Outcomes of younger patients with mantle-cell lymphoma experiencing late relapse (>24 months): the LATE-POD study.

Patients with mantle cell lymphoma (MCL) who experience first relapse/refractoriness can be categorized into early or late progression-of-disease (POD) groups, with a threshold of 24 months from the initial MCL diagnosis. Bruton tyrosine kinase inhibitors (BTKi) are established standard treatment at first relapse, but their effectiveness as compared to chemoimmunotherapy (CIT) in late-POD patients remains unknown. In this international, observational cohort study, we evaluated outcomes amongst patients at first, late-POD beyond 24 months. Patients treated upfront with BTKi were excluded. The primary objective was progression-free survival from time of second-line therapy (PFS-2) of BTKi versus CIT. After accrual, all patients were prospectively followed-up. Overall, 385 late-POD patients were included from 10 countries. Their median age was 59 (range:19-70) years and 77% were males. Median follow-up from time of first relapse was 53 months (range:12-144). Overall, 114 patients had second-line BTKi, while 271 had CIT, consisting of rituximab-bendamustine (R-B, n=101), R-B and cytarabine (R-BAC, n=70), or other regimens (mostly cyclophosphamide-hydroxydaunorubicin-vincristine-prednisone-CHOP- or platinum-based, n=100). The two groups were balanced for clinicopathological features, and median time to first relapse (48 months for both). Overall, BTKi was associated with significantly prolonged median PFS-2 than CIT [not reached-NR vs 26 months, respectively, P=.0003], and overall survival [NR and 56 months, respectively, P=.03]. Multivariate analyses showed that BTKi was associated with lower risk of death than R-B and other regimens (hazard ratio-HR, 0.41 for R-B, 0.46 for others), but similar to R-BAC. These results may establish BTKi as the preferable second-line approach in BTKi-naïve MCL patients.

Clinic-based evaluation of point-of-care dual HIV/syphilis rapid diagnostic tests at primary healthcare antenatal facilities in South Africa and Zambia.

BACKGROUND: Southern African countries have the largest global burden of HIV and syphilis, with a high prevalence among women of reproductive age. Although antenatal screening is standard of care, syphilis screening has generally lagged behind HIV screening. We aimed to evaluate the performance and operational characteristics of two commercial dual HIV/syphilis point-of-care tests (POCTs) for simultaneous maternal HIV/syphilis screening. METHODS: A clinic-based evaluation of dual HIV/syphilis POCTs (SD Bioline and Chembio) was conducted at five primary healthcare centres (PHCs) in South Africa and Zambia. POCT results using capillary fingerprick blood were compared to reference laboratory syphilis and HIV serological assays. RESULTS: Three thousand four hundred twelve consenting pregnant women aged ≥ 18 years were enrolled. The prevalence of treponemal antibody seropositivity and HIV infection ranged from 3.7 to 9.9% (n = 253) and 17.8 to 21.3% (n = 643), respectively. Pooled sensitivity for syphilis compared to the reference assay was 66.0% (95%CI 57.7-73.4) with SD Bioline and 67.9% (95%CI 58.2-76.3) with Chembio. Pooled specificity for syphilis was above 98% with both POCTs. The sensitivities of SD Bioline and Chembio assays were 78.0% (95%CI 68.6-85.7) and 81.0% (95%CI 71.9-88.2), respectively compared to an active syphilis case definition of treponemal test positive with a rapid plasma reagin titre of ≥ 8. The negative predictive values (NPVs) based on various prevalence estimates for syphilis with both assays ranged from 97 to 99%. The pooled sensitivity for HIV was 92.1% (95%CI 89.4-94.2) with SD Bioline; and 91.5% (95%CI 88.2-93.9) with Chembio. The pooled specificities for HIV were 97.2% (95%CI 94.8-98.5) with SD Bioline and 96.7% (95%CI 95.1-97.8) with Chembio. The NPV based on various prevalence estimates for HIV with both assays was approximately 98%. Most participating women (91%) preferred dual POCTs over two single POCTs for HIV and syphilis, and healthcare providers gave favourable feedback on the utility of both assays at PHC level. CONCLUSIONS: Based on the need to improve antenatal screening coverage for syphilis, dual HIV/syphilis POCTs could be effectively incorporated into antenatal testing algorithms to enhance efforts towards elimination of mother-to-child transmission of these infections.

A clinical utility evaluation of dual HIV/Syphilis point-of-care tests in non-clinical settings for screening for HIV and syphilis in men who have sex with men.

