Knowledge and behaviours associated with HIV infection and other sexually transmitted infections in blood donors in Italy.

INTRODUCTION: Sexually transmitted infections (STIs) represent a group of widespread infectious diseases. The objective of this study is to investigate the knowledge on HIV and STIs as well as sexual risk behaviours among blood donors in Italy. MATERIALS AND METHODS: The study was carried out in 2017 among blood donors who accessed social media of the Italian Association of Blood Donors (Associazione Volontari Italiani del Sangue, AVIS), and answered to a questionnaire posted online. RESULTS: Participating blood donors were 9,021, median age 36 years (IQR 26-47), 53.9% males, 94.3% heterosexual, and 2.7% reported having a current occasional partner. Unprotected sex in the last 4 months was reported by 54.1% of participants. About half of the participants were not informed of most STIs, 11.0% reported never having searched for information on HIV and STIs, one third considered unlikely acquiring HIV through unprotected sex with a known person, 21.3% would stop having sex with a partner found to be HIV-positive, and 15.8% would be afraid to hug or kiss a person with HIV. DISCUSSION: Our results show that most blood donors have a stable partner and search actively for information on HIV and STIs. However, there is a proportion of them who engage in high-risk behaviours, have misconceptions on HIV and STIs transmission, reporting a stigmatising attitude towards people with HIV. CONCLUSION: A more comprehensive and updated information on various STIs, transmission modes and safe sex should be provided to blood donors, not only to prevent the spread of these infections but also to avoid unjustified discrimination.

Impact of COVID-19 epidemic on temporal pattern of new HIV diagnoses in Italy, 2021 database.

BACKGROUND: New HIV diagnoses in Italy decreased drastically in 2020 due to COVID-19 related effects: 50% fewer diagnoses were reported by the National HIV Surveillance System. COVID-19 pandemic impact on HIV surveillance is unclear. We estimated the expected number of new HIV diagnoses in 2020 in order to isolate the impact of the COVID-19 pandemic. METHODS: We analyzed 29 697 new HIV infections diagnosed from 2012 to 2020, reported to the National HIV Surveillance System. We assessed temporal trends of new HIV diagnoses applying negative binomial mixed effects models. We estimated the COVID-19 impact as the difference between the model-estimated slopes from 2012 to 2019 and the change reported in the diagnoses. The expected number of new HIV diagnoses in 2020 was also estimated and compared with the reported count. RESULTS: Based on the historical trend, we expected a 15% (95% CI: 5-25%) decline of new HIV diagnoses in 2020. We reported, however, a 49% decrease, yielding to a 34% net decrease in the number of new diagnoses. The strongest impact was estimated in northern regions (-40%) and MSM (-38%). We estimated 761 (95% prediction interval: 350-1277) missed diagnoses during 2020, the majority of them occurring in the North (465 cases), among MSM (416) and heterosexual males (217). CONCLUSIONS: In 2020, when excluding 15% decrease of new diagnoses attributable to the expected reduction, an additional 34% decrease was observed, representing a large decline in new HIV diagnoses associated with the COVID-19 pandemic.

Increased kidney disease mortality among people with AIDS versus the general population: a population-based cohort study in Italy, 2006-2018.

OBJECTIVES: This study aimed to assess whether an excess mortality related to kidney and other urinary tract diseases exists among Italian people with AIDS (PWA), as compared with the general population without AIDS (non-PWA). DESIGN: Population-based, retrospective cohort study. SETTING AND PARTICIPANTS: We conducted a nationwide study including 9481 Italian PWA, aged 15-74 years, reported to the National AIDS Registry between 2006 and 2018. METHODS: Vital status and causes of death were retrieved by record linkage with the National Register of Causes of Death up to 2018. Excess mortality for PWA versus non-PWA was estimated through sex-standardised and age-standardised mortality ratios (SMRs) with corresponding 95% CIs. RESULTS: Among 2613 deceased PWA, 262 (10.0%) reported at least one urinary tract disease at death, including 254 (9.7%) non-cancer diseases-mostly renal failures (225 cases, 8.6%)-and 9 cancers (0.3%). The overall SMR for non-cancer urinary tract diseases was 15.3 (95% CI 13.4 to 17.3) with statistically significant SMRs for acute (SMR=22.3, 95% CI 18.0 to 27.4), chronic (SMR=8.4, 95% CI 6.0 to 11.3), and unspecified renal failure (SMR=13.8, 95% CI 11.2 to 16.8). No statistically significant excess mortality was detected for urinary tract cancers (SMR=1.7, 95% CI 0.8 to 3.3). The SMRs were particularly elevated among PWA aged <50 years, injecting drug users, or those with the first HIV-positive test >6 months before AIDS diagnosis. CONCLUSIONS: The excess mortality related to non-cancer kidney and other urinary tract diseases reported among PWA highlights the importance of implementing the recommendation for screening, diagnosis and management of such conditions among this population.

