Dossier of evidence Why is it necessary to scale up HIV testing in Europe?

1. Dossier of evidenceWhy is it necessary to scale up HIV testing in Europe?

2. Content • Know your HIV epidemic – the situation of HIV in Europe • Late diagnosis of HIV infection • Characteristics of persons with late HIV diagnosis • Consequences of late diagnosis • Barriers to HIV testing • Overcoming barriers to HIV testing • Monitoring and evaluation • Conclusions

3. Know your HIV epidemicThe situation of HIV in Europe

4. Situation of HIV in EuropePeople living with HIV • In the WHO Europe region it is estimated that around 2.3 million people are living with HIV (end 2011) • Approaching 1 million in the European Union • 1.4 million in Eastern Europe and Central Asia • Of these 30-50% are unaware of their HIV infection...and even more in some countries • Key populations at higher risk of HIV in Europe are: • Men who have sex with men • Injecting drug users • Sex workers • Migrants • Prisoners Hamers FF & Phillips AN, Diagnosed and undiagnosed HIV-infected populations in Europe HIV Medicine (2008), 9 (Suppl. 2), 6–12 UNAIDS, Global report: UNAIDS report on the global epidemic 2012

5. Situation of HIV in EuropeAnnual number of new HIV cases European region 2006-2010 Stagnated HIV epidemic in Western and Central Europe, escalating HIV epidemic in Eastern Europe and Central Asia World Bank & WHO, HIV in the European Region, Policy Brief, 2013

6. Situation of HIV in EuropeHIV infections diagnosed in 2010 WHO European Region • In Western Europe the most common transmission mode for HIV is men who have sex with men (MSM) • Furthermore, despite a decrease in new infections in Western Europe, new 2013 data shows a rise in HIV incidence has occurred in MSM in some parts of Western Europe *No data from the following countries: Austria, Liechtenstein, Monaco. **Countries with no data on age or transmission mode excluded. ***Excludes individuals originating from countries with generalised epidemics. ECDC/WHO, HIV/AIDS Surveillance in Europe, 2010 Phillips AN, et al. Increased HIV Incidence in Men Who Have Sex with Men Despite High Levels of ART-Induced Viral Suppression: Analysis of an Extensively Documented Epidemic. PLoSONE, 2013

7. Situation of HIV in EuropeAIDS diagnoses 2004–2010WHO European Region ECDC/WHO, HIV/AIDS Surveillance in Europe, 2010

8. HIV Testing Guidelines • European HIV testing guidelines recommend: • 1. Making voluntary, confidential and free HIV testing available in a variety of settings: • Routine and universal offer to attendees of specified services: • STI clinics • Antenatal • Termination of pregnancy • Drug dependency services • Patients with clinical indicator disease attending a range of healthcare services (e.g. patients with tuberculosis, viral hepatitis and lymphoma) • Community testing sites/outreach targeted at key populations at higher risk at conveniently located testing sites and with the involvement of target populations • 2. Robust monitoring and evaluation World Health Organization. Scaling up HIV testing and counseling in the WHO European Region - as an essential component of efforts to achieve universal access to HIV prevention, treatment, care and support. Policy framework. 2010. Geneva: World Health Organization. World Health Organization. Guidance on provider-initiated HIV testing and counselling in health facilities. WC 503.1. 2007. Geneva: World Health Organization. .European Centre for Disease Prevention and Control. HIV testing: increasing uptake and effectiveness in the European Union. Stockholm: ECDC; 2010.

