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Int J STD AIDS 2009;20:77-83
doi:10.1258/ijsa.2008.008438
© 2009 Royal Society of Medicine Press

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Guideline

2008 European Guideline on HIV testing

M Poljak MD PhD * , E Smit MB FRCPath {dagger} and J Ross MD FRCP {ddagger}

* Faculty of Medicine, Institute of Microbiology and Immunology, University of Liubljana, Zatoska 4, 1000, Ljubljana, Slovenia; {dagger} Birmingham Heartlands and Solihull NHS Trust, Birmingham; {ddagger} Whitall Street Clinic, Birmingham, UK

Correspondence to: Professor Mario Poljak Email: mario.poljak{at}mf.uni-lj.si


    Summary
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Testing for HIV is one of the cornerstones in the combat against HIV infection. The 2008 European Guideline on HIV Testing provides advice on testing for HIV infection in individuals aged 16 years and older who have sought evaluation and treatment at sexually transmitted infection services for dermatovenereology clinics across Europe. Its aim is to provide practical guidance to clinicians in these settings who undertake HIV testing and suggest appropriate standards for the audit of service provision.

Key Words: HIV • AIDS • testing • guideline • Europe


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Testing for HIV is a procedure for the diagnosis or exclusion of HIV infection based on the detection of anti-HIV-specific antibodies and/or specific viral proteins and/or viral RNA/DNA in an individual, usually from a blood sample.

The guideline represents an updated version of the 2001 European Guideline for Testing for HIV Infection,1 approved by the European Office of International Union against Sexually Transmitted Infections (IUSTI) and European Office of the World Health Organization (WHO) with the incorporation of various new developments.

The main purpose of this guideline is to provide advice on testing for HIV infection in individuals aged 16 years and older who have sought evaluation and treatment in sexually transmitted infection (STI) services or dermatovenereology clinics across Europe (referred to as STI clinics). Its aim is to provide practical guidance to clinicians in these settings who undertake HIV testing and suggest appropriate standards for the audit of service provision. The guideline may also be applicable in other clinical settings where HIV testing is required depending on the characteristics of those attending, the nature of the health-care institution, and the social and epidemiological context. Decisions to follow this guideline must be based on the professional judgement of the clinician, consideration of individual patient circumstances and available resources.

Search strategy

Evidence for this guideline was provided by review of the Medline/Pubmed, Embase, Google, Cochrane Library and relevant guidelines up to February 2008. A Medline/Pubmed and Embase search was carried out from January 1981 to February 2008, looking for the following terms in the title or abstract: ’HIV testing‘, ’guideline(s)‘ and ’recommendation(s)‘; 19.783, 1.023 and 634 citations were identified, respectively. For some specific recommendations additional Medline/Pubmed search was performed when necessary. Google search was performed in November 2007 with the search term ’HIV testing guideline(s)‘ and all relevant documents of the first 150 search results were reviewed. A search of the Cochrane Library included Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and Cochrane Central Register of Controlled Trials. As mentioned earlier, 2001 European Guideline of Testing for HIV Infection were the main source for the present guidelines.1 In addition, the following guidelines and reports were reviewed in detail: 2006 UK National Guidelines on HIV Testing,2 2006 UK National Screening and Testing Guideline on STIs,3 a draft of the 2008 Guidelines for HIV Testing produced by the British Association for Sexual Health and HIV (BASHH), British HIV Association (BHIVA) and British Infection Society (BIS) and all recent HIV testing guidelines produced by the US Centers for Disease Control (CDC)46 and WHO/UNAIDS.7,8

The system used to grade the evidence and guidance recommendations is that published by the US Department of Health and Human Services Agency for Healthcare Research and Quality (www.ahrq.gov) (Appendix 1). These are indicated in bold type throughout the text, e.g. (Ia, A).


