. (III, B)
Patients identified as being at high risk for HIV or those with particular concerns should be
offered more in depth pre-test discussion. (IV, C)
The individual who declines or defers HIV testing on grounds related to confidentiality can
be offered anonymous testing. (IV, C)
During HIV testing in European STI/GUM settings informed consent, counselling and
confidentiality must be clearly observed (IV, C). The best way to ensure this is by pre-test
discussion (IV, C). The pre-test discussion is a recently introduced term which replaced the
term pre-test counselling which has been used in the past to describe a person needing to
see a professional with specific training and expertise in relation to HIV and/or counselling
prior to undertaking an HIV test (Rogstad, 2006). The main purpose of pre-test discussion is
to establish informed consent for the HIV test. The patient should understand the purpose,
risks and benefits of being tested and of not being tested, and must give informed consent
voluntarily (Rogstad, 2006) (IV, C).
Informed consent
Except for unlinked anonymous surveillance or rare cases described below, patients should
only be tested for HIV infection with their informed consent (IV, C). Informed consent must be
obtained before an HIV test is performed and should always be given individually, in private,
and in the presence of a health care provider (WHO, 2007). If a patient declines or defers
HIV testing, this decision should be documented in the medical record (IV, C). Declining an
HIV test should not result in reduced quality or denial of services that do not depend on
knowledge of HIV status (WHO, 2007) (IV, C).
Verbal communication is sufficient for the purpose of obtaining informed consent thus
policies that require consent to be given in writing are encouraged to be reviewed (WHO,
2007) (IV, C). Verbal consent should be always documented in the medical record (IV, C).
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It is recommended that a part of information required to be given prior to informed consent
(see below) be prepared in the form of an information leaflet that everybody should receive
(Rogstdad, 2003) (III, B). However, it remains essential to ensure that the individual
understands the information given on the information leaflet and that consent to testing is
obtained (Rogstdad, 2006). The information leaflet should be prepared in an easy to
understand informative way and translated in the various languages of the commonly
encountered populations within the service area (CDC, 2006b) (IV, C).
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where appropriate to explore support and coping mechanisms of receiving a positive
result;
obtaining informed consent for the test;
information about HIV transmission and risk reduction if necessary (e.g. knowledge of
condom use, including practical demonstration for both genders if needed);
an opportunity to ask the health care provider questions.
In addition to information listed above, pre-test discussion for women who are or may
become pregnant should include: the risks of transmitting HIV to the infant; measures that
can be taken to reduce mother-to-child transmission, including antiretroviral prophylaxis and
infant feeding counselling and the benefits to infants of early diagnosis of HIV infection
(WHO, 2007) (IV, C). For more details on pre-discussion for pregnant women consult recent
CDC guidelines (CDC, 2006a; CDC, 2006b).
Special considerations apply also in the case of adolescents who are below the legal age of
majority. The pre-test discussion should be adapted to the patient’s age, developmental
stage and literacy level (WHO, 2007). Since the legal framework, including the age of
consent for sexual intercourse and offering treatment services to adolescents, varies
between countries please consult relevant national guidelines e.g. in UK National guideline
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for the management of suspected sexually transmitted infections in children and young
people (Thomas, 2002). If national gudeline is not available you can consult recent
WHO/UNAIDS Guidance on provider-initiated testing and counselling in health facilities
(WHO, 2007).
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patient is unconscious and does not regain full consciousness within 48 hours, if patient
refuses testing, is unable to give or withhold consent because of mental illness or disability,
the health care provider can exceptionally, after reconsideration of the severity of risk,
arrange HIV testing without patient’s consent (Rogstad, 2006). In such cases the health care
provider may opt to test an existing blood sample, taken for other purposes, but consultation
with an experienced colleague should be sought first and he/she must be prepared to justify
that decision (Rogstad, 2006). If the health care provider decides to test without consent,
then he/she must inform the patient of his/her decision at the earliest opportunity. In such
cases confidentiality is paramount: only the patient and those who have been exposed to
infection may be told about the test and its result. In these exceptional circumstances neither
the fact that test has been undertaken, nor its result, should be entered in the patient's
personal medical record without the patient's consent (Rogstad, 2006).
For therapeutic options (post-exposure prophylaxis) after possible occupational exposure to
HIV please consult the recent review from Cochrane Library (Young, 2007).
Confidentiality
As a general rule, in pre-test discussion patients should be informed that their confidentiality
will be respected and protected including confidentiality of positive results (Thorvaldsen,
2001, Rogstad, 2006). However, patients should also be advised that confidentiality is not
absolute and that health care provider may be legally bound to disclose HIV status
information in exceptional circumstances (Rogstad, 2006). It is recommended that this
information is included in the information leaflet if appropriate (IV, C). The individual who
declines or defers HIV testing on grounds related to confidentiality can be offered
anonymous testing (Thorvaldsen, 2001) (IV, C).