9. The HIV treatment continuum • Example from France, showing ART uptake, retention in care and treatment success 150,200 121,400 111,300 96,800 84,200 92% 51% 87% 87% Supervie et al. Presentation. HIV in Europe, March2012

10. Know your HIV epidemicTemplate slide for national data Populate this slide with the below: • Number of new diagnoses per year • Total number of people living with HIV (PLHIV) • PLHIV in need of treatment on ART • Key populations at higher risk of HIV • Geographical spread • Time trends • National HIV testing guidelines • Useful resources: • ECDC/WHO: HIV/AIDS surveillance in Europe 2011 (2012) • ECDC: HIV testing: increasing uptake and effectiveness in the European Union (2010) • WHO: Scaling up HIV testing and counselling in the WHO European Region (2010)

11. Late diagnosis of HIV infection

12. What does late diagnosis/ presentation for HIV care mean? • The expression late presentation is used when people are unaware of their HIV infection and not diagnosed until their CD4 count is below 350 cells/mL or have an AIDS-defining event, regardless of the CD4 cell count • The expression presentation with advanced HIV disease is used when people are diagnosed with a CD4 count below 200 cells/mL or an AIDS-defining event, regardless of the CD4 cell count European late presenter working group: Late presentation of HIV infection: A consensus definition, HIV Medicine 2010

13. Late diagnosis in Europe • In 21 countries across Europe (EU/EEA) with available data in 2011: • 49% of all HIV cases were diagnosed late (27-68%) • Including 29% with advanced HIV disease • In 7 countries across Europe (non-EU/EEA) with available data in 2011: • 62% of all HIV cases were late diagnosed (22-76%) • Including 38% with advanced HIV disease ECDC/WHO Europe, HIV/AIDS surveillance in Europe 2011. 2012

14. Late diagnosis in Europe • Although there has been a small downward trend over the years, data shows that very little has changed in terms of reducing late diagnosis Figure 1. Changes over time in late presentation and CD4 count at HIV diagnosis: COHERE 2000–2011. • MocroftA et al. Risk Factors and Outcomes for Late Presentation for HIV-Positive Persons in Europe: Results from the Collaboration of Observational HIV Epidemiological Research Europe Study (COHERE). PLoSMed, 2013

15. Late diagnosis in Europe • LP decreased over time in both Central and Northern Europe among homosexual men, and male and female heterosexuals, but increased over time for female heterosexuals and male intravenous drug users (IDUs) from Southern Europe and in male and female IDUs from Eastern Europe. • Late presenters had 6-13 fold excess risk of contracting AIDS or die within first year after diagnosis • Earlier and more widespread testing, timely referrals after testing positive, and improved retention in care strategies are required to further reduce the incidence of late diagnosis across Europe (and elsewhere) • MocroftA et al. Risk Factors and Outcomes for Late Presentation for HIV-Positive Persons in Europe: Results from the Collaboration of Observational HIV Epidemiological Research Europe Study (COHERE). PLoSMed, 2013

16. Late diagnosis of HIV infectionTemplate slide for national data Populate this slide with the below: • Percentages of new HIV cases who present with late diagnosis • Percentages of new HIV cases who present with advanced HIV infection • Useful resources: • ECDC/WHO: HIV/AIDS surveillance in Europe 2011 (2012)

17. Characteristics of persons with late HIV diagnosis

18. Characteristics of persons with late diagnosis • Across Europe the most common characteristics of persons with late diagnosis include: • migrant status • being older • being heterosexual (not in Eastern Europe) • living in low HIV prevalence areas • being male • having children ...but... Adler A, Mounier-Jack S & Coker J Late diagnosis of HIV in Europe: definitional and public health challengesAIDS Care 21, 03 (2009) 284-293.

19. Characteristics of persons with late diagnosis • Characteristics vary from country to country • The prevalence of late diagnosis in any given risk group will depend on a number of factors and vary between countries. These factors include the following… • Local trends in the incidence of infection • The perception of risk by individuals • The availability of testing programmes and access to these • Awareness in healthcare settings of HIV and the willingness to carry out an HIV test • Laws discriminating PLHIV and high-risk groups

20. Consequences of late diagnosis

21. Consequences of late diagnosis • Increased mortality and morbidity • Increased transmission of HIV to uninfected people • Increased economic burden for healthcare systems

22. Consequences of late diagnosisIncreased morbidity and mortality • Late diagnosis causes: • Increased risk of acquiring co-infections • Increased risk of treatment failure • Up to a third of all HIV-related deaths are estimated to be a consequence of late diagnosis Moreno S, Mocroft A & Monfonte A Review: Medical and Societal consequences of late presentation Antiviral Therapy, 2010, 15, suppl 1; 9-15. Adler A, Mounier-Jack S & Coker J. Late diagnosis of HIV in Europe: definitional and public health challenges AIDS Care 21, 03 (2009) 284-293.