BACKGROUND: Dual point-of-care tests (POCTs) for the simultaneous detection of antibodies to HIV and syphilis have been developed. Since community-based organisations (CBO) are effective providers of HIV and syphilis testing among men who have sex with men (MSM), evaluation of the utility of these dual tests at CBO testing services is a high priority. The aim of this study is to determine the feasibility of performing dual HIV-syphilis POCT testing among both users and providers at these non-clinical sites. METHODS: This evaluation assessed the utility of two lateral flow immunochromatographic antibody technologies for dual screening for HIV/syphilis among MSM seeking testing in four CBO testing services in Spain, Slovenia, Latvia, and Ukraine. The study's conceptual framework divides the concept of feasibility into two inter-related domains, acceptability, and usability and further breaks it down into six subdomains: learnability, willingness, suitability, satisfaction, efficacy, and effectiveness. The feasibility analysis was performed by calculating the median score in 3 stages (for individual questions, subdomains, and domains), using a summated scores method. RESULTS: The final sample included 844 participants, 60 of which were found to be HIV test positive (7.1%) and 61 (7.2%) positive on testing for syphilis. There was a small difference (1.1%) when comparing the results of the two dual POCTs under evaluation to the tests routinely used at each site. The inter-rater agreement showed a high concordance between two independent readings. The analysis of the feasibility for the users of the services indicated good satisfaction, suitability, and willingness. In addition, among 18 providers the total mean score showed good acceptability and usability, good willingness, easy learnability, high suitability, and good efficacy, but lower satisfaction and effectiveness. The operational characteristics of both dual study POCTs were well evaluated by providers. CONCLUSIONS: The introduction of dual HIV and syphilis  POCTs in CBO testing services for screening of MSM is feasible, with a high acceptability and usability both for users and providers. Implementation of dual POCTs for HIV and syphilis in CBO testing services is an opportunity for scaling up integrated HIV/syphilis testing for MSM.

Clinic-based evaluation of the dual Xpert CT/NG assay on the GeneXpert System for screening for extragenital chlamydial and gonococcal infections amongst men who have sex with men.

BACKGROUND: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections have increased globally. Asymptomatic infections represent a significant risk of long-term complications. Men who have sex with men (MSM) are disproportionally affected, underscoring the need to offer screening programmes to this population. CT/NG Point of Care Testing (POCT) constitutes a strategic tool to improve the continuum of STI care, however extensive real-life evaluations amongst at risk populations are lacking. The aim of this study is to estimate the GeneXpert CT/NG assay performance and usability for CT and NG at genital and extragenital sites for screening amongst MSM. METHODS: This study was a multi-site sexual health clinic-based evaluation (Italy, Malta and Peru) with consecutive enrolment. A first void urine sample (divided in two aliquots), two oropharyngeal and two anorectal swabs were collected for each study participant. One specimen set (one for each anatomical site) was tested with the dual index test (Cepheid) at the clinics by the healthcare staff, the other set with FDA/CE approved Nucleic Acid Amplification Tests (NAATs) at the laboratory. Clinical sites and reference laboratories participated in an internal and external quality control programme. Sensitivity, specificity, positive and negative likelihood ratios, positive and negative predictive values for each anatomical site were estimated using a meta-analytic approach. RESULTS: One thousand seven hundred two MSM were recruited across all clinical sites for a total of 5049 biological specimens. NG and CT were respectively detected in 274 and 287 of samples. Overall, the NG POCT sensitivity and specificity was 91.43% and 99.75% in urine (LR + 372.80, LR- 0.09), 89.68% and 99.55% in rectal specimens (LR + 197.30, LR- 0.10) and 75.87% and 98.77% at the pharynx respectively (LR + 61.94, LR- 0.24). The CT component of the POCT sensitivity was 84.82% and specificity 99.63% in urine (LR + 228.68, LR- 0.15), 78.07% and 99.19% respectively on rectal site (LR + 96.23, LR-0.22), 67.79% and 99.88% respectively at pharyngeal site (LR + 554.89, LR- 0.32). 95.95% of MSM reported to be willing to wait for POCT results and no provider reported difficulties in terms of performance or interpretation of the results of the Xpert CT/NG. CONCLUSION: Rapid turnaround time, ease of use and high acceptability make the Xpert CT/NG testing system a strategic tool for increasing testing frequency, reaching those not yet tested and offering the possibility of immediate treatment if needed. The assay showed good negative likelihood ratios and confirms its use to rule out CT/NG infections. Sensitivity varied across sites and pathogens. Periodic staff training at the testing sites should be mandatory.

A multi-country comparative study of two treponemal tests for the serodiagnosis of syphilis amongst men who have sex with men (MSM): Chemo-luminescent assay vs Treponema pallidum particle agglutination assay.

