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UK NationalGuidelinesfor HIV Testing 2008UK NationalGuidelinesfor HIV Testing 2008UK Nat oi nal Gu di el ni es for H VI Test ni g 2008UK NationalGuidelinesfor HIV Testing 2008prepared jointly byBritish HIV AssociationBritish Association of Sexual Health and HIVBritish Infection SocietySeptember 2008www.bhiva.orgUK National Guidelinesfor HIV Testing 2008prepared jointly bySeptember 2008Standards For HIV CareBritish HIV Association iStandards For HIV CareiiBritish HIV Association · British Association for Sexual Health and HIV · British Infection SocietyUK National Guidelines for HIV Testing 2008All rights reserved. No part of this publication may be translated, reproduced, storedin a retrieval system or transmitted in any form by any means, electronic, mechanical,photocopying, recording, broadcasting or otherwise,without prior permission.© British HIV Association 2008First published September 2008UK National Guidelines for HIV Testing 2008iiiExecutive summary• HIV is now a treatable medical condition and the majority of those living with the virusremain fit and well on treatment.• Despite this a significant number of people in the United Kingdom are unaware of their HIVinfection and remain at risk to their own health and of passing their virus unwittingly on toothers.• Late diagnosis is the most important factor associated with HIV-related morbidity andmortality in the UK.• Patients should therefore be offered and encouraged to accept HIV testing in a wider rangeof settings than is currently the case.• Patients with specific indicator conditions should be routinely recommended to have an HIVtest.• All doctors, nurses and midwives should be able to obtain informed consent for an HIV testin the same way that they currently do for any other medical investigation.British Association for Sexual Health and HIV (BASHH) Adrian PalfreemanBritish HIV Association (BHIVA) Martin FisherBritish Infection Society (BIS) Ed OngCollege of Emergency Medicine James WardropeRoyal College of General Practitioners Ewen StewartRoyal College of Nursing Enrique Castro-SanchezRoyal College of Physicians Tim Peto, Karen RogstadRoyal College of Paediatrics and Child Heath Karen RogstadBritish Medical Association Julian SheatherDepartment of Health Expert Advisory Group on AIDS Brian Gazzard, Deenan PillayGeneral Medical Council Jane O’BrienHealth Protection Agency Valerie DelpechMedical Foundation for AIDS and Sexual Health (MedFASH) Ruth Lowbury, Russell FleetNational AIDS Trust Yusef AzadChildren’s HIV Association (CHIVA) Hermione LyallSociety of Sexual Health Advisors James HardieUK CAB Godwin AdegbiteBASHH Clinical Effectiveness Group Guy RooneyLay representative Richard WhiteheadWriting CommitteeUK National Guidelines for HIV Testing 2008ivUK National Guidelines for HIV Testing 2008v1Introduction ...................................................................................................................................................................... 12Background ........................................................................................................................................................................ 23Confidentiality and HIV testing ........................................................................................................ 44Recommendations for testing ............................................................................................................. 54.1 Who can test? .................................................................................................................................................. 54.2 Who should be offered a test? ......................................................................................................... 54.3 How often to test? ....................................................................................................................................... 64.4 Which test to use? ....................................................................................................................................... 85Pre-test discussion ................................................................................................................................................... 106Post-test discussion ................................................................................................................................................ 117Suspected primary HIV infection .................................................................................................... 13Appendix 1: Providing written confirmation of results ................................................. 14Appendix 2: Detailed post-test discussion and partner notification ............... 14Appendix 3: Community-based HIV testing ................................................................................ 14Appendix 4: Testing where the patient lacks capacity to consent .................... 15Appendix 5: Testing infants, children and young people ........................................... 16Appendix 6: The source patient in a needlestick injury orother HIV risk exposure .................................................................................................. 18Appendix 7: HIV testing and insurance ............................................................................................ 18Appendix 8: HIV testing and criminal prosecution for HIV transmission ... 18Appendix 9: Auditable standards ............................................................................................................ 19Acknowledgements .............................................................................................................................................. 20References ............................................................................................................................................................................ 21ContentsGuidelines for HIV TestingviUK National Guidelines for HIV Testing 20081These guidelines are intended to facilitate an increase in HIV testing in all healthcare settings asrecommended by the UK’s Chief Medical Officers and Chief Nursing Officers [1–4] in order to reduce theproportion of individuals with undiagnosed HIV infection, with the aim of benefiting both individual andpublic health. Misconceptions remain regarding HIV testing that hinder increased testing. In particular,many clinicians believe that lengthy pre-test counselling is required prior to testing. These guidelinesprovide the information needed to enable any clinician to perform an HIV test within good clinical practiceand encourage ’normalisation‘ of HIV testing.For this change in approach to be beneficial and ethically acceptable, it is imperative that following apositive HIV diagnosis, a newly diagnosed individual is immediately linked into appropriate HIV treatmentand care.This guidance refers to both diagnostic testing of individuals presenting with ‘clinical indicator diseases’(i.e. where HIV infection enters the differential diagnosis) and opportunistic screening of populations wherethis is indicated on the basis of prevalence data. We also include an appendix on the provision ofcommunity-based HIV testing (Appendix 3).It must be emphasised