23. Consequences of late diagnosisIncreased morbidity and mortality • Cumulative probability of death of people with HIV according to timing of diagnosis Nakawaga F et al. Projected life expectancy of people with HIV according to timing of diagnosis. AIDS 2011, 25.

24. Benefits of early diagnosis • Earlier HIV diagnosis is one of the most important factors associated with better life expectancy • The benefits of early HIV testing on morbidityand mortality: “With timely diagnosis, access to a variety of current drugs and good lifelong adherence, people with recently acquired infections can expect to have a life expectancy which is nearly the same as that of HIV negative individuals.” Nakagawa F, May M, Phillips A. Life expectancy living with HIV: recent estimates and future implications. Curr Opin Infect Dis. 2013 Feb;26(1):17-25. doi: 10.1097/QCO.0b013e32835ba6b1.

25. Consequences of late diagnosisIncreased transmission of HIV • Late HIV diagnosis contributes to the spread of the HIV epidemic because: • People on ART who are well-treated are less likely to transmit HIV onwards (a decline of 96% has so far been reported between early vs. delayed initiation of ART) • Evidence shows that people who know they are HIV positive decrease risk behaviour Moreno S, Mocroft A & Monfonte A Review: Medical and Societal consequences of late presentation Antiviral Therapy, 2010, 15, suppl 1; 9-15. Marks G, Crepaz N and Janssen RS, Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the US. AIDS 2006, 20:1447–1450. Hall HI et al. HIV Transmission Rates from persons living with HIV who are aware and unaware of their infection, United States AIDS 2012. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365:493–505.

26. Consequences of late diagnosisIncreased transmission of HIV • It is estimated that 54% of all new HIV infections derive from people who are not aware of their positive HIV status Accounting for: Unaware of infection Aware of infection Campsmith ML, Rhodes PH, Hall HI, Green TA. Undiagnosed HIV prevalence among adults and adolescents in the United States at the end of 2006. J Acquir Immune Defic Syndr. 2010;53:619-624. Marks G et al. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the US AIDS 2006, 20:1447–1450.

27. MSM in the UK The source of most new infections is from undiagnosed men • Observed increases in HIV incidence in last 10 years despite an increase in the precentage of MSM on fully suppressive ART • Increasing trends likely explained by more condom-less sexual behaviour • Source of new infections in 2010: • undiagnosed primary infection 48% • undiagnosed not primary infection 34% • diagnosed ART naive 10% • diagnosed ART experienced 7% • If testing frequency was increased to 68% of all MSM each year (compared with current rate of 25%), it is predicted that incidence would be reduced by 25% More testing = less new infections Phillips A et al. Increased HIV Incidence in Men Who Have Sex with Men Despite High Levels of ART-Induced Viral Suppression: Analysis of an Extensively Documented Epidemic. PLoS One 2013

28. Benefits of early diagnosisCost-effectiveness of HIV testing • Medical expenses for late diagnosis are up to 3.7 times as high as expenses for timely diagnosis and treatment • Even after 7 to 8 years, late diagnosis is still associated with higher cumulative expenses • Studies suggest that HIV testing remains cost-effective as long as the undiagnosed HIV prevalence is above 0.1% Krentz, HB & Gill MJ. Cost of medical care for HIV-infected patients within a regional population from 1997 to 2006. HIV Medicine (2008), 9, 721–730. Fleishman JA, Yehia BR, Moore RD, Gebo KA& HIV Research Network . The Economic Burden of Late Entry Into Medical Care for Patients With HIV Infection. Med Care. 2010 December ; 48(12): 1071–1079.