Mortality of people with AIDS in Italy: comparison of AIDS surveillance and multiple cause-of-death registries.

AIMS: To assess whether the use of multiple cause-of-death data could improve reporting of AIDS mortality in Italy. METHOD: Population-based, record-linkage study, on 3,975,431 deaths recorded in the National Registry of Causes of Death (RCoD) and 4,530 deaths recorded in the National AIDS Registry (RAIDS), during 2006-2012. RESULTS: The record-linkage identified 3,646 AIDS-related deaths present in both registries, 884 deaths in the RAIDS without mention of HIV/AIDS in the RCoD, and 3,796 deaths in the RCoD with mention of HIV/AIDS that were not present in the RAIDS. In the latter, in-depth analysis of multiple cause-of-death allowed the identification of 1,484 deaths that were AIDS-related. On these results, we estimated 6,014 deceased people with AIDS. Of them, 14.7% (884) were not present in the RCoD and 24.7% (1,484) derived from the RCoD only. CONCLUSIONS: The integration of different nationwide registries allowed a more comprehensive estimate of the impact of AIDS-associated mortality in Italy.

Hemorheological profiles and chronic inflammation markers in transfusion-dependent and non-transfusion- dependent thalassemia.

The rheological properties of blood play an important role in regulating blood flow in micro and macro circulation. In thalassemia syndromes red blood cells exhibit altered hemodynamic properties that facilitate microcirculatory diseases: increased aggregation and reduced deformability, as well as a marked increase in adherence to the vascular endothelial cells. A personalized approach to treating thalassemia patients (transfusions, iron chelation, and splenectomy), has increased patients' life expectancy, however they generally present many complications and several studies have demonstrated the presence of high incidence of thromboembolic events. In this study the hemorheological profiles of thalassemia patients have been characterized to point out new indices of vascular impairment in thalassemia. Plasma viscosity, blood viscosities at low and high shear rates (η1 and η200, respectively), erythrocyte aggregation index (η1/η200), and the erythrocyte viscoelastic profile (elastic modulus G', and viscous modulus G") have been studied in transfusion-dependent and non-transfusion-dependent thalassemia patients. Moreover, the levels of inflammation biomarkers in thalassemia have been evaluated to investigate a relationship between the biomarkers, the disease severity and the rheological parameters. The biomarkers studied are the main components of the immune and endothelial systems or are related to vascular inflammation: cytokines (IL-2, IL-6, IL-10, IL-17A, TNF-alpha), chemokines (IL-8, MIP-1alpha), adipocytokines (leptin and adiponectin), growth factors (VEGF, angiopoietin-1), adhesion molecules (ICAM-1, VCAM-1, E-selectin, L-selectin), and a monocyte/macrophage activation marker (CD163). This study shows that transfusion-dependent thalassemia patients, both major and intermedia, have blood viscosities comparable to those of healthy subjects. Non-transfusion-dependent thalassemia intermedia patients show high blood viscosities at low shear rates (η1), corresponding to the flow conditions of the microcirculation, an increase in erythrocyte aggregation, and high values of the elastic G' and viscous G" modules that reflect a reduced erythrocyte deformability and an increase in blood viscosity. Levels of cytokines, chemokines and adhesion molecules are different in transfusion- and non-transfusion dependent patients and positive correlations between η1 or η1/η200 and the cytokines IL-6 and IL-10 have been observed. The evaluation of the hemorheological profiles in thalassemia can provide new indicators of vascular impairment and disease severity in thalassemia in order to prevent the onset of thromboembolic events.

Post-migration acquisition of HIV: Estimates from four European countries, 2007 to 2016.