INTRODUCTION: International guidelines recommend routine screening for syphilis (aetiological agent: Treponema pallidum subspecies pallidum) amongst key populations and vulnerable populations using tests detecting treponemal and non-treponemal antibodies. Whilst treponemal tests have high sensitivities and specificities, they differ regarding subjective or objective interpretation, throughput and workload. Chemiluminescence immunoassays (CLIAs) are cost- and time-effective automated methods for detecting treponemal antibodies. The Treponema pallidum particle agglutination assay (TPPA) has been considered the "gold standard" treponemal assay, however, this includes a highly manual procedure, low throughput and subjective interpretation. The present multi-country study evaluated the ADVIA Centaur® Syphilis CLIA (Siemens Healthcare) assay compared to the reference SERODIA-TP·PA® (Fujirebio Diagnostics) for the serodiagnosis of syphilis amongst men who have sex with men (MSM). METHOD: 1,485 MSM were enrolled in Brighton (UK), Malta, and Verona (Italy) as part of a larger WHO multi-country and multi-site ProSPeRo study. Ethical approval was obtained. Serum was tested with the ADVIA Centaur® Syphilis CLIA assay and SERODIA-TP·PA®, in accordance with the manufacturers' instructions, for a first round of validation. A second round of validation was carried out for discrepant results that were additionally tested with both Western Blot (Westernblot EUROIMMUN®) and an Immunoblot (INNO-LIA, Fujirebio Diagnostics). Sensitivity, specificity, positive and negative predictive value (PPV and NPV), likelihood ratios (positive/negative), and the Diagnostic Odds Ratio (DOR)/pre-post-test probability (Fagan's nomogram) were calculated. RESULTS: Out of 1,485 eligible samples analysed in the first phase, the SERODIA-TP·PA® identified 360 positive and 1,125 negative cases. The ADVIA Centaur® Syphilis CLIA assay (Siemens) identified 366 positives, missclassifying one TPPA-positive sample. In the second phase, the ADVIA Centaur® Syphilis CLIA resulted in 1 false negative and 4 false positive results. Considering the syphilis study prevalence of 24% (95% CI: 22-26.7), The sensitivity of the ADVIA Centaur® Syphilis CLIA assay was 99.7% (95% CI: 98.5-100), and the specificity was 99.4% (95% CI: 98.7-99.7). The ROC area values were 0.996 (95% CI: 0.992-0.999), and both the PPV and NPV values were above 98% (PPV 98.1%, 95% CI: 96.1-99.2; NPV 99.9%, 95% CI: 99.5-100). CONCLUSIONS: The ADVIA Centaur® Syphilis CLIA assay showed similar performance compared to the SERODIA-TP·PA®. Considering the study is based on QUADAS principles and with a homogeneous population, results are also likely to be generalisable to MSM population but potentially not applicable to lower prevalence populations routinely screened for syphilis. The automated CLIA treponemal assay confirmed to be accurate and appropriate for routine initial syphilis screening, i.e. when the reverse testing algorithm is applied.

Independent clinic-based evaluation of dual POCTs for screening for HIV and syphilis in men who have sex with men in Italy, Malta, Peru, and the United Kingdom.

INTRODUCTION: Globally, the incidence of HIV and syphilis can be reduced by the use of validated point of care tests (POCTs). As part of the WHO PRoSPeRo Network, we aimed to evaluate the performance, acceptability, and operational characteristics of two dual HIV/syphilis POCTs (Bioline HIV/Syphilis Duo (Abbott) and DPP® HIV-Syphilis assay (Chembio) for the screening of HIV and syphilis amongst men who have sex with men (MSM). METHOD AND ANALYSES: A cross sectional study of 2,577 MSM in Italy, Malta, Peru, and the United Kingdom (UK) presenting to seven clinic sites, were enrolled. Finger prick blood was collected to perform POCTs and results compared with standard laboratory investigations on venepuncture blood. Acceptability and operational characteristics were assessed using questionnaires. Diagnostic meta-analysis was used to combine data from the evaluation sites. RESULTS: Based on laboratory tests, 23.46% (n = 598/2549) of participants were confirmed HIV positive, and 35.88% of participants (n = 901/2511) were positive on treponemal reference testing. Of all participants showing evidence of antibodies to Treponema pallidum, 50.56% (n = 455/900) were Rapid Plasma Reagin (RPR) test reactive. Of HIV positive individuals, 60.62% (n = 354/584) had evidence of antibodies to T. pallidum, and of these 60.45% (n = 214/354) exhibited reactive RPR tests indicating probable (co)infection. For Bioline POCT, pooled sensitivities and specificities for HIV were 98.95% and 99.89% respectively, and for syphilis were 73.79% and 99.57%. For Chembio pooled sensitivities and specificities for HIV were 98.66% and 99.55%, and for syphilis were 78.60% and 99.48%. Both tests can detect greater than 90% of probable active syphilis cases, as defined by reactive RPR and treponemal test results. These dual POCTs were preferred by 74.77% (n = 1,926) of participants, due to their convenience, and the operational characteristics made them acceptable to health care providers (HCPs). CONCLUSIONS: Both the Bioline and the Chembio dual POCT for syphilis and HIV had acceptable performance, acceptability and operational characteristics amongst MSM in the PRoSPeRo network. These dual POCTs could serve as a strategic, more cost effective, patient and healthcare provider (HCP) friendly alternative to conventional testing; in clinical and other field settings, especially those in resource-limited settings.

Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South Africa.

BACKGROUND: In 2018, the World Health Organization commenced a multi-country validation study of the Cepheid GeneXpert for a range of molecular-based point-of-care (POC) tests in primary care settings. One study arm focused on the evaluation of POC tests for screening 'women at risk' for chlamydia (CT), gonorrhoea (NG) and trichomonas (TV) in four countries - Australia, Guatemala, Morocco and South Africa. METHODS: Study participants completed a pre-test questionnaire which included demographics, clinical information and general questions on POC testing (POCT). Two vaginal swab samples (either self-collected or clinician collected) from each patient were tested on the GeneXpert at the POC and at a reference laboratory using quality-assured nucleic acid amplification tests (NAATs). RESULTS: One thousand three hundred and eighty-three women were enrolled: 58.6% from South Africa, 29.2% from Morocco, 6.2% from Guatemala, and 6.0% from Australia. 1296 samples for CT/NG and 1380 samples for TV were tested by the GeneXpert and the reference NAAT. The rate of unsuccessful tests on the GeneXpert was 1.9% for CT, 1.5% for NG and 0.96% for TV. The prevalence of CT, NG and TV was 31%, 13% and 23%, respectively. 1.5% of samples were positive for all three infections; 7.8% were positive for CT and NG; 2.4% were positive for NG and TV; and 7.3% were positive for CT and TV. Compared to reference NAATs, pooled estimates of sensitivity for the GeneXpert tests were 83.7% (95% confidence intervals 69.2-92.1) for CT, 90.5% (85.1-94.1) for NG and 64.7% (58.1-70.7) for TV (although estimates varied considerably between countries). Estimates for specificity were ≥96% for all three tests both within- and between-countries. Pooled positive and negative likelihood ratios were: 32.7 ([CI] 21.2-50.5) and 0.17 (0.08-0.33) for CT; 95.3 (36.9-245.7) and 0.10 (0.06-0.15) for NG; and 56.5 (31.6-101.1) and 0.35 (0.27-0.47) for TV. CONCLUSION: This multi-country evaluation is the first of its kind world-wide. Positive likelihood ratios, as well as specificity estimates, indicate the GeneXpert POC test results for CT, NG and TV were clinically acceptable for ruling in the presence of disease. However, negative likelihood ratios and variable sensitivity estimates from this study were poorer than expected for ruling out these infections, particularly for TV. TRIAL REGISTRATION: Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee, as well as local ethics committees from all participating countries.

Clinical efficacy of different monoclonal antibody regimens among non-hospitalised patients with mild to moderate COVID-19 at high risk for disease progression: a prospective cohort study.

This study aimed to compare the clinical progression of COVID-19 in high-risk outpatients treated with the monoclonal antibodies (mAb) bamlanivimab, bamlanivimab-etesevimab and casirivimab-imdevimab. This is an observational, multi-centre, prospective study conducted from 18 March to 15 July 2021 in eight Italian tertiary-care hospitals including mild-to-moderate COVID-19 outpatients receiving bamlanivimab (700 mg), bamlanivimab-etesevimab (700-1400 mg) or casirivimab-imdevimab (1200-1200 mg). All patients were at high risk of COVID-19 progression according to Italian Medicines Agency definitions. In a patient subgroup, SARS-CoV-2 variant and anti-SARS-CoV-2 serology were analysed at baseline. Factors associated with 28-day all-cause hospitalisation were identified using multivariable multilevel logistic regression (MMLR) and summarised with adjusted odds ratio (aOR) and 95% confidence interval (CI). A total of 635 outpatients received mAb: 161 (25.4%) bamlanivimab, 396 (62.4%) bamlanivimab-etesevimab and 78 (12.2%) casirivimab-imdevimab. Ninety-five (15%) patients received full or partial SARS-CoV-2 vaccination. The B.1.1.7 (Alpha) variant was detected in 99% of patients. Baseline serology showed no significant differences among the three mAb regimen groups. Twenty-eight-day all-cause hospitalisation was 11.3%, with a significantly higher proportion (p 0.001) in the bamlanivimab group (18.6%), compared to the bamlanivimab-etesevimab (10.1%) and casirivimab-imdevimab (2.6%) groups. On MMLR, aORs for 28-day all-cause hospitalisation were significantly lower in patients receiving bamlanivimab-etesevimab (aOR 0.51, 95% CI 0.30-0.88 p 0.015) and casirivimab-imdevimab (aOR 0.14, 95% CI 0.03-0.61, p 0.009) compared to those receiving bamlanivimab. No patients with a history of vaccination were hospitalised. The study suggests differences in clinical outcomes among the first available mAb regimens for treating high-risk COVID-19 outpatients. Randomised trials are needed to compare efficacy of mAb combination regimens in high-risk populations and according to circulating variants.