Recommendations:
Detailed procedures how the patient will receive the result, with particular attention to the
means by which a positive result will be delivered should be established. (IV,C)
Arrangements for communicating the results should be discussed and agreed with the
patient at the time of testing. (IV, C)
Strict confidentiality of the receipt of the HIV test and the HIV test result must be
maintained, regardless of the method used. (IV, C)
Face-to-face post-test discussion is the preferred method of providing patients with their
results, but some patients might prefer an alternative method of receiving their result, such
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as SMS texting or a mailed report. (IV, C)
Post-test discussion for individuals with positive or inconclusive test results should be
always done face-to-face. (IV, C)
Stress to patients the importance of returning to receive their test results and establish a
plan for doing so. (IV, C)
Every effort should be made to trace positive patients who are not attending for results.
(IV, C)
All patients should be advised to disclose their HIV infection status to their regular sexual
and needle sharing partners. (IV, C)
Post-test discussion is an opportune time to re-enforce the issue of safer sex practices.
(IV, C)
Post-test counselling used to be an integral part of HIV testing. However, recent initiatives in
United Kingdom to expand testing to all individuals in HIV high prevalence health care
settings (Depart. of Health, 2007; Hamill, 2007) and the approach adopted in USA recently,
which involves HIV diagnostic testing and opt-out HIV screening as part of routine clinical
care, have put less emphasis on post-test discussion (CDC, 2006b). In the broader sense it
is a step in the right direction to “normalise” HIV testing and to remove perceived barriers to
testing. The CDC advises that HIV test results should be provided in the same manner as
results of other diagnostic or screening tests (CDC, 2006b). They do, however, make a
distinction between HIV diagnostic screening to detect HIV infection earlier and HIV
counselling and testing conducted primarily as a prevention intervention for uninfected
persons at high risk, like patients in STI/GUM settings (CDC, 2006b).
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telephone, SMS text or written results is an good option to low risk patients providing that the
clinic has a standard operating procedure (SOP) in place to deal with all possible scenarios,
including indeterminate and positive results. Patients should be informed that if they receive
a letter, SMS text or telephone call to come back to the testing site to discuss their results
that they must realise that this is to discuss indeterminate and unconfirmed results in the
majority of cases. However, the importance of returning to discuss their test results and a
plan for doing so should be established (IV, C). Alternatively, low-risk patients can simply be
informed that they will only be contacted if their test was reactive (indeterminate,
unconfirmed or positive).
It is preferable to have a written letter signed by the responsible health care provider, rather
than a copy of the actual result, and this should be addressed to a specific individual, not ‘to
whom it may concern’ if patients request or require written confirmation of their results
(Rogstad, 2006) (IV, C). A written protocol is recommended to set out the criteria for those
who receive results in this way, and how this is done (Rogstad, 2006) (IV, C).
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the possibility of an indeterminate test result, which usually turns out to be a non-specific
reaction. They should therefore not be completely uninformed at this stage, but the
significance and the further steps should be re-explained in a straightforward manner. The
importance of continual follow-up until the inconclusive result is resolved and the use of
condoms should be stressed.
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who will then be contacted by the clinic who will need to inform the contacts of an HIV
exposure whilst trying not to disclose the index patient’s details (IV, C).
Recommendations:
Recipients of preventive HIV vaccines might have vaccine-induced antibodies that are
detectable by HIV screening tests. Those individuals should be encouraged to contact or
return to their trial site or an associated trial site for the confirmatory testing necessary to
determine their HIV status. (IV, C)
HIV testing and counselling is recommended to all men seeking circumcision as an HIV
prevention intervention. (IV, C)
Due to illegal status of HIV self-tests in some European countries and several concerns
the use of such tests can not be recommended at present. (IV, C)
HIV self-testing
Self-testing for HIV is a procedure in which all stages of the HIV test take place in the
patient’s home (Frith, 2007). The patient obtains the sample, such as an oral-fluid swab, and
the result develops in 15-20 min. Self-tests for HIV need to be distinguished from home
27
sample-collection test kits in which the patient takes his/her own blood sample at home, then
sends it to a laboratory for testing and receives the results by telephone (Frith, 2007). Such
tests have had FDA approval since 1996. Due to illegal status of HIV self-tests in some
European countries and several concerns (accuracy, the nonability of people to provide
adequate samples for testing, possibility of abuse, lack of pre-test and post-test counselling)
the use of HIV self-test can not be recommended, at present (IV, C).
28
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