that in the UK, HIV testing remains voluntary and confidential. This is entirelypossible within any healthcare setting if these guidelines are followed.Introduction1Whilst the availability of highly active antiretroviral therapy (HAART) has transformed the outcome forindividuals with HIV infection, there continues to be significant and avoidable morbidity and mortalityrelating to HIV infection in the UK. A national audit by the British HIV Association (BHIVA) showed that ofdeaths occurring amongst HIV-positive adults in the UK in 2006, 24 per cent were directly attributable tothe diagnosis of HIV being made too late for effective treatment [5]. Furthermore, it has been shown thatmany of these ‘late presenters’ have been seen in the recent past by healthcare professionals without thediagnosis having been made [6]. National surveillance data shows that approximately one-third of all HIVinfections in adults in the UK remain undiagnosed [7] and that approximately 25 per cent of newlydiagnosed individuals have a CD4 cell count of less than 200 (an accepted marker of ‘late’ diagnosis).Late diagnosis of HIV infection has been associated with increased mortality and morbidity [7], impairedresponse to HAART [8] and increased cost to healthcare services [9]. Furthermore, from a public healthperspective, knowledge of HIV status is associated with a reduction in risk behaviour [10] and therefore itis anticipated that earlier diagnosis will result in reduced onward transmission [11]. Modelling hassuggested that over 50 per cent of new infections in the US occur through transmission from individualsin whom HIV has not been diagnosed. Furthermore, modelling in the US has also suggested that routinescreening for HIV infection is cost effective and comparable to costs of other routinely offered screeningwhere the prevalence of HIV exceeds 0.05 per cent [12].All the published literature suggests that uptake of testing is increased where universal routine (‘optout’) strategies have been adopted [13–15].Universal HIV (‘opt-out’) testing means that all individuals attending specified settings are offered andrecommended an HIV test as part of routine care but an individual has the option to refuse a test.Prior to 2001, HIV testing was largely confined to individuals presenting and requesting HIV testing inGUM clinics. The uptake of testing was low and a significant proportion of HIV-positive individuals wereknown to remain undiagnosed. The National Strategy for Sexual Health and HIV (2001) [16] recommendedthat all attendees at GUM clinics should be offered an HIV test with clear targets for the proportion offeredtesting and test uptake. Since this policy was introduced the proportion of infections which remainundiagnosed has reduced but still remains significant [25% in heterosexuals, 47% in men who have sexwith men (MSM)] [7]. The majority of GUM clinics now utilise a universal ‘opt-out’ approach to testing withhigh acceptability and success although the reasons why some high-risk individuals still refuse testingrequire further study.In the antenatal setting, prior to 2000, uptake of HIV testing was highly variable and dependent uponhealthcare worker factors rather than clinical need.The only randomised controlled trial published to date [13] on testing methods showed that a universal‘opt–out’ approach to HIV testing in antenatal patients was acceptable, did not cause anxiety and had ahigher uptake than other methods. Assessing patients for risk merely reduced the number of patientstested and it is recognised that women who refuse antenatal testing are more likely to be HIV positive.The adoption of universal opt-out testing [17] has resulted in a dramatic improvement in antenataltesting rates and a significant reduction in the proportion of HIV infections that remain undiagnosed priorto delivery, from 18 per cent in 2000 to fewer than 10 per cent in 2006 [7]. Furthermore the median CD4cell count at HIV diagnosis of women detected through antenatal screening has been consistently higherthan among other women (even after adjusting for age) and heterosexual men diagnosed with HIV. Thisindicates that efforts to detect HIV infection in asymptomatic individuals are likely to result in earlierdiagnosis, hence reducing morbidity and mortality in diagnosed individuals as well as reducing onwardtransmission [7].BackgroundUK National Guidelines for HIV Testing 200822UK National Guidelines for HIV Testing 20083In the USA in 2006 the Centers for Disease Control and Prevention (CDC) recommended opt-out testingfor all individuals aged 13 to 64 presenting to any healthcare facility (mainly Emergency Rooms) for anyreason [18]. Initial reports suggest that this has been successful in increasing the number of new HIVdiagnoses but barriers continue to exist including legal requirements in some states regarding testing, arequirement for written consent, and lack of access for some patients to ongoing HIV treatment andcare [19].In the UK, where the vast majority of patients have access to healthcare free at the point of delivery, allpatients have access to a general practitioner, and where there are pressures upon Emergency Departmentsto achieve four-hour waiting targets, we believe universal opt-out testing in all settings may not be themost feasible approach but support the use of opt-out testing in certain situations.HIV testing has historically been exceptionalised and treated differently to testing for other serious medicalconditions. The outlook for individuals testing positive for HIV is now better than for many other seriousillnesses for which clinicians routinely test. Whilst there remains stigma associated with HIV infection, thiscan be minimised by following the general principles of confidentiality for any medical condition as laiddown by the GMC in its guidance Confidentiality: protecting and providing information [20].’Patients have a right to expect that information about them will be held in confidence by their doctors.Confidentiality is central to trust between doctors and patients. Without assurances about confidentiality,patients may be reluctant to give doctors the information they need in order to provide good care.’The result of an HIV test (if positive) should be given directly by the testing clinician (or team) to thepatient and not via any third party, including relatives or other clinical teams unless the patient hasspecifically agreed to this (see section on post-test discussion).Confidentiality and HIV testingUK National Guidelines for HIV Testing 200843UK National Guidelines for HIV Testing 200854.1 Who can test?It should be within the competence of any doctor, midwife, nurse or trained healthcare worker to obtainconsent for and conduct an HIV test.4.2 Who should be offered a test?A. Universal HIV testing is recommended in all of the following settings:1. GUM or sexual health clinics2. antenatal services3. termination of pregnancy services4. drug dependency programmes5. healthcare services for those diagnosed with tuberculosis, hepatitis B, hepatitis C andlymphoma.B. An HIV test should be considered in the following settings where diagnosed HIV prevalencein the local population (PCT/LA) exceeds 2 in 1000 population (see local PCT data†):1. all men and women registering in general practice2. all general medical admissions.The introduction of universal HIV testing in these settings should be thoroughly evaluated for acceptabilityand feasibility and the resultant data made available to better inform the ongoing implementation of theseguidelines.C. HIV testing should be also routinely offered and recommended to the following patients:1. all patients presenting for healthcare where HIV, including primary HIV infection, enters thedifferential diagnosis (see table of indicator diseases and section on primary HIV infection)2. all patients diagnosed with a sexually transmitted infection3. all sexual partners of men and women known to be HIV positive4. all men who have disclosed sexual contact with other men5. all female sexual contacts of men who have sex with men6. all patients reporting a history of injecting drug use7. all men and women known to be from a country of high HIV prevalence (>1%*)8. all men and women who report sexual contact abroad or in the UK with individuals fromcountries of high HIV prevalence.