BackgroundThe assumption that migrants acquire human immunodeficiency virus (HIV) before migration, particularly those from high prevalence areas, is common.AimWe assessed the place of HIV acquisition of migrants diagnosed in four European countries using surveillance data.MethodsUsing CD4+ T-cell count trajectories modelled to account for seroconversion bias, we estimated infection year of newly HIV-diagnosed migrants residing in the United Kingdom (UK), Belgium, Sweden and Italy with a known arrival year and CD4+ T-cell count at diagnosis. Multivariate analyses identified predictors for post-migration acquisition.ResultsBetween 2007 and 2016, migrants constituted 56% of people newly diagnosed with HIV in the UK, 62% in Belgium, 72% in Sweden and 29% in Italy. Of 23,595 migrants included, 60% were born in Africa and 70% acquired HIV heterosexually. An estimated 9,400 migrants (40%; interquartile range (IQR): 34-59) probably acquired HIV post-migration. This proportion was similar by risk group, sex and region of birth. Time since migration was a strong predictor of post-migration HIV acquisition: 91% (IQR: 87-95) among those arriving 10 or more years prior to diagnosis; 30% (IQR: 21-37) among those 1-5 years prior. Younger age at arrival was a predictor: 15-18 years (81%; IQR: 74-86), 19-25 years (53%; IQR: 45-63), 26-35 years (37%; IQR: 30-46) and 36 years and older (25%; IQR: 21-33).ConclusionsMigrants, regardless of origin, sex and exposure to HIV are at risk of acquiring HIV post-migration to Europe. Alongside accessible HIV testing, prevention activities must target migrant communities.

Demographic and socio-economic determinants of poor HIV-risk perception at first HIV diagnosis: analysis of the HIV Surveillance data, Italy 2010-2016.

INTRODUCTION: HIV infections in Italy has not undergone a substantial decline over recent years. For this reason, we analysed risk-factors and socio-economic indicators of HIV-risk perception in HIV surveillance data. METHODS: An observational study was conducted and HIV-risk perception was estimated on the basis of reasons for undergoing testing. Ordinal logistic models were applied with three groups of response corresponding to three ordered levels of HIV-risk perception. RESULTS: The study included 18 055 individuals: 27% with low, 40% moderate and 33% with high perception. A low risk perception was estimated in both areas, least deprived and highly deprived [Adjusted Odds Ratio (AOR) = 1.58, CI: 1.14-2.18 and AOR = 2.33, CI: 1.39-3.90]; for heterosexuals (AOR = 1.96, CI: 1.83-2.11), Injecting Drug Users (IDU) (AOR =1.82, CI: 1.59-2.08), low education (AOR = 1.74. CI: 1.20-2.54), age > 40 years (AOR = 1.59, CI: 1.50-1.69), males (AOR = 1.30, CI: 1.20-1.40). CONCLUSIONS: In Italy there is a high percentage of HIV-infected people with poor HIV-risk perception. Poorer HIV-risk perception was associated with both, least and high deprivation, low education, older age, male gender, heterosexual and IDU groups. Our results could be relevant to address targeted HIV testing policies at both local and national levels.

Estimated burden of Chlamydia trachomatis female infection and consequent severe pelvic inflammatory disease, Italy, 2005-2016.

Chlamydia trachomatis (Ct) is the leading sexually transmitted infection (STI) across Europe. In Italy, Ct prevalence is low in general population, but predominance of asymptomatic infections, passive voluntary reporting, variable diagnostic criteria and coding practices can lead to considerable underestimation, preventing assessment of real burden of disease and health intervention. We analysed data on female genital Ct infection registered in STI sentinel surveillance systems in Italy from 2005 through 2016 and found 3305 women. Among them, those aged 20-24 years had the highest disability-adjusted life years (DALYs) estimation equal to 106.77 DALYs per 100 000-stratum specific population. Through the study period, incidence rate (IR) for female Ct infection increased significantly from 2.9 to 7.1 per 100 000 resident population. Besides, we analysed data on pelvic inflammatory disease (PID) reported from the National Hospital Information system (NHIS) in the same period. We found 287 women hospitalised with concurrent PID and Ct infection. We recommend targeted screening programmes in women aged 20-24, definition of nationwide active surveillance system, standardisation of diagnostic criteria and ICD-9CM coding practices.

Allergy screening in a schoolchildren-based population.