What is the empirical basis for converting banded ordinal data on numbers of sex partners among MSM into a continuous scale level variable? A secondary analysis of 13 surveys across 17 countries.

BACKGROUND: To provide empirically based guidance for substituting partner number categories in large MSM surveys with mean numbers of sexual and condomless anal intercourse (CAI) partners in a secondary analysis of survey data. METHODS: We collated data on numbers of sexual and CAI partners reported in a continuous scale (write-in number) in thirteen MSM surveys on sexual health and behaviour across 17 countries. Pooled descriptive statistics for the number of sexual and CAI partners during the last twelve (N = 55,180) and 6 months (N = 31,759) were calculated for two sets of categories commonly used in reporting numbers of sexual partners in sexual behaviour surveys. RESULTS: The pooled mean number of partners in the previous 12 months for the total sample was 15.8 partners (SD = 36.6), while the median number of partners was 5 (IQR = 2-15). Means for number of partners in the previous 12 months for the first set of categories were: 16.4 for 11-20 partners (SD = 3.3); 27.8 for 21-30 (SD = 2.8); 38.6 for 31-40 (SD = 2.4); 49.6 for 41-50 (SD = 1.5); and 128.2 for 'more than 50' (SD = 98.1). Alternative upper cut-offs: 43.4 for 'more than 10' (SD = 57.7); 65.3 for 'more than 20' (SD = 70.3). Self-reported partner numbers for both time frames consistently exceeded 200 or 300. While there was substantial variation of overall means across surveys, the means for all chosen categories were very similar. Partner numbers above nine mainly clustered at multiples of tens, regardless of the selected time frame. The overall means for CAI partners were lower than those for sexual partners; however, such difference was completely absent from all categories beyond ten sexual and CAI partners. CONCLUSIONS: Clustering of reported partner numbers confirm common MSM sexual behaviour surveys' questionnaire piloting feedback indicating that responses to numbers of sexual partners beyond 10 are best guesses rather than precise counts, but large partner numbers above typical upper cut-offs are common.

COVID-19 seroprevalence amongst healthcare workers: potential biases in estimating infection prevalence.

SARS-CoV-2 serological tests are used to assess the infection seroprevalence within a population. This study aims at assessing potential biases in estimating infection prevalence amongst healthcare workers (HCWs) when different diagnostic criteria are considered. A multi-site cross-sectional study was carried out in April-September 2020 amongst 1.367 Italian HCWs. SARS-CoV-2 prevalence was assessed using three diagnostic criteria: RT-PCR on nasopharyngeal swab, point-of-care fingerprick serological test (POCT) result and COVID-19 clinical pathognomonic presentation. A logistic regression model was used to estimate the probability of POCT-positive result in relation to the time since infection (RT-PCR positivity). Among 1.367 HCWs, 69.2% were working in COVID-19 units. Statistically significant differences in age, role and gender were observed between COVID-19/non-COVID-19 units. Prevalence of SARS-CoV-2 infection varied according to the criterion considered: 6.7% for POCT, 8.1% for RT-PCR, 10.0% for either POCT or RT-PCR, 9.6% for infection pathognomonic clinical presentation and 17.6% when at least one of the previous criteria was present. The probability of POCT-positive result decreased by 1.1% every 10 days from the infection. This study highlights potential biases in estimating SARS-CoV-2 point-prevalence data according to the criteria used. Although informative on infection susceptibility and herd immunity level, POCT serological tests are not the best predictors of previous COVID-19 infections for public health monitoring programmes.

Mental health for LGBTQI people: a policies' review.