** for an up to date list seehttp://www.unaids.org/en/KnowledgeCentre/HIVData/Epidemiology/latestEpiData.asp†Diagnosed prevalence is a good indicator of the undiagnosed prevalence in a population (ratio 2:1). All PCTs are routinely informedof the diagnosed prevalence rate by the Health Protection Agency (HPA) Survey of Prevalent HIV Diagnoses (SOPHID) data on anannual basis (further information on SOPHID data and its dissemination is available athttp://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1201767906579).A diagnosed prevalence exceeding 2 in 1000, in those aged between 15 and 59, is a proxy for an undiagnosed prevalenceexceeding 1 in 1000, the threshold at which routine testing is assumed to be cost effective based on the US data [18].Recommendations for testing4D. HIV testing should also be routinely performed in the following groups in accordance withexisting Department of Health guidance:1. blood donors2. dialysis patients3. organ transplant donors and recipients.4.3. How often to test?Repeat testing should be provided for the following groups:1. all individuals who have tested HIV negative but where a possible exposure has occurred withinthe window period2. men who have sex with men (MSM) – annually or more frequently if clinical symptoms aresuggestive of seroconversion or ongoing high risk exposure3. injecting drug users – annually or more frequently if clinical symptoms are suggestive ofseroconversion (see section on primary HIV infection)4. antenatal care – women who refuse an HIV test at booking should be re-offered a test, andshould they decline again a third offer of a test should be made at 36 weeks. Women presentingto services for the first time in labour should be offered a point of care test (POCT).A POCT test may also be considered for the infant of a woman who refuses testing antenatally.In areas of higher seroprevalence, or where there are other risk factors, women who are HIV negativeat booking may be offered a routine second test at 34–36 weeks’ gestation as recommended in the BHIVApregnancy guidelines [21].UK National Guidelines for HIV Testing 20086UK National Guidelines for HIV Testing 20087Table 1: Clinical indicator diseases for adult HIV infectionAIDS-defining conditions Other conditions where HIV testing should beofferedRespiratory Tuberculosis Bacterial pneumoniaPneumocystis AspergillosisNeurology Cerebral toxoplasmosis Aseptic meningitis/encephalitisPrimary cerebral lymphoma Cerebral abscessCryptococcal meningitis Space occupying lesion of unknown causeProgressive multifocal Guillain–Barré syndromeleucoencephalopathy Transverse myelitisPeripheral neuropathyDementiaLeucoencephalopathyDermatology Kaposi’s sarcoma Severe or recalcitrant seborrhoeic dermatitisSevere or recalcitrant psoriasisMultidermatomal or recurrent herpes zosterGastroenterology Persistent cryptosporidiosis Oral candidiasisOral hairy leukoplakiaChronic diarrhoea of unknown causeWeight loss of unknown causeSalmonella, shigella or campylobacterHepatitis B infectionHepatitis C infectionOncology Non-Hodgkin’s lymphoma Anal cancer or anal intraepithelial dysplasiaLung cancerSeminomaHead and neck cancerHodgkin’s lymphomaCastleman’s diseaseGynaecology Cervical cancer Vaginal intraepithelial neoplasiaCervical intraepithelial neoplasia Grade 2 or aboveHaematology Any unexplained blood dyscrasia including:• thrombocytopenia• neutropenia• lymphopeniaOphthalmology Cytomegalovirus retinitis Infective retinal diseases including herpesvirusesand toxoplasmaAny unexplained retinopathyENT Lymphadenopathy of unknown causeChronic parotitisLymphoepithelial parotid cystsOther Mononucleosis-like syndrome (primary HIVinfection)Pyrexia of unknown originAny lymphadenopathy of unknown causeAny sexually transmitted infectionTable 2: Clinical indicator diseases for paediatric HIV infectionAIDS-defining conditions Other conditions where HIV testing should beconsideredENT Chronic parotitisRecurrent and/or troublesome ear infectionsOral Recurrent oral candidiasisPoor dental hygieneRespiratory Pneumocystis Recurrent bacterial pneumoniaCMV pneumonitis Lymphoid interstitial pneumonitisTuberculosis BronchiectasisNeurology HIV encephalopathy Developmental delaymeningitis/encephalitis Childhood strokeDermatology Kaposi’s sarcoma Severe or recalcitrant dermatitisMultidermatomal or recurrent herpes zosterRecurrent fungal infectionsExtensive warts or molluscum contagiosumGastroenterology Wasting syndrome Unexplained persistent hepatosplenomegalyPersistent cryptosporidiosis Hepatitis B infectionHepatitis C infectionOncology LymphomaKaposi’s sarcomaHaematology Any unexplained blood dyscrasia including:• thrombocytopenia• neutropenia• lymphopeniaOphthalmology Cytomegalovirus retinitis Any unexplained retinopathyOther Recurrent bacterial infections(e.g. meningitis, sepsis,osteomyelitis, pneumonia etc.)Pyrexia of unknown origin4.4 Which test to use?There are two methods in routine practice for testing for HIV involving either venepuncture and a screeningassay where blood is sent to a laboratory for testing or a rapid point of care test (POCT).Blood testsThe recommended first-line assay is one which tests for HIV antibody AND p24 antigen simultaneously.These are termed fourth generation assays, and have the advantage of reducing the time betweeninfection and testing HIV positive to one month which is one to two weeks earlier than with sensitive thirdgeneration (antibody only detection) assays [22]. It is reasonable to expect universal provision of theseassays, although they are not offered by all primary screening laboratories.HIV RNA quantitative assays (viral load tests) are not recommended as screening assays because of thepossibility of false positive results, and also only marginal advantage over fourth generation assays fordetecting primary infection.UK National Guidelines for HIV Testing 20088UK National Guidelines for HIV Testing 20089Confirmatory assaysLaboratories undertaking screening tests should be able to confirm antibody and antigen/RNA. There is arequirement for three independent assays, able to distinguish HIV-1 from HIV-2. These tests could beprovided within the primary testing laboratory, or by a referral laboratory. All new HIV diagnoses should bemade following appropriate confirmatory assays and testing a second