BACKGROUND: Schoolchildren screening for allergic diseases may improve early identification and management of atopic children. The aim of this study was to perform a schoolchildren screening program for identification of children with allergic diseases. METHODS: All parents of children attending to 13 primary schools in the city of Rome were requested to fill in a demographic data form and the ChAt questionnaire. Allergological evaluation was performed in the children with suspect of allergy (ChAt score > 2). Ocular examination was performed to identify signs of allergic conjunctivitis. The presence of allergic symptoms was related to demographic and environmental variables. RESULTS: A total of 2667 children (mean age: 7.1 ± 1 years) were included, and 2489 (93.3%) parents completed the ChAt questionnaire. Results of ChAt questionnaire showed a previous diagnosis of allergic disease in 637 (25.6%) children and the potential presence of an allergic disease (ChAt score > 2) in 35.1%. Multivariate analysis showed that older age, male gender, and having less than two siblings were associated with higher risk of allergic disease. Visual screening showed the presence of clinical signs of allergic conjunctivitis in 2% of children. Allergologic evaluation in 334 children confirmed the diagnosis of allergic disease in 324 (97%) cases. Among them, 97 (29.9%) did not refer to a previous formal diagnosis of allergic condition. CONCLUSIONS: This study confirmed that schoolchildren screening using ChAt questionnaire could represent a useful tool for early identification of yet undiagnosed atopic children.

Excess mortality related to circulatory system diseases and diabetes mellitus among Italian AIDS patients vs. non-AIDS population: a population-based cohort study using the multiple causes-of-death approach.

BACKGROUND: Chronic diseases, chiefly cancers and circulatory system diseases (CSDs), have become the leading non-AIDS-related causes of death among HIV-infected people, as in the general population. After our previous report of an excess mortality for several non-AIDS-defining cancers, we now aim to assess whether people with AIDS (PWA) experience also an increased mortality for CSDs and diabetes mellitus (DM), as compared to the non-AIDS general population (non-PWA). METHODS: A nationwide, population-based, retrospective cohort study was conducted including 5285 Italians, aged 15-74 years, who were diagnosed with AIDS between 2006 and 2011. Multiple cause-of-death (MCoD) data, i.e. all conditions reported in death certificates, were retrieved through record-linkage with the National Register of Causes of Death up to 2011. Using MCoD data, sex- and age-standardized mortality ratios (SMRs) with 95% confidence intervals (CIs) were calculated by dividing the observed number of PWA reporting a specific disease among MCoD to the expected number, estimated on the basis of mortality rates (based on MCoD) of non-PWA. RESULTS: Among 1229 deceased PWA, CSDs were mentioned in 201 (16.4%) certificates and DM in 46 (3.7%) certificates among the various causes of death. These values corresponded to a 13-fold higher mortality related to CSDs (95% CI 10.8-14.4) and DM (95% CI: 9.5-17.4) as compared to 952,019 deceased non-PWA. Among CSDs, statistically significant excess mortality emerged for hypertension (23 deaths, SMR = 6.3, 95% CI: 4.0-9.4), ischemic heart diseases (39 deaths, SMR = 6.1, 95% CI: 4.4-8.4), other forms of heart diseases (88 deaths, SMR = 13.4, 95% CI: 10.8-16.5), and cerebrovascular diseases (42 deaths, SMR = 13.4, 95% CI: 9.7-18.2). The SMRs were particularly elevated among PWA aged < 50 years and those infected through drug injection. CONCLUSIONS: The use of MCoD data disclosed the fairly high mortality excess related to several CSDs and DM among Italian PWA as compared to non-PWA. Study findings also indicate to start preventive strategies for such diseases at a younger age among AIDS patients than in the general population and with focus on drug users.

[Regional HIV Surveillance in Italy: a starting point for the future national system]. / Le sorveglianze HIV regionali in Italia: la base per il futuro sistema nazionale.