    GOALS OF HIV TESTING IN STI CLINICS
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 GOALS OF HIV TESTING...
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The primary goals of HIV testing in STI clinics are:


    BENEFITS AND HARMS OF HIV TESTING
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There are several important benefits from early self-knowledge of HIV infection, but there may also be some adverse effects.9 Knowing the diagnosis of HIV infection early, and thus being able to start highly active antiretroviral treatment (HAART) before the onset of severe immunosuppression, has been shown to dramatically improve the life-expectancy of the individual.10,11 (IIa, B) HAART is also an important contributor in decreasing the risk of HIV transmission by reducing the viral burden and therefore infectivity of infected individuals.12 (IIa, B) There is also consensus that it is best to start HAART before the onset of severe immunosuppression indicating the need for testing asymptomatic, high-risk individuals including those attending STI clinics.10 (IIb) Current treatment guidelines may leave a period of up to several years between diagnosis of HIV infection and starting HAART. In this period however, behaviour change resulting from knowledge of HIV status may reduce high-risk behaviour, which will be influenced by partnership status, prevailing community norms, serostatus disclosure, psychosocial and medical care services available to the individual and other factors.9 A meta-analysis of 27 reports published from 1985–1997 suggested no significant impact of HIV testing and counselling on sexual risk behaviour.13 Recent studies, following the introduction of HAART show an ambiguous picture. On one hand, individuals diagnosed with HIV infection significantly reduce sexual and needle-sharing risk behaviours, especially with uninfected partners, to whom they have disclosed their HIV status.1420 (Ia, A) On the other hand, individuals diagnosed with HIV may increase sexual risk behaviour, especially with casual HIV seroconcordant or assumed seroconcordant partners, because the main incentive for condom use – avoidance of HIV infection – does not apply anymore.9 Communication of HIV serostatus and disclosure in the setting of casual partnerships may frequently be non-explicit and selective. In addition, unprotected sex with HIV-infected seroconcordant casual partners is associated with increased risks for other STI-like syphilis and lymphogranuloma venereum.21,22


    WHEN TO CONSIDER HIV TESTING IN STI CLINICS
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Due to limited resources, a particular STI clinic may not be able to comply with the recommendation to offer the test to all individuals who seek evaluation and treatment. In these circumstances, priority for HIV testing should be given to the following individuals who are at higher risk of HIV infection (IV, C):1,3


    PRETEST ASSESSMENT
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The HIV pretest assessment should be pragmatic and client-centred. The main purpose of pretest assessment is to obtain informed consent prior to the HIV test.

Recommended components of pretest assessment

Provision of an information leaflet about HIV testing can provide or replace much of the information needed prior to obtaining informed consent, and is effective in many settings.23 (III, B). The information leaflet should be prepared in an easy to understand and informative way, and be available in the various languages commonly encountered in populations within the service area.6

Individuals who may require more in-depth pretest discussion

In addition to information and topics mentioned above, a more in-depth pretest discussion should be available for those requiring or requesting it or to those at high risk of a positive result. Individuals who may require more in-depth pretest discussion include:2

Additional assessment for women who are, or may become, pregnant should include:For more details on HIV in pregnant women consult relevant national guidelines or, if not available, the CDC (www.cdc.gov/hiv) or BHIVA guidelines (www.bhiva.org).5,6

Special considerations apply also in the case of adolescents in STI clinics who are below the legal age of consent. The pretest discussion should be adapted to the patient's age, developmental stage and literacy level.7 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. If a national guideline is not available, advice is available from recent WHO/UNAIDS Guidance on provider-initiated testing and counselling in health facilities.7

Testing without informed consent

HIV testing without informed consent is not recommended. In all cases where HIV testing is performed without informed consent, the health-care provider must be able to justify their actions and must take into consideration national legal and regulatory frameworks, guidance from national professional bodies and consensus opinion.2

Confidentiality

Individuals undergoing HIV testing should be informed that being tested, and their test result will usually remain confidential.1,2 However, individuals should also be advised that confidentiality is not absolute and that health-care providers may be legally bound to disclose HIV status information in exceptional circumstances.2 It is recommended that this information is included in an information leaflet where possible (IV, C). The use of a number or false name may be an option in some clinics for individuals who decline HIV testing due to concerns about confidentiality1 (IV, C).