sample.Testing including confirmation should follow the standards laid out by the Health ProtectionAgency [23].Point of care testing (POCT)Point of care tests offer the advantage of a result from either a fingerprick or mouth swab sample withinminutes. They have advantages of ease of use when venepuncture is not possible, e.g. outside conventionalhealthcare settings and where a delay in obtaining a result is a disadvantage, but these must be weighedagainst the disadvantages of a test which has reduced specificity and reduced sensitivity versus currentfourth generation laboratory tests. Due to the low specificity of POCT and therefore the resulting poorpositive predictive value all positive results must be confirmed by serological tests as there will be falsepositives, particularly in lower prevalence environments. Only CE-marked POCT kits should be used and anominated accredited pathology laboratory should assist with governance issues and quality assurance ofthe testing process.POCT is therefore recommended in the following contexts (see BASHH Point of Care TestingGuidance) [24]:1. clinical settings where a rapid turnaround of testing results is desirable2. community testing sites3. urgent source testing in cases of exposure incidents4. circumstances in which venepuncture is refused.General laboratory issuesAll laboratories undertaking any diagnostic HIV services should be able to demonstrate satisfactory externalquality control data for the tests undertaken, and should have full accreditation status [23] [such as clinicalpathology accreditation (CPA)].All laboratories must have satisfactory HIV diagnosis confirmatory assay systems available to allow timelydefinitive diagnoses. This may involve referring samples to specialist virology laboratories, if appropriate, oreven national reference laboratories.All acute healthcare settings should expect to have access to an urgent HIV screening assay result ideallywithin eight hours, and definitely within 24 hours, to provide optimal support for exposure incidents.Routine opt-out test results should be expected to be available within 72 hours.The primary purpose of pre-test discussion is to establish informed consent for HIV testing. Lengthy pre-testHIV counselling is not a requirement, unless a patient requests or needs this [1–4].The essential elements that the pre-test discussion should cover are:• the benefits of testing to the individual• details of how the result will be given.This approach has been successful in GU and antenatal clinics and is generally acceptable.For some patients raising the issue of HIV testing in other scenarios might require more explanation asto why the doctor or nurse is recommending this, for example when a patient presents with a conditionwhich is more common in HIV infection.As with any other medical investigation the discussion should address any other issues which may beraised by the patient as it is important that patients are given the opportunity to make a decision withadequate information about the test and the virus.If a patient refuses a test the reasons why they have made that choice should be explored to ensure thatthese are not due to incorrect beliefs about the virus or the consequences of testing. If implications foreither insurance or criminal prosecution for transmission are raised by the individual as reasons for nottesting these should be further explored and any factual inaccuracies corrected (see Appendices 6 and 7).Some patients may need additional help to make a decision, for example, because English is not theirfirst language. It is essential to ensure that these patients have understood what is proposed, and why. Itis also important to establish that the patient understands what a positive and a negative result mean interms of infection with HIV as some patients could interpret ’positive‘ as good news.Children and young people, and those with learning difficulties or mental health problems, may needadditional support and time to understand what is proposed and to make a decision (see Appendices 3and 4).As with any other investigation the offer of an HIV test should be documented in the patient’s caserecord together with any relevant discussion. If the patient refuses a test the reasons for this should bedocumented. Usually, written consent is unnecessary and may discourage HIV testing by exceptionalising it.This advice is consistent with the GMC Guidance Consent: patients and doctors making decisionstogether [25].Pre-test discussionUK National Guidelines for HIV Testing 2008105UK National Guidelines for HIV Testing 200811As with any medical investigation it is essential that clear procedures are established as to how the patientwill receive the result, with particular attention paid to the means by which a positive result will bedelivered.Arrangements for communicating the results should always be discussed and agreed with the patientat the time of testing, particularly if the test is being performed in an outpatient or emergency care setting.Face-to-face provision of HIV test results is strongly encouraged for:• ward-based patients• patients more likely to have an HIV-positive result• those with mental health issues or risk of suicide• those for whom English is a second language• young people under 16 years• those who may be highly anxious or vulnerable.Post-test discussion for individuals who test HIV negativeIt is considered good practice to offer health promotion screening for sexually transmitted infections andadvice around risk reduction or behaviour change including discussion relating to post-exposureprophylaxis (PEP) to those individuals at higher risk of repeat exposure to HIV infection. This is best achievedby onward referral to GUM or HIV services or voluntary sector agencies.The need for a repeat HIV test if still within the window period after a specific exposure should bediscussed. Although fourth generation tests shorten the time from exposure to seroconversion a repeat testat three months is still recommended to definitively exclude HIV infection.Occasionally HIV results are reported as reactive or equivocal. These patients may be seroconverting (seesection on primary HIV infection) and management of re-testing may be complex and so such individualsshould be promptly referred to specialist care.Post-test discussion for individuals who test HIV positiveAs is good clinical practice for any situation where bad news is being conveyed, the result should be givenface to face in a confidential environment and in a clear and direct manner. If a patient’s first language isnot English, consideration should be given to utilisation of an appropriate confidential translation service.If a positive result is being given by a non-GUM/HIV specialist, it is essential, prior to giving the result,to have clarified knowledge of local specialist services and have established a clear pathway for onwardreferral.It is recommended that any individual testing HIV positive for the first time is seen by a specialist (HIVclinician, specialist nurse or sexual health advisor or voluntary sector counsellor) at the earliest possibleopportunity, preferably within 48 hours and certainly within two weeks of receiving the result [26].More detailed post-test discussion (including assessment of disease stage, consideration of