29. Benefits of early diagnosisCost-effectiveness of HIV testing Data from France showing HIV testing to be cost-effective when undiagnosed HIV prevalence is above 0.1% *QALY – quality of life years Base case * Direct method // 0% 1% 5% Undiagnosed HIV prevalence Yazdanpanah Y, et al. (2010) Routine HIV Screening in France: Clinical Impact and Cost-Effectiveness. PLoS ONE 5(10): e13132. doi:10.1371/journal.pone.0013132 http://www.plosone.org/article/info:doi/10.1371/journal.pone.0013132

30. Benefits of early diagnosisCost-effectiveness of HIV testing • Cost-effective threshold for expanded HIV testing in the US • 1 new HIV diagnosis/1,000 tested in general medical services3 • Shown to be cost-effective in: • US1: to test every 3 years costs $63,000 per QALY • France1: to test everyone once costs €56,000 per QALY • Absence of published data for Europe: • Expansion of HIV testing cost of £7,500 per QALY gained (RTI, Gilead Fellowship) - UK • No indication in which services HIV testing would be most cost-effective 1. Paltiel AD et at, N Engl J Med 2006/2005. 2. Yasdanpanah Y et al. Routine HIV Screening in France: Clinical Impact and Cost-Effectiveness. Plos One 2010. 3. MMWR 2006.

31. Benefits of early diagnosisSummary • Late presentation delays access to ART, adversely impacting on the health of the individual while also allowing inadvertent onward transmission The solution is more effective strategies to: • Test more effectively • Ensure better access to care for those diagnosed

32. Barriers to HIV testing

33. Barriers to HIV testing • Barriers to HIV testing exist on three levels • Patient level • Healthcare provider level • Institutional/policy level

34. Barriers to ask for HIV testingPatient level • Patient level barriers vary from country to country – but cross-cultural barriers include: • Low-risk perception • Fear of HIV infection and its health consequences • Fear of disclosure (worries about stigma, discrimination and rejection by significant others) • Denial • Difficulty accessing service, especially migrant populations Deblonde J et al. Barriers to HIV testing in Europe: a systematic review. European Journal of Public Health, 2010, Vol. 20, No. 4, 422–432.

35. Barriers to offer HIV testingHealthcare provider level • Healthcare provider level barriers to HIV testing: • Insufficient time • Burdensome consent process • Lack of knowledge/training • Pretest counselling requirements • Competing priorities • Inadequate reimbursement • Patient not perceived to be at risk • Leading to many missed opportunities for HIV testing within healthcare setting encounters Mounier-Jack Set al. HIV testing strategies across European countries. HIV Medicine (2008), 9 (Suppl. 2), 13–19. Sullivan AK, Raben D, Reekie J, Rayment M, Mocroft A, et al. (2013) Feasibility and effectiveness of indicator condition-guided testing for HIV: results from HIDES I (HIV Indicator Diseases across Europe Study). PLoS One 8: e52845. doi:10.1371/journal.pone.0052845. Partridge DG et al. HIV testing: the boundaries. A survey of HIV testing practices and barriers to more widespread testing in a British teaching hospital International Journal of STD & AIDS 2009; 20: 427-428.

36. Barriers to HIV testing Institutional/policy level • Barriers at institutional/policy level: • Lack of national policy/guidelines for HIV testing • A recent survey revealed that only half of European countries have national guidelines on HIV testing • Laws and justice systems that jeopardise HIV prevention efforts • Laws that criminalise PLHIV (for not disclosing, exposing and transmitting) • Laws that criminalise sex workers, injecting drug users and men having sex with men • Laws that do not protect PLHIV against discrimination Global Commission on HIV and the Law. HIV and the Law: Risks, Rights & Health. UNDP, HIV/AIDS Group, 2012.

37. Barriers to HIV testingLaws and policy system/enabling legal and social environments for MSM (men who have sex with men) World Bank & WHO, HIV in the European Region, Policy Brief, 2013

38. Barriers to HIV testingTemplate slide on country data Populate this slide with the below: • What are the barriers to asking for an HIV test (patient level)? • What are the barriers to offering an HIV test (healthcare provider level)? • What are the barriers at an institutional/policy level? • Are policy/guidelines for HIV testing implemented? • Are laws and justice system jeopardising HIV prevention efforts?