BACKGROUND: the Italian National HIV Surveillance, instituted by the Ministerial Decree of March 31st, 2008, is based on 21 regional surveillance systems and adopts an essential data collection form with a definite data flow. The unification of HIV and AIDS surveillance systems and the implementation of an identical data collection form are priorities of the Italian National HIV/AIDS Action Plan 2017 (PNAIDS). OBJECTIVES: to describe the 21 regional HIV surveillance systems and to verify the feasibility of their unification. METHODS: in March 2017, a questionnaire containing 13 questions was sent to all the regional representatives of the 21 surveillance systems. The main questions were about timeliness, data flow, and quality of the system. The quality was measured through a subjective evaluation expressed by the regional referent through scores from 1 (minimum) to 10 (maximum) regarding four indicators (regional coverage, timeliness, correctness, and completeness of the data). RESULTS: more than half of the regional systems use a computerized data collection method. Some of these regions have not completely adapted to the data collection form contained in the Decree and other regions declare a undernotification of the system. The majority of the regions record a slight notification delay by the reporting centres. Some regions report gaps in the completeness of the data received by the reporting centres. CONCLUSIONS: the main strengths of the HIV surveillance system are computerization of the systems and slightly reporting delay. Regarding the quality of the regional systems and its data, the study reports a good self-evaluation. This study also showed useful indications to improve the national HIV surveillance system, such as the unification of HIV surveillance with the AIDS surveillance and the implementation of a unique national system, as suggested by guidelines of the PNAIDS 2017.

People living with undiagnosed HIV infection and a low CD4 count: estimates from surveillance data, Italy, 2012 to 2014.

Background and aimsLate HIV diagnosis is associated with onward HIV transmission, higher morbidity, mortality and healthcare costs. In Italy, more than half of people living with HIV were diagnosed late during the last decade, with a CD4 count < 350 cells/mm3 at diagnosis. We aimed to determine the number and characteristics of people living with undiagnosed HIV infection and low CD4 counts in Italy. Methods: Data on newly reported HIV diagnoses from 2012 -2014 were obtained from the national HIV surveillance system. We used the European Centre for Disease Prevention and Control HIV modelling tool to calculate the undiagnosed prevalence and yearly diagnosed fraction (YDF) in people with low CD4 count. Results: The estimated annual number undiagnosed HIV infections with low CD4 count was on average 6,028 (95% confidence interval (CI): 4,954-8,043) from 2012-2014. In 2014, most of the undiagnosed people with low CD4 count were men (82.8%), a third acquired HIV through sex between men (MSM) (35.0%), and heterosexual transmission (33.4%), respectively. The prevalence of undiagnosed HIV infection was 11.3 (95% CI: 9.3-14.9) per 100,000 residents ranging from 0.7 to 20.8 between Italian regions. Nationally the prevalence rate was 280.4 (95% CI: 173.3-450.2) per 100,000 MSM, 8.3 (95% CI: 4.9-13.6) per 100,000 heterosexual men, and 3.0 (95% CI: 1.4-5.6) per 100,000 women. The YDF was highest among heterosexual women (27.1%; 95% CI: 16.9-45.2%). Conclusions: These findings highlight the importance of improving efforts to identify undiagnosed HIV infections primarily among men, both MSM and heterosexual men.

HIV avidity index performance using a modified fourth-generation immunoassay to detect recent HIV infections.

BACKGROUND: Detecting recent HIV infections is important to evaluate incidence and monitor epidemic trends. We aimed to evaluate the diagnostic performance and accuracy of the avidity index (AI) for discriminating for recent HIV infections. METHODS: We collected serum samples from HIV-1 positive individuals: A) with known date of infection (midpoint in time between last HIV-negative and first HIV-positive test); B) infected for >1 year. Samples were divided into two aliquots: one diluted with phosphate buffered saline (PBS) and the other with 1 M guanidine. Both aliquots were assayed by the Architect HIV Ag/Ab Combo 4th generation assay (Abbott). We compared AI found in recent (RI=<6 months from seroconversion) and established (EI) infections. The diagnostic accuracy was evaluated by receiver operating characteristic (ROC) curve analysis. The proportion of samples misclassified as recent (FRR) was calculated. RESULTS: In total, 647 samples were collected: 455 in group A (51.6% RI and 48.4% EI) and 192 in group B. Among these, sixteen samples were from elite controllers, 294 from treated patients, 328 from patients infected with non-B subtypes. Samples before antiretroviral initiation showed a mean AI significantly lower among RI compared to EI (0.66+0.28 vs. 1.00±0.12; p<0.000). The FRR was 0% using a cut-off of ≤0.70. An extremely low FRR was observed among elite controllers, samples with low VL or CD4. HIV subtype had no impact on AI misclassifications. All individuals in group A reached the AI threshold of 0.80 within 24 months after seroconversion. CONCLUSIONS: The AI is an accurate serological marker for discriminating recent from established HIV infections and meets WHO requirements for HIV incidence assays.