The mental health of lesbian, gay, bisexual, transgender, queer, intersexual (LGBTQI) individuals is significantly influenced by many factors such as difficulties in coming-out, poor acceptance, isolation and discrimination as well as minority-related stress. LGBTQI individuals, in fact, show a significant higher risk of mental health conditions, substance- use disorders and suicide. In addition, mental health services access may be difficult for personal and social barriers as well as a lack of adequate and specific mental health support. This review aims to assess and describe international policies, guidelines, position statements and recommendations regarding the promotion and protection of mental health rights for LGBTQI people. The search has been focussed on peer-reviewed papers, Governmental and Mental Health Association- Guidelines and Position Statements, Health Agencies - Guidelines and Position Statements (with a specific focus on mental health), LGBTQI Alliances and Foundations Publishing (with a specific focus on mental health). In addition, relevant international initiatives, and projects in the field of LGBTQI mental health will be described.

Barriers in care pathways and unmet mental health needs in LGBTIQ + communities.

Lesbian, gay, bisexual, transgender, intersex, queer people and minority gender identities and sexualities (LGBTIQ+) are often stigmatized and experience discrimination in health care settings, leading to poorer mental health outcomes and unmet needs compared to heterosexual and cisgendered peers. It is thus imperative that mental health providers consider and address structural challenges in order to reduce mental health inequalities of this population. This narrative review assessed the barriers that may prevent access to care and the pathways for care in LGBTIQ + communities. PubMed, PsycInfo, Embase, and Scopus were searched for papers published between December 2021 and February 2022. A total of 107 papers were included with studies reflecting five themes: (1) Unmet mental health needs; (2) Young people; (3) Substance abuse and addiction; (4) Barriers and pathways to care; and (5) Interventions. Findings demonstrate that LGBTIQ + people experience stigmatization and higher rates of substance misuse and mental ill health, which may lead to barriers in accessing health care services, and fewer tailored interventions being provided. These findings have implications for policy, health care screening, and how specialist services are structured. Substantial gaps in the evidence-base exist, and future research should examine how mental health care providers can challenge social issues that maintain discriminatory and stigmatizing practices, and support LGBTIQ + individuals to sustain their resilience.

Self-harm and suicidality among LGBTIQ people: a systematic review and meta-analysis.

Research evidence has consistently documented a higher risk of suicidality in the Lesbian, Gay, Bisexual, Transgender, Intersex, and Queer (LGBTIQ) population. This systematic review and meta-analysis aimed to report a detailed description of research data regarding the risk of Attempted Suicide (SA), Suicide Ideation (SI), and Non-Suicidal Self-Injury (NSSI) behaviours for LGBTIQ people and their subgroups. Medline, Scopus, PsycINFO, and EMBASE were searched for studies reporting a comparative estimation of SA, SI, and NSSI rates among LGBTIQ population and the general population (i.e. heterosexual/cisgender), without restrictions on participants' age and setting for the enrolment. Pooled analyses were based on odds ratios (ORs, with 95% CIs), estimated through inverse variance models with random effects. Fifty studies were selected for the quantitative synthesis and included fifty samples involving 3.735.601 controls and 87.252 LGBTIQ people. LGBTIQ people reported an increased risk of SA (OR:4.36[95%CI:3.32;5.71]), SI (OR:3.76[95%CI:3.02;4.69]), and NSSI (OR:4.24[95%CI:3.23;5.55]). Among LGBTIQ subgroups, the Bisexual group has shown the highest risk of suicidality (SA, OR:6.71; SI, OR:5.04; NSSI, OR: 5.03), followed by the Lesbian-Gay for attempted suicide (SA, OR:6.03), and the Transgender-Intersex-Queer for suicide ideation and non-suicidal self-injury (SI and NSSI, OR:3.42). The quality of the evidence ranged from low to moderate. Our findings have shown that LGBTIQ people report a higher risk of suicidality compared with their cisgender/heterosexual peers. This evidence may contribute to the public awareness on LGBTQI mental health needs and suggest supportive strategies as well as preventive interventions (e.g. supportive programs, counselling, and destigmatizing efforts) as parts of a tailored health-care planning aimed to reduce psychiatric morbidity and mortality in this at-risk population.

Mental health in transgender individuals: a systematic review.