treatment,and partner notification) will be performed by the GUM/HIV specialist team.Post-test discussion6Non-attendance for positive resultsIt is recommended to have an agreed recall process following failure of a patient to return for a positiveresult as with any other medical condition.As with all other medical investigations it is the responsibility of the healthcare professional requestingthe test to ensure that all results of investigations requested are received and acted upon where necessary.If there is no means of contacting the patient or if attempts are unsuccessful, it is recommended thatadvice be sought from the local GUM/HIV team who are likely to have experience and resources to dealwith this issue.UK National Guidelines for HIV Testing 200812UK National Guidelines for HIV Testing 200813Primary HIV infection (PHI) or seroconversion illness occurs in approximately 80 per cent of individuals,typically two-to-four weeks after infection. It is well recognised that this represents a unique opportunityto prevent onward transmission as an individual is considerably more infectious at this stage. Furthermorethis may be the only clinical opportunity to detect HIV before advanced immunosuppression many yearslater.It is known that the features of PHI are non-specific, that individuals usually do present to medicalservices (primary or emergency care) but frequently the diagnosis is missed or not suspected.The typical symptoms include a combination of any of:• fever• rash (maculopapular)• myalgia• pharyngitis• headache/aseptic meningitis.These resolve spontaneously within two-to-three weeks and therefore if PHI is suspected, this needs to beinvestigated at the time of presentation and not deferred.It is recommended that consideration be given to HIV testing in any person with these symptomsperceived to be at risk of infection. It is acknowledged that in some non-GUM settings details of anindividual’s sexual risk may be difficult to ascertain, but a low threshold for offering a test should remain.Although with fourth generation tests infection can be detected much earlier than previously(see section on primary screening assays), in very recent infection – when patients may be mostsymptomatic – the test may be negative. In this scenario, if PHI is suspected, either urgent referral tospecialist services (GU clinic or HIV service) or a repeat test in seven days is recommended. HIV viral loadtesting can be used in this clinical setting, but it is recommended that this is only performed with specialistinput.Suspected primary HIV infection7Appendix 1: Providing written confirmation of resultsThere may be occasions when patients request or require written confirmation of their results.A written protocol is recommended to set out criteria for those who receive results in this way and howthis is done.Clinicians who are not personally acquainted with the patient requesting such a letter should considerreferring the patient back to their general practitioner.If the patient requests a letter confirming their HIV status then ensure that they are correctly identifiedboth at the time blood is taken and when the result is given, by documenting the method of identificationsuch as photographic ID (e.g. passport, driving licence) in both the notes and the correspondence.It is preferable to have a written letter signed by the doctor (or another appropriate healthcareprofessional), rather than a copy of the actual result, and this should be addressed to a specific individual,not ‘To whom it may concern’.Appendix 2: Detailed post-test discussion and partnernotificationThe following issues would normally be dealt with when the patient is seen at the HIV clinic.Post-test discussion for individuals who test HIV positive provides an opportunity to address anyimmediate concerns and to look at the individual’s support and information needs.It is good practice to check if the patient has any immediate medical problems. In case of any symptomsan immediate link with a doctor or nurse may be indicated.It is again good practice to offer follow-up appointments (including testing where relevant) and ongoingsupport for the patient, partner or family where appropriate, although this may be done by specialistGUM/HIV services.Consideration should be given to discussion of partner notification. This will be dependent on theindividual but services should have clear guidelines on partner notification in HIV, how it is offered,including offering clients the option of provider referral.Issues such as preventing the onward transmission of HIV and the medico-legal issues surrounding this,as well as post-exposure prophylaxis for current or future partners who may be at risk, should also bediscussed.Appendix 3: Community-based HIV testingHistorically, HIV testing has been performed almost exclusively in medical settings. More recently,programmes have been explored to evaluate testing in community settings. Such programmesacknowledge that many individuals may prefer to test in non-medical settings, may not be registered withprimary care, may feel stigmatised by attending medical settings and being targeted for HIV testing, andmay not be prepared to disclose risk behaviour, including sexual orientation, to healthcare professionals.The ability to perform community-based testing has been largely enabled by the development of newertechnologies for HIV testing, particularly POCT (see section on point of care testing).AppendicesUK National Guidelines for HIV Testing 200814UK National Guidelines for HIV Testing 200815Pilot studies have shown that community-based testing is acceptable and feasible and may encouragepotentially high-risk individuals who would not otherwise have accessed HIV testing through conventionalservices [27]. The development of such services, complementary to expansion of existing healthcare-basedservices, should therefore be encouraged and evaluated, particularly in areas where there is a highprevalence of undiagnosed infection. It is vital to ensure that community testing services are linked to thelocal HIV clinic to ensure that patients will promptly and appropriately access care with clear referralpathways.Potential disadvantages to community testing include the limitations of the current POCT technologies,such that very recent infection may be missed, and the higher rates of ’false positive’ results compared toconventional laboratory-based testing. It is essential that anyone performing HIV testing in a nonhealthcare setting has adequate governance arrangements including quality assurance.The false positive rate will particularly affect individuals whose risk of HIV infection is low, and thereforeit is recommended that such programmes are targeted toward communities where undiagnosed HIVprevalence is high, particularly MSM and immigrant communities.If individuals report high-risk activity within the ‘window period’ of POCTs (currently 12 weeks), eitherrepeat testing in 12 weeks or attendance at a local healthcare HIV testing site should be encouraged.Individuals who test negative for HIV but who are at risk of other sexually transmitted infections(particularly MSM) should be encouraged to attend local GUM services for testing for other infection andto ensure adequate immunisation against hepatitis viruses.Appendix 4: Testing