Multiple cause-of-death data among people with AIDS in Italy: a nationwide cross-sectional study.

BACKGROUND: Multiple cause-of-death (MCOD) data allow analyzing the contribution to mortality of conditions reported on the death certificate that are not selected as the underlying cause of death. Using MCOD data, this study aimed to fully describe the cause-specific mortality of people with AIDS (PWA) compared to people without AIDS. METHODS: We conducted a nationwide investigation based on death certificates of 2,515 Italian PWA and 123,224 people without AIDS who had died between 2006 and 2010. The conditions most frequently associated with PWA mortality, compared to people without AIDS, were identified using an age-standardized proportion ratio (ASPR) calculated as the ratio between the age-standardized proportion of a specific cause among PWA and the same proportion among people without AIDS. RESULTS: The most frequently reported conditions at death among PWA were infectious/parasitic diseases (52%), digestive (36%), respiratory (33%), and circulatory (32%) system diseases, and neoplasms (29%). All AIDS-defining conditions resulted highly associated (ASPR significantly greater than unity) with PWA deaths. Significant associations also emerged for leishmaniasis (ASPR = 188.0), encephalitis/myelitis/encephalomyelitis (ASPR = 14.3), dementia (ASPR = 13.1), chronic viral hepatitis (ASPR = 13.1), liver fibrosis/cirrhosis (ASPR = 4.4), pneumonia (ASPR = 4.4), anal (ASPR = 12.1) and liver (ASPR = 1.9) cancers, and Hodgkin's disease (ASPR = 3.1). CONCLUSIONS: Study findings identified the contribution of several non-AIDS-defining conditions on PWA mortality, emphasizing the need of preventive public health interventions targeting this population.

Non-AIDS-Defining Cancer Mortality: Emerging Patterns in the Late HAART Era.

BACKGROUND: Non-AIDS-defining cancers (non-ADCs) have become the leading non-AIDS-related cause of death among people with HIV/AIDS. We aimed to quantify the excess risk of cancer-related deaths among Italian people with AIDS (PWA), as compared with people without AIDS (non-PWA). METHODS: A nationwide, population-based, retrospective cohort study was carried out among 5285 Italian PWA, aged 15-74 years, diagnosed between 2006 and 2011. Date of death and multiple-cause-of-death data were retrieved up to December 2011. Excess mortality, as compared with non-PWA, was estimated using sex- and age-standardized mortality ratios (SMRs) and the corresponding 95% confidence intervals (CIs). RESULTS: Among 1229 deceased PWA, 10.3% reported non-ADCs in the death certificate, including lung (3.1%), and liver (1.4%), cancers. A 7.3-fold (95% CI: 6.1 to 8.7) excess mortality was observed for all non-ADCs combined. Statistically significant SMRs emerged for specific non-ADCs, ie, anus (5 deaths, SMR = 227.6, 95% CI: 73.9 to 531.0), Hodgkin lymphoma (12 deaths, SMR = 122.0, 95% CI: 63.0 to 213.0), unspecified uterus (4 deaths, SMR = 52.5, 95% CI: 14.3 to 134.5), liver (17 deaths, SMR = 13.2, 95% CI: 7.7 to 21.1), skin melanoma (4 deaths, SMR = 10.9, 95% CI: 3.0 to 27.8), lung (38 deaths, SMR = 8.0, 95% CI: 5.7 to 11.0), head and neck (9 deaths, SMR = 7.8, 95% CI: 3.6 to 14.9), leukemia (5 deaths, SMR = 7.6, 95% CI: 2.4 to 17.7), and colon-rectum (10 deaths, SMR = 5.4, 95% CI: 2.6 to 10.0). SMRs for non-ADCs were particularly elevated among PWA infected through injecting drug use. CONCLUSION: This population-based study documented extremely elevated risks of death for non-ADCs among PWA. These findings stress the need of preventive interventions for both virus-related and non-virus-related cancers among HIV-infected individuals.

Bio-behavioural HIV and STI surveillance among men who have sex with men in Europe: the Sialon II protocols.