Several lines of evidence indicate the prevalence of mental health disorders in Transgender (TG) individuals is higher than that of cisgender individuals or the general population. In this systematic review, we aim to propose a summary of some of the most significant research investigating mental health disorders' prevalence among this population. We performed a double-blind systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting (PRISMA) on PUBMED/MEDLINE and SCOPUS, specifically using peer-reviewed articles examining the mental health status of transgender (TG) individuals. This review did not exclude any research based on publication date. The last search was performed in February 2022. The employed search strategy led to the selection of 165 peer-reviewed articles. The majority of these papers presented a cross-sectional design with self-reported diagnoses and symptoms, signaling a significant prevalence of mental health disorders amongst TG Individuals. Of the reviewed articles, 72 examined the prevalence of mood and anxiety disorders; 8 examined eating disorders; 43 examined the prevalence of suicidal or self-harm ideation or behaviors; 5 papers examined the prevalence of trauma and stress-related disorders; 10 examined the frequency of personality disorders; 44 examined substance use disorders; and 9 papers examined the prevalence of autism spectrum disorder. Finally, 22 studies reported on the prevalence of TG individuals diagnosed with co-morbid mental health disorders or unspecified mental disorders. Our findings coincide with existing research, which indicates TG individuals do experience a higher prevalence of mental health disorders than that of the general population or cisgender individuals. However, further research is needed to address the existing gaps in knowledge.

Mediterranean diet and physical activity in Down syndrome pediatric subjects: the DONUT STUDY.

INTRODUCTION: Children with Down syndrome (DS) are characterised by peculiar dietary choices and approach to physical activity. The aim of this study is to quantify their adherence to the Mediterranean diet, their level of physical activity and lipid profile. METHODS: Cross-sectional study, involving 61 children affected by DS. Parents of the patients were requested to complete two questionnaires, Mediterranean Diet Quality Index in children and adolescents (KIDMED) and Godin Leisure-Time Physical Activity Questionnaire (Godin). In addition, children underwent a venous sampling to check their lipid profile. RESULTS: High scores on KIDMED and Godin were found and were associated with a reduced likelihood of being overweight or obese (0.001< p < 0.077; 0.001< p < 0.248). The level of physical activity and the probability of finding pathological HDL values in plasma were inversely related (0.001< p < 0.263). CONCLUSIONS: The DONUT study proves that KIDMED and Godin questionnaires can identify children affected by DS that can lead to develop inadequate anthropometric variables and low levels of HDL cholesterol. Moreover, the results of this study show that, despite potential difficulties in the pursuit of a correct diet and an adequate approach to physical activity, children with DS could achieve results that are substantially like those of non-DS children.

Estimating the percentage of European MSM eligible for PrEP: insights from a bio-behavioural survey in thirteen cities.

OBJECTIVES: This paper aims to estimate the percentage of European men who have sex with men (MSM) who may benefit from pre-exposure prophylaxis (PrEP), applying the three most widely used HIV risk indices for MSM (MSM Risk Index, Menza score, San Diego Early Test (SDET) score) and drawing on a large-scale multisite bio-behavioural survey (Sialon II). METHODS: The Sialon II study was a bio-behavioural survey among MSM implemented in 13 European cities using either time-location sampling or respondent-driven sampling. Biological and behavioural data from 4901 MSM were collected. Only behavioural data of HIV-negative individuals were considered. Three widely used risk indices to assess HIV acquisition risk among MSM were used to estimate individual HIV risk scores and PrEP eligibility criteria. RESULTS: 4219 HIV-negative MSM were considered. Regardless the HIV risk score used and the city, percentages of MSM eligible for PrEP were found to range between 5.19% and 73.84%. Overall, the MSM Risk Index and the Menza score yielded broadly similar percentages, whereas the SDET Index provided estimates constantly lower across all cities. Although all the three scores correlated positively (r>0.6), their concordance was highly variable (0.01

Populations size estimations using SS-PSE among MSM in four European cities: how many MSM are living with HIV?

BACKGROUND: Although men who have sex with men (MSM) are considered at high risk for transmission of sexually transmitted infections, including HIV, there are few studies estimating the population size of MSM in Europe. We used network data from a survey of MSM in four cities to perform successive sampling-population size estimations (SS-PSE) to estimate MSM population sizes. METHODS: Data were collected in 2013-14 in Bratislava, Bucharest, Verona and Vilnius using respondent-driven sampling (RDS). SS-PSE uses a Bayesian framework to approximate the RDS sampling structure via a successive sampling model and uses the selection order of the sample to provide information about the distribution of network sizes over the population members of MSM. RESULTS: We estimate roughly 4600 MSM in Bratislava, 25 300 MSM in Bucharest, 7200 in Verona and 2900 in Vilnius. This represents 2.9% of the estimated adult male population in Bratislava, 2.3% in Bucharest, 2.7% in Verona and 1.5% in Vilnius. The number of MSM living with HIV would roughly be 200 in Bratislava, 4554 in Bucharest, 690 in Verona and 100 in Vilnius. CONCLUSIONS: Benefits of this method are that no additional information from an RDS survey needs to be collected, that the sizes can be calculated ex post facto a survey and that there is a software programme that can run the SS-PSE models. However, this method relies on having reliable priors. Although many countries are estimating the sizes of their vulnerable populations, European countries have yet to incorporate similar and novel methods.