where the patient lacks capacity to consent(including the unconscious patient)Legislation in England, Wales and Scotland provides a framework for decision-making on behalf of adultsaged 16 and over who lack capacity to make decisions on their own behalf. The Mental Capacity Act 2005applies to England and Wales. In Scotland the Adults with Incapacity (Scotland) Act 2000 applies, for whichthere is a separate BMA guidance note. In Northern Ireland common law applies.A person lacks capacity if, at the time the decision needs to be made, he or she is unable to make adecision because of a mental disorder, or is unable to communicate their decision. Key points to considerwhen assessing capacity:1. The assessment of capacity relates to the specific issue in question – in this case consent to HIVtesting.2. Start from the presumption that the patient has capacity to make this decision.3. Consider whether the patient understands what decision they are being asked to make and canweigh up the information relevant to the decision; do they understand the consequences ofmaking a choice?4. Take all possible steps to help patients make a decision for themselves (e.g. provide informationin a more accessible form – drawings, tapes etc.). If you judge that a patient lacks capacity toconsent to an HIV test you should consider whether this is temporary or permanent. If temporary,you should defer testing until the patient regains capacity, unless testing is immediately necessaryto save the patient’s life or prevent a serious deterioration of their condition.If the lack of capacity is, or is likely to be, permanent you should seek a decision from any person withrelevant powers of attorney or follow the requirements of any valid advance statements. If the patient hasnot appointed an attorney nor left a valid advance statement, HIV testing may be undertaken where thisis in the best interests of the patient (England and Wales) or is necessary and of benefit to the patient(Scotland).Guidance on assessing capacity is published by the BMA [28–30]. Advice on how to assess appropriatetreatment of patients who lack capacity is available in the in the relevant statutory codes of practice forEngland [31] and Scotland [32].If consciousness is regained the patient should be told of the test result as soon as practicable.If they die, a decision should be made on disclosure according to the circumstances, e.g. others at riskand previously disclosed wishes.Appendix 5: Testing infants, children and young peopleAny infant/child/young person thought to be at significant risk of HIV infection, including all those withparents or siblings who are HIV-infected, should be tested. It is in the best interest of theinfant/child/young person to be tested in these circumstances although this only needs to be undertakenurgently in infants who are at risk of rapid disease progression.Who to consider for HIV testing• infants and children whatever their age where the mother has HIV, or may have died of anHIV-associated condition• infants born to mothers known to have HIV in pregnancy• infants born to mothers who have refused an HIV test in pregnancy• infants and children who are presented for fostering/adoption where there is any risk ofblood-borne infections [33]• infants and children newly arrived in the UK from high-prevalence areas (they may beunaccompanied minors)• infants and children with signs and symptoms consistent with an HIV diagnosis• infants and children being screened for a congenital immunodeficiency• infants and children in circumstances of post-exposure prophylaxis [34]• infants and children in cases where there has been sexual abuse (see below).Obtaining consent for HIV testing from childrenIn England and Wales, children are defined as those under 18 years old (Children Act 1989) and in Scotlandas under 16 [Children (Scotland) Act 1995].Under English law young people aged 16 years or over are assumed to have the capacity to consent tomedical treatment and should be treated in the same way as adults.Young people under 16 years accessing sexual healthcare (which would include HIV testing as part ofa sexual health screen) without a parent or guardian should be assessed for competency to consent [35].Testing in a non-competent childIf a child lacks the capacity to consent, then the consent of one parent or carer with parental responsibilityis sufficient. If you are aware of parental disagreement, refer to GMC guidance [36].Refusal of testing by a competent young personThis is a difficult area and varies according to country in the UK.In Scotland, parents cannot override a refusal to test by a competent young person.In England, Wales and Northern Ireland, the law on parents overriding a competent young person’srefusal to testing is complex. Legal advice should be sought about whether to apply to the court if testingis thought to be in the best interests of a competent child who refuses.UK National Guidelines for HIV Testing 200816UK National Guidelines for HIV Testing 200817Refusal of testing by parents of a non-competent child or young personIf parents refuse testing that is clearly in the best interests of a non-competent child or young person thenyou should consider involving other members of the multidisciplinary team, an independent advocate ornamed/designated doctor for child protection before seeking legal advice. This also applies if both a youngperson with capacity and their parents refuse testing.Testing victims of child sexual abuseTesting of victims of child sexual abuse should be considered in every case according to risk factors [36].Testing should always be performed if post-exposure prophylaxis is to be given. Where parental consent isrefused, refer to consent section of RCPCH guidelines on physical signs of child sexual abuse [37].Testing of children of known HIV-positive parentsTesting should be offered in all cases at risk of vertical transmission. Increasing evidence shows that childreninfected vertically can survive into teenage years without being diagnosed. Therefore, it can not beassumed that older children of mothers with HIV do not require testing. This raises difficult issues ofinformed consent for these young people, particularly if they are unaware of the mother’s diagnosis.Testing of neonates, children and young people where the mother refuses consent and/or disclosure ofher HIV status is a complex area. The overriding consideration must be the best interests of the child, andmultidisciplinary decision-making and expert advice should be sought, including legal advice whereappropriate. It is not acceptable to simply accept a mother’s refusal. Referral to a paediatric centre withexperience of management of HIV-infected children is strongly recommended.Parents may need to be supported in making the decision to go ahead to test their children; paediatricHIV support is available nationally through the Children’s HIV National Network (CHINN), details of whichcan be found on the Children’s HIV Association (CHIVA) website, www.chiva.org.uk.What do children need to know about having an HIV test?One of the main reasons that parents do not want to test their children for HIV is because they are afraidto share the diagnosis with them. It should be explained to parents that a developmentally andage-appropriate explanation