BACKGROUND: Globally, the HIV epidemic continues to represent a pressing public health issue in Europe and elsewhere. There is an emerging and progressively urgent need to harmonise HIV and STI behavioural surveillance among MSM across European countries through the adoption of common indicators, as well as the development of trend analysis in order to monitor the HIV-STI epidemic over time. The Sialon II project protocols have been elaborated for the purpose of implementing a large-scale bio-behavioural survey among MSM in Europe in line with a Second Generation Surveillance System (SGSS) approach. METHODS/DESIGN: Sialon II is a multi-centre biological and behavioural cross-sectional survey carried out across 13 European countries (Belgium, Bulgaria, Germany, Italy, Lithuania, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the UK) in community settings. A total of 4,966 MSM were enrolled in the study (3,661 participants in the TLS survey, 1,305 participants in the RDS survey). Three distinct components are foreseen in the study protocols: first, a preliminary formative research in each participating country. Second, collection of primary data using two sampling methods designed specifically for 'hard-to-reach' populations, namely Time Location Sampling (TLS) and Respondent Driven Sampling (RDS). Third, implementation of a targeted HIV/STI prevention campaign in the broader context of the data collection. DISCUSSION: Through the implementation of combined and targeted prevention complemented by meaningful surveillance among MSM, Sialon II represents a unique opportunity to pilot a bio-behavioural survey in community settings in line with the SGSS approach in a large number of EU countries. Data generated through this survey will not only provide a valuable snapshot of the HIV epidemic in MSM but will also offer an important trend analysis of the epidemiology of HIV and other STIs over time across Europe. Therefore, the Sialon II protocol and findings are likely to contribute significantly to increasing the comparability of data in EU countries through the use of common indicators and in contributing to the development of effective public health strategies and policies in areas of high need.

How many people are living with undiagnosed HIV infection? An estimate for Italy, based on surveillance data.

OBJECTIVE: To estimate the size and characteristics of the undiagnosed HIV population in Italy in 2012 applying a method that does not require surveillance data from the beginning of the HIV epidemic. METHODS: We adapted the method known as 'London method 2'; the undiagnosed population is estimated as the ratio between the estimated annual number of simultaneous HIV/clinical AIDS diagnoses and the expected annual progression rate to clinical AIDS in the undiagnosed HIV population; the latter is estimated using the CD4⁺ cell count distribution of asymptomatic patients reported to surveillance. Under-reporting/ascertainment of new diagnoses was also considered. Also, the total number of people living with HIV was estimated. RESULTS: The undiagnosed HIV population in 2012 was 13,729 (95% confidence interval: 12,152-15,592), 15,102 (13,366-17,151) and 16,475 (14,581-18,710), assuming no under-reporting/ascertainment, 10 and 20% of under-reporting/ascertainment, respectively. The percentage of undiagnosed cases was higher among HIV people aged below 25 years (25-28%), MSM (16-19%) and people born abroad (16-19%), whereas it was small among injection drug users (3%). CONCLUSION: The estimate of people in Italy with undiagnosed HIV in 2012 was in a plausible range of 12,000-18,000 cases, corresponding to 11-13% of the overall prevalence. The method is straightforward to implement only requiring annual information from the HIV surveillance system about CD4⁺ cell count and clinical stage at HIV diagnosis. Thus, it could be used to monitor if a certain prevention initiative lead to the reduction of the undiagnosed HIV population over time. It can also be easily implemented in other countries collecting the same basic information from the HIV surveillance system.

Risk factors for early mortality after AIDS in the cART era: A population-based cohort study in Italy.