    TESTING FOR HIV
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 TESTING FOR HIV
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Type of test

Confirmation of positive results

Quality control


    INTERPRETING HIV TEST RESULTS
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Health-care providers who order HIV tests should be familiar with basic laboratory terminology such as sensitivity, specificity, negative and positive predictive value of tests. This is not only helpful to interpret the test results correctly, but also to give an unambiguous answer to the patient during post-test discussion. The health-care provider should be especially aware of:

Interpreting negative HIV test results

Interpreting positive HIV test results

Interpreting indeterminate and unconfirmed HIV test results

HIV screening tests occasionally produce indeterminate or weakly reactive results that usually do not prove to be consistent with HIV infection.


    POST-TEST ISSUES
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Fortunately, the majority of HIV tests performed in STI clinics are negative. However, when the individual receives their result it provides an opportunity to encourage future safe sex behaviour.1

Post-test discussion for individuals who are negative

Post-test discussion for individuals with inconclusive test results

Post-test discussion for individuals who are positive

HIV-positive results should be given in a confidential environment and in a clear and direct manner.1 Patients are often very distressed when first informed about a positive HIV test result. They are faced with major adaptive challenges, such as accepting the possibility of a shortened lifespan, coping with other people's reactions to a stigmatizing illness, and with developing and adopting strategies for maintaining physical and emotional health.1,41 Appropriate support should be available on site or through referral to address the behavioural, psychosocial and medical implications of HIV infection.

The following issues should be covered:1

Experience has shown that even when the patient expected a positive result, there is still a powerful emotional reaction. Hence, it may be wise to postpone some of the information-giving to subsequent consultations:1Regarding the seropositive woman, there are some particular issues that should be included in the counselling at an early stage:1Following a positive HIV diagnosis, a newly diagnosed individual should be immediately referred to an appropriate specialist HIV treatment centre for further management and care. However, it should be stressed that after HIV diagnosis it is important to offer not only continuous monitoring of viral and immunological parameters for HIV infection, but also regular, comprehensive and easily accessible monitoring of other STIs and repeated sexual risk reduction counselling in a context of sympathetic, non-judgemental sexual history-taking.9

Non-attendance for positive results

Voluntary disclosure, partner notification and contact-tracing

Partner notification or partner referral is a cornerstone of STI programmes worldwide.45 The rationale for partner notification is that early diagnosis and treatment of HIV infection may significantly reduce morbidity and mortality, and provides the opportunity to reduce high-risk behaviour.1

Appropriate approaches to inform the partners of index patients are:1Partner notification is a challenge for any health-care system. Attitudes towards people at risk of being HIV-infected, social values, the ability to communicate and to what degree the patient has trust in the system are factors that are crucial to the success of any partner notification programme.1


    APPENDIX 1
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 APPENDIX 1
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LEVELS OF EVIDENCE AND GRADING OF RECOMMENDATIONS

Levels of evidence

Ia: Evidence obtained from meta-analysis of randomized controlled trials (RCTs);
Ib: Evidence obtained from at least one RCT;
IIa: Evidence obtained from at least one well-designed study without randomization;
IIb: Evidence obtained from at least one other type of well-designed quasi-experimental study;
III: Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case-control studies;
IV: Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities.

Grading of recommendations
A (Evidence levels Ia, Ib): Requires at least one RCT as part of the body of literature of overall good quality and consistency addressing the specific recommendation.

B (Evidence levels IIa, IIb, III): Requires availability of well-conducted clinical studies but no RCTs on the topic of recommendation.

C (Evidence IV): Requires evidence from expert committee reports or opinions and/or clinical experience of respected authorities. Indicates absence of directly applicable studies of good quality.


    ACKNOWLEDGEMENT
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 ACKNOWLEDGEMENT
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IUSTI/WHO European STD guidelines Editorial Board: Keith Radcliffe (Editor-in-Chief), Marita van de Laar, Michel Janier, Jorgen Skov Jensen, Martino Neumann, Raj Patel, Jonathan Ross, Willem van der Meijden, Pieter van Voorst Vader, Harald Moi.

Declarations of interest: MP – none; ES – Speakers fees and sponsorship to attend conferences from Abbott, Boehringer Ingelheim, Gilead, GSK, Roche, BMS and Tibotec. JR – Speakers fees, sponsorship to attend conferences and research grants from Abbott, Boehringer Ingelheim, Gilead, GSK, Roche, BMS, MSD and Tibotec.

(Accepted November 12, 2008)

    REFERENCES
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 REFERENCES
 

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