Healthcare professionals' assumptions as barriers to LGBTI healthcare.

Lesbian, gay, bisexual, trans and intersex (LGBTI) people experience significant healthcare inequalities and barriers to healthcare services. Contextualised within six Member States of the European Union (EU), this paper discusses efforts to identify and explore the nature of barriers to healthcare as part of Health4LGBTI, a 2-year pilot project funded by the EU. Data were generated through focus groups and interviews with LGBTI people and healthcare professionals and analysed using thematic analysis. Findings reveal that barriers to healthcare are underpinned by two related assumptions held by healthcare professionals: first, the assumption that patients are heterosexual, cisgender and non-intersex by default; second, the assumption that LGBTI people do not experience significant problems (and therefore that their experience is mostly irrelevant to healthcare). On the other hand, it is notable that responding healthcare professionals were broadly 'LGBTI-friendly'. Thus, we argue that efforts to improve LGBTI healthcare should not be limited to engaging with healthcare professionals with negative views of LGBTI people. Rather, such efforts should also tackle these assumptions amongst LGBTI-friendly healthcare professionals.

The Role of Gay-Related Stigma in HIV-Risk Behavior Among Sexual Minority Men in Europe.

Sexual orientation stigma stems from discriminatory social contexts and may ultimately impact the behavioral health of stigmatized individuals through stress-related pathways. Sexual minority stigma is of particular concern in Europe given the diversity of social contexts on the continent and sexual minority men's rapidly increasing risk of HIV infection, especially in Central and Eastern Europe, potentially rooted in stigma. This study assesses whether stigma in the ubiquitous social contexts surrounding sexual minority men (e.g., family, workplace, government) may place them at higher risk for HIV contraction across six countries. We utilized a large cross-sectional survey sample of HIV-negative sexual minority men (N = 2087; mean age = 31.6, SD = 9.7) from six European countries to test whether those who reported sexual orientation stigma also engaged in more HIV risk-related behaviors, including condomless sex with casual partners (in the absence of PrEP) and substance use before and during sex. Regression analyses were performed in Mplus. We found that a one standard deviation increase in reported sexual orientation stigma was significantly associated with the following during the last sexual encounter: a 19% increase in odds of sex under the influence of alcohol, 27% increase in odds of sex under the influence of cannabis, 49% increase in odds of sex under the influence of illicit drugs, an 11% increase in odds of condomless sex with casual partners in the past 6 months, and a 26% increase in odds of knowing where to receive an HIV test. Sexual minority men who reported perceiving greater sexual orientation-related stigma within their ubiquitous social contexts were significantly more likely to report sexual risk and alcohol and drug use during their last sexual encounter, yet reported more knowledge of preventive services. Contextual stigma might serve as a precursor to behavioral risks of HIV infection, generating maladaptive stress responses capable of being modified through individually-focused interventions. Structural interventions are also needed to ultimately reduce stigma at its source.

Co-producing knowledge of lesbian, gay, bisexual, trans and intersex (LGBTI) health-care inequalities via rapid reviews of grey literature in 27 EU Member States.

BACKGROUND: The health inequalities experienced by lesbian, gay, bisexual, trans and intersex (LGBTI) people are well documented with several reviews of global research summarizing key inequalities. These reviews also show how the health-care needs of LGBTI people are often poorly understood whilst suggesting that targeted initiatives to reduce inequalities should involve LGBTI people. OBJECTIVES: To determine what is known about the health-care inequalities faced by LGBTI people? What are the barriers faced by LGBTI people whilst accessing health care, and health professionals when providing care? What examples of promising practice exist? DESIGN: Rapid reviews of grey literature were co-produced with LGBTI people in 27 countries followed by a thematic analysis and synthesis across all data sets. The review included grey literature from each country that might not otherwise be accessible due to language barriers. MAIN RESULTS: Rapid reviews showed that LGBTI people faced various inequalities and barriers whilst accessing health care. Where heterosexuality, binary gender and assumed male/female sex characteristics were upheld as the norm, and where LGBTI people differed from these norms, discrimination could result. In consultations where LGBTI people feared discrimination and did not disclose their LGBTI status, health professionals lacked the information required for appropriate assessments. CONCLUSION: With greater understanding of sexual orientation (LGB people), gender identity (trans people) and sex characteristics (intersex people), combined with access to contemporary knowledge and training, health professionals can work in collaboration with researchers, policymakers and LGBTI people to develop systems that are better attuned to the needs of all service users.