BACKGROUND: Despite the dramatically improved survival due to combination antiretroviral therapies (cART), life expectancy of people with HIV/AIDS remains lower than that of the general population. This study aimed to estimate, at a population level, the survival experience of Italian people with AIDS (PWA) and to quantify the prognostic role of selected factors at diagnosis in the risk of early mortality (i.e., within six months from AIDS diagnosis). METHODS: A population-based, retrospective-cohort study was conducted among Italian PWA diagnosed between 1999 and 2009 and recorded in the national AIDS registry. The vital status, up to December 2010, of 14,552 PWA was ascertained through a record linkage procedure with the Italian mortality database. Survival probabilities were estimated through Kaplan-Meier method. To identify risk factors for early mortality from any cause, odds ratios (ORs) and corresponding 95% confidence intervals (CIs), adjusted for major confounders, were computed using multivariate logistic regression models. RESULTS: Of the 5,706 deaths registered among the 14,552 PWA included in the study, 2,757 (18.9%) occurred within six months from AIDS diagnosis. The probability of surviving six months increased from 81.2% in PWA diagnosed in 1999-2000 to 82.9% in 2009, while the 5-year survival augmented from 60.7% in PWA diagnosed in 1999-2000 to 65.4% for PWA diagnosed in 2005-2006. Elevated risks of early mortality were associated to older age (OR = 5.28; 95% CI: 4.41-6.32 for age ≥60 vs. <35 years), injecting drug use (OR = 1.71; 95% CI: 1.53-1.91 vs. heterosexual intercourse), and CD4 count <50 cells/mm(3) at AIDS diagnosis (OR = 1.87, 95% CI: 1.55-2.27 vs. ≥350). Elevated ORs for early mortality also emerged for PWA diagnosed with primary brain lymphoma (OR = 11.66, 95% CI: 7.32-18.57), or progressive multifocal leukoencephalopathy (OR = 4.21, 95% CI: 3.37-5.27). CONCLUSIONS: Our study documented, among Italian PWA, the high - though slightly decreasing - frequency of early mortality in the full cART era. These findings indicate the need for enduring and ameliorating preventive actions aimed at timely HIV testing among all individuals at risk for HIV infection and/or those who present diseases known to be related with HIV infection.

Estimating minimum adult HIV prevalence: a cross-sectional study to assess the characteristics of people living with HIV in Italy.

In 2012, we conducted a retrospective cross-sectional study to assess the number of people living with HIV linked to care and, among these, the number of people on antiretroviral therapy. The health authority in each of the 20 Italian Regions provided the list of Public Infectious Diseases Clinics providing antiretroviral therapy and monitoring people with HIV infection. We asked every Public Infectious Diseases Clinic to report the number of HIV-positive people diagnosed and linked to care and the number of those on antiretroviral therapy during 2012. In 2012, 94,146 people diagnosed with HIV and linked to care were reported. The majority were males (70.1%), Italians (84.4%), and aged between 25 and 49 years (63.4%); the probable route of transmission was heterosexual contact in 37.5% of cases, injecting drug use in 28.1%, and male-to-male contact in 27.9%. Among people in care, 20.1% had less than 350 CD4 cells/µl, 87.6% received antiretroviral therapy, and among these, 62.4% had a CD4 cell count higher than 350 cells/µl. The overall estimated prevalence of individuals diagnosed and linked to care in 2012 in Italy was 0.16 per 100 residents (all ages). Adding the estimated proportion of undiagnosed people, the estimated HIV prevalence would range between 0.19 and 0.26 per 100 residents. In Italy, the majority of people diagnosed and linked to care receive antiretroviral therapy. A higher prevalence of individuals diagnosed and linked to care was observed in Northern Italy and among males. More information for developing the HIV care continuum is necessary to improve the entire engagement in care, focusing on test-and-treat strategies to substantially reduce the proportion of people still undiagnosed or with a detectable viral load.

The continued ageing of people with AIDS in Italy: recent trend from the national AIDS Registry.

Introduction. In industrialized countries, the availability of highly active antiretroviral therapy (HAART) caused a slow but substantial ageing of the AIDS epidemic mainly due to the longer survival of persons with HIV/AIDS which has turned HIV into a manageable, chronic disease. The number of older people with AIDS is growing in many European countries. We described the impact of AIDS among persons aged 50 years or more in Italy and compared the characteristics of these cases with those of persons diagnosed with AIDS at an age younger than 50. Methods. The source of data was the Italian AIDS Registry, from 1982 to 2011. We defined "older" persons those aged 50 years or more, and younger individuals those aged less than 50 years. We built two multivariate logistic regression models: the first one to identify factors associated with being older, and the second one to identify AIDS-defining diseases correlated with being older. Variables with a P value of <0.05 were entered in the model. Results. Of the total AIDS cases, 10.5% were among persons older than 49 years. This proportion progressively increased from 0.0% in 1983 to 26.4% in 2011. Among older cases, the incidence of AIDS was 2.0 per 100 000 residents in 1996, then decreased to 1.4 per 100 000 in 2000 and levelled off around 1 per 100 000 residents until 2011. Compared to younger cases, older cases were more frequently males, Italians, diagnosed with AIDS in recent years, residing in Northern or Central Italy, non-injecting drug users, and late testers. Discussion. These findings stress the need for physicians to consider carefully the possibility of HIV infection among older individuals not to miss the opportunity to deliver prevention messages, offer HIV testing, and make an early diagnosis.