of the test should be given to children and that this does not necessarily meanusing the term HIV.1) Older children (usually those older than 11) should be asked to give consent for an HIV test.2) Younger children (usually five to ten years of age) can be told they are being tested for a ‘bug’ inthe blood.3) Pre-school children and infants do not need any formal explanation of why they are having ablood test.Appropriate HIV tests for infants and childrenChildren older than 18 months of age: HIV antibody test, as for adults.Infants younger than 18 months of age: infants born to mothers with HIV receive transplacental maternalHIV antibodies which can usually be detected in the infant blood until about 18 months of age. Infants aretherefore tested for genomic evidence of HIV by PCR. For details see BHIVA guidelines on the managementof HIV in pregnancy [21].Appendix 6: The source patient in a needlestick injury or otherHIV risk exposureThe Human Tissue Act (2004) which governs the obtaining of source patient consent supersedes previousGMC guidance.The source patient’s consent to testing must always be gained. Consent from the patient should beobtained from a healthcare worker other than that who sustained the injury. If the rationale for testing isexplained, it is unusual for consent to be refused. If the patient does not wish to know the result the optionof testing without any documentation should be considered.For guidance on testing a source patient from a needlestick injury who is unconscious or unable to giveconsent seek expert advice as the law on this is being reviewed. Guidance on post-exposure prophylaxisfor occupational exposure to HIV is published by the UK CMOs’ Expert Advisory Group on AIDS(EAGA) [38].Appendix 7: HIV testing and insuranceThe ABI code of practice 1994 states that questions regarding whether an individual has ever had an HIVtest or a negative result should not be asked. Applicants should however declare any positive results ifasked as would be the case with any other medical condition [39,40].Appendix 8: HIV testing and criminal prosecution for HIVtransmissionConcern about this issue should not be a barrier to testing. There have been a number of prosecutions ofindividuals under the Offences Against the Person Act 1861 for reckless HIV transmission. This has includeda prosecution of an individual who had not been HIV tested. There is detailed guidance on the legalimplications of this available from the voluntary sector as well as advice on safer sexual practices designedto minimise risk of transmission of HIV to others [41,42].UK National Guidelines for HIV Testing 200818UK National Guidelines for HIV Testing 200819Appendix 9: Auditable standardsStandard Audited by what data and How often ? Commentsby whom?Offer and uptake of HIV test GUMCAD; HPA Annually National report;in GUM local feedbackOffer and uptake in of HIV test National Antenatal Annually National report;in antenatal care Infections Screening local feedbackMonitoring programme(NAISM); HPAOffer and uptake of HIV test Sentinel unlinked anonymous Annually National reportin drug misuse services seroprevalence data, HPAOffer and uptake of HIV test in Local clinic data sources Annually National report;TOP services local team discussionProportion of HIV undiagnosed Sentinel unlinked anonymous Annually National report(by risk group) seroprevalence data, HPAProportion of newly diagnosed New diagnoses/SOPHID/ Annually National report;HIV positive with CD4 < 200 CD4 surveillance; HPA local feedbackProportion of newly diagnosed New diagnoses/SOPHID/ Annually National report;HIV positive with CD4 < 350 CD4 surveillance; HPA local feedbackNumber of HIV tests performed Local lab with GUM/HIV/ID Annually Local meeting with PCT ifin primary care input no increaseNumber of HIV tests Local lab with GUM/HIV/ID Annually Local meeting withperformed in secondary care input relevant teams if noincreaseProportion of individuals with Local data sources Annually Local team discussionindicator disease being tested (using IT or case note audits)for HIVOffer and uptake of HIV test Chest/ID clinic (using IT or Annually Joint meeting to discussamong TB patients case note audits)Offer and uptake of HIV test Oncology (using IT or case Annually Joint meeting to discussamong lymphoma patients note audits)Offer and uptake of HIV test Hepatology/ID/among hepatitis B and C gastroenterology (using IT Annually Joint meeting to discusspatients or case note audits)AcknowledgementsThe authors would like to thank all those listed below who responded to the consultation on theseguidelines, which attracted a great deal of constructive and helpful comment, much of which has beenincorporated into the final draft.It has not however been possible to accommodate all of the suggestions and advice received ascorrespondents were divided in their approach to some of the issues. We have therefore made all of thefeedback comment to the original consultation draft available on the BHIVA website, www.bhiva.org.UK National Guidelines for HIV Testing 200820The Terence Higgins TrustThe National Aids TrustHIV ScotlandSigma ResearchAfrican HIV Policy NetworkPositively WomenGMFAPOZFEMGeorge House TrustWaverley CareRoyal College of Paediatricsand Child HealthAssociation ofMedical MicrobiologistsChildren’s HIV AssociationProfessor Jackie CassellProfessor Sebastian LucasDr Alastair MillerDr Mary PoultonDr Andrew WinterDr C MitsidesDr Helen LaceyDr Ann SullivanDr John WhiteDr Clive TaylorDr Rudiger PittrofDr Frances SandersonDr John ParryRoger PebodyChristine HardwickBabs EvansGus CairnsHilary CurtisClaire BlackstockKevin MilesKavita DassMax CourtneyBev IbbetsonJanet Murat andSascha AuweilerUK National Guidelines for HIV Testing 200821References1. Sir Liam Donaldson, CMO & Christine Beasley, CNO. Improving the detection and diagnosis of HIV in non-HIVspecialties including primary care. 13 September 2007.http://www.info.doh.gov.uk/doh/embroadcast.nsf/vwDiscussionAll/EE0FA479BAA64A1B80257355003DFB472. Dr Harry Burns, CMO & Mr Paul Martin, CNO. Improving the detection and diagnosis of HIV in non-HIV specialtiesincluding primary care. CEL 15. Chief Medical Officer and Chief Nursing Officer Directorates, ScottishGovernment. 23 October 2007.3. Dr Tony Jewell, CMO & Rosemary Kennedy, CNO. Improving the detection and diagnosis of HIV in non-HIVspecialties including primary care. Department of Public Health and Health Professions, Welsh AssemblyGovernment. 30 October 2007.4. Dr Michael McBride, CMO and Mr Martin Bradley, CNO. Improving the detection and diagnosis of HIV in non-HIVspecialties including primary care. HSS(MD)23/2007. Department of Health, Social Services and Public Safety ofNorthern Ireland. 19 September 2007.5. British HIV Association (BHIVA). 