39. Overcoming barriers to HIV testing

40. Overcoming barriers Implementation of national HIV testing guidelines According to European guidelines scaling up of HIV testing should be done in compliance with core principles for an ethical approach based on human rights WHO has outlined 10 main principles for HIV testing, including detailed recommendations for endeavouring the scaling up of HIV testing Some of the principles are as follows…

41. Overcoming barriers Implementation of national HIV testing guidelines HIV test must be voluntary and confidential Expanded HIV testing must be tailored to different settings, populations and client needs Expanded HIV testing must expand beyond clinical settings and involve civil society organisations Provider-initiated testing in health facilities should be implemented when appropriate Efforts to increase access to HIV testing must be accompanied by efforts to ensure supportive social, policy and legal environments WHO/Europe. Scaling up HIV testing and counselling in the WHO European Region. 2010.

42. Overcoming barriersOutreach to populations at higher risk of HIV • Many populations at higher risk of HIV are in limited contact with the healthcare system • Special interventions designed to reach these groups are essential, e.g.: • Community based walk-in rapid HIV testing • Mobile clinics • Offer tests at needle and syringes programmes • Peer-led mobile outreach programme for sex workers • Must be offered in a non-judgmental manner • Peer-driven recommendation is advisable, i.e. awareness raising activities (to combat stigma and discrimination, to inform target groups on risk and risk behaviour, link to test and care) • WHO/Europe. Scaling up HIV testing and counselling in the WHO European Region, 2010.

43. Overcoming barriers Normalisation of HIV testing • Offer of HIV test acceptable to patients in many settings e.g. 83% acute medical patients • But tests often not offered, e.g. only 43% cases of tuberculosis tested for HIV • High variability between clinicians in offering HIV tests e.g. 45-88% among doctors • Missed opportunities for HIV testing • Opt-out (automatic) testing leads to increased testing rates, e.g. 96% for antenatal screening in UK in 2010 Ellis S et al. Clinical Medicine 2011; 11: 541-3. Thomas William S et al. Int J STD & AIDS 2011; 22: 748-50. Petlo T et al. Int J STD & AIDS 2011; 22: 727-9. National Antenatal Infections Screening Monitoring. HPA.

44. Approaches to testingcomplimentary testing is effective • Self referral • Healthcare facilities • Community based testing (check points) • Provider-initiated • All (non-targeted) • Subgroup (targeted) • Ethnicity, country of origin, sexual preference, etc • Type of condition presenting

45. Overcoming barriers Indicator Condition guided HIV testing • An approach by which healthcare professionals can be encouraged to test more patients based on suspicion of HIV • In healthcare settings where HIV testing is not part of standard medical care HIV testing should be offered routinely for certain clinical conditions • A number of diseases can indicate an undiagnosed HIV infection • It has been demonstrated that testing for these ‘indicator diseases’ will detect higher than average rates of HIV and is a cost-effective intervention • Useful resources: • HIV in Europe: HIV Indicator Conditions: Guidance for Implementing HIV Testing in Adults in Health Care Settings (2012) HIV in Europe. HIV Indicator Conditions: Guidance for implementing HIV testing in adults in Health Care Settings 2012.

46. Overcoming barriers Indicator condition guided HIV testing Feasibility and effectiveness • Indicator condition guided testing is an effective method of targeting HIV testing Sullivan et al. Feasibility and Effectiveness of Indicator Condition-Guided Testing for HIV: Results from HIDES I (HIV Indicator Diseases across Europe Study). PLOS ONE 2013.

48. Monitoring and evaluation

49. Monitoring and evaluation • Monitoring and evaluation (M&E) is an essential component of an HIV testing programme and ensures that the programme provides high quality HIV testing • FACTS criteria can be used when designing M&E: • Feasibility • Acceptability • Effectiveness and Cost-effectiveness • Target populations are reached • Sustainability ECDC, HIV testing: increasing uptake and effectiveness in the European Union, 2010.

50. Monitoring and evaluationExamples of indicators to assess local HIV testing initiatives using FACTS criteria ECDC, HIV testing: increasing uptake and effectiveness in the European Union, 2010.