2005–6 mortality audit.http://www.bhiva.org/files/file1001379.ppt6. Sullivan AK, Curtis H, Sabin CA et al. Newly diagnosed HIV infections: review in UK and Ireland. BMJ, 2005, 330,1301–2.http://www.bmj.com/cgi/content/full/330/7503/13017 Health Protection Agency (HPA), Centre for Infections. The UK Collaborative Group for HIV and STI Surveillance.Testing Times. HIV and other sexually transmitted infections in the United Kingdom: 2007.http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/12030843559418. Stöhr W, Dunn DT, Porter K et al. on behalf of the UK CHIC Study. CD4 cell count and initiation of antiretroviraltherapy: trends in seven UK centres, 1997–2003. HIV Medicine, 2007, 8, 135–41.9. Krentz HB, Auld MC, Gill MJ. The high cost of medical care for patients who present late (CD4<200 cells/μL) withHIV infection. HIV Medicine, 2004, 5, 93–8.10. Marks G, Crepaz N, Janssen RS. Estimating sexual transmission of HIV from persons aware and unaware that theyare infected with the virus in the USA. AIDS, 2006, 20, 1447–50.http://www.aidsonline.com/pt/re/aids/pdfhandler.00002030-200606260-00012.pdf;jsessionid=LHGYMBT176T4KKms5qv9ynYGtQp7QnkvWryzQbJFB9jfm7v7Zz3v!1629792715!181195629!8091!-111. Vernazza P, Hirschel B, Bernasconi E et al. Les personnes séropositives ne souffrant d’aucune autre MST et suivantun traitment antirétroviral efficace ne transmettent pas le VIH par voie sexuelle (An HIV-infected person onantiretroviral therapy with completely suppressed viraemia (“effective ART”) is not sexually infectious). Bulletindes Médecins Suisses, 2008, 89(5), 165–9.http://www.saez.ch/pdf_f/2008/2008-05/2008-05-089.PDF12. Sanders GD, Bayoumi AM, Sundaram V et al. Cost-Effectiveness of Screening for HIV in the Era of Highly ActiveAntiretroviral Therapy. New Engl J Med, 2005, 352, 570–85.13. Simpson WM, Johnstone FD, Boyd FM et al. Uptake and acceptability of antenatal HIV testing: randomisedcontrolled trial of different methods of offering the test. BMJ, 1998, 316, 262–7.14. Haukoos J, Hopkins E, Byyny R et al. and The Denver Emergency Department HIV Testing Study Group (2008).Opt-out Rapid HIV Screening in the Emergency Department: Preliminary Results from a Prospective Clinical Trial.CROI 2008, Abstr 544b.http://www.retroconference.org/2008/PDFs/544b.pdf15 Cohan D, Gomez E, Charlebois E. Patient Perspectives and Testing Uptake with Abbreviated versus Standard Pretest HIV Counseling in the Prenatal Setting: A Randomized-Controlled, Non-inferiority Trial. CROI 2008;Abstr 535a.http://www.retroconference.org/2008/PDFs/535a.pdf16. Department of Health (DH) (2001). Better prevention, better services, better sexual health – the national strategyfor sexual health and HIV.http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_400313317. Department of Health (2003). Screening for infectious diseases in pregnancy.http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_405093418. Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults,adolescents, and pregnant women in health-care settings. MMWR, 2006, 55/(RR14): 1–17.http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm19. Walensky RP, Losina E, Malatesta L et al. The high yield of routine HIV screening in urgent care sites inMassachusetts. CROI 2008, Abstr 39.http://www.retroconference.org/2003/cd/Abstract/39.htm20. General Medical Council (GMC) (2004). Confidentiality: protecting and providing information.http://www.gmc-uk.org/guidance/current/library/confidentiality.asp21. British HIV Association and Children’s HIV Association guidelines for the management of HIV infection inpregnant women 2008. HIV Medicine, 2008, 9, 452–502.http://www.bhiva.org/files/file1031055.pdf22. Barbara J, Ramskill S, Perry K et al. The National Blood Service (England). Approach to evaluation of kits fordetecting infectious agents. Transfusion Medicine Reviews, 2006, 21, 147–58.23. Health Protection Agency (2007). Anti-HIV screening – minimum testing algorithm. National Standard MethodVSOP 11(1).http://www.hpa-standardmethods.org.uk/documents/vsop/pdf/vsop11.pdf24. British Association for Sexual Health and HIV (BASHH) (2006). Clinical Governance Committee. Guidance on theappropriate use of HIV Point of Care Tests.http://www.bashh.org/committees/cgc/reports/final_hiv_point_of_care_tests_guidance_rev080606.pdf25. General Medical Council (2008). Consent: patients and doctors making decisions together.http://www.gmc-uk.org/news/index.asp#ConsentGuidance26. British HIV Association, Royal College of Physicians (RCP), British Association for Sexual Health and HIV, BritishInfection Society (BIS) (2007). Standards for HIV clinical care.http://www.bhiva.org/files/file1001299.pdf27. Weatherburn P, Hickson F, Reid D et al. Evaluation of the Department of Health funded fasTest HIV testing in thecommunity pilots. London: Sigma Research, 2006.www.sigmaresearch.org.uk/go.php/projects/project4228. British Medical Association. The Mental Capacity Act 2005 – Guidance for health professionals. London: BritishMedical Association, 2007.http://www.bma.org.uk/ap.nsf/Content/mencapact05?OpenDocument&Highlight=2,mental,capacity29. British Medical Association and Law Society. Assessment of mental capacity: guidance for doctors and lawyers:2nd edition. London: BMJ Publications, 2004.30. British Medical Association. Medical treatment for adults with incapacity: guidance on ethical and medico-legalissues in Scotland. London: British Medical Association, 2002.http://www.bma.org.uk/ap.nsf/Content/AdultsincapacitySC31. Department for Constitutional Affairs. Mental Capacity Act 2005 Code of Practice. London: TSO, 2007.http://www.dca.gov.uk/legal-policy/mental-capacity/mca-cp.pdf32. Scottish Government (2007). Revised codes of practice for the Adults with Incapacity Act.http://www.scotland.gov.uk/Topics/Justice/Civil/awi/revisedcodes33. Children's HIV Association of UK and Ireland (2007). HIV testing of children and young people.http://www.chiva.org.uk/protocols/testing.html34. Children's HIV Association of UK and Ireland (2007). Post-exposure prophylaxis (PEP) Guidelines for childrenexposed to blood-borne viruses.http://www.chiva.org.uk/protocols/pep.html35. General Medical Council (2007). 0–18 years: guidance for all doctors.http://www.gmc-uk.org/guidance/ethical_guidance/children_guidance/index.aspUK National Guidelines for HIV Testing 200822UK National Guidelines for HIV Testing 20082336. British Association for Sexual Health and HIV Clinical Effectiveness Group (2002). National guideline on themanagement of suspected sexually transmitted infections in children and young people.http://www.bashh.org/documents/41/41.pdf37. Royal College of Paediatrics and Child Health. The physical signs of child sexual abuse. An evidence-based reviewand guidance for best practice. Sudbury: Lavenham Press, 2008.38. Department of Health (2004). HIV post-exposure prophylaxis: guidance from the UK Chief Medical Officer’sExpert Advisory Group on AIDS.http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_408363839. Association of British Insurers (1994). ABI statement of practice – underwriting life insurance for HIV/AIDS.www.abi.org.uk/Display/File/Child/197/HIV_SoBP_1994.doc40. Association of British Insurers (2004). Statement of best practice on HIV and insurance.http://www.abi.org.uk/Display/File/86/HIV_SoBP_September_2004.doc41. Terrence Higgins Trust (THT) website section on criminal prosecution.www.tht.org.uk/informationresources/prosecutions/ accessed 23 July 2008.42. Anderson J, Chalmers J, Nelson M et al (2006). HIV transmission, the law and the work of the clinical team. Abriefing paper.http://www.bhiva.org/files/file1001327.pdfRegistered Charity No: 1056354UK Nat oi nal Gu di el ni es for H VI Test ni g 2008
来源网址：http://www.who.int/hiv/topics/vct/policy/uk_guidelines_hivtesting08.pdf
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