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Background Relationship status is an important factor associated with condomless anal intercourse (CAI) amongst men who have sex with men (MSM). Methods A multi-centre bio-behavioural survey with MSM was conducted in 13 European cities (n = 4901) exploring factors associated with CAI via bivariate and multivariate multilevel logistic regression analyses. Results Likelihood of CAI with casual partners was associated with being 'out' to a majority (AOR = 1.19;95% CI 1,1.42); knowing their HIV status (AOR = 1.86; 95% CI 1.25,2.76); using substances (1–2 AOR = 1.39; 95% CI 1.16,1.63, 2+ AOR = 1.81; 95% CI 1.35,2.42); being older (AOR = 0.98; 95% CI 0.97,0.99); successful sero-communication (AOR = 0.79; 95% CI 0.67,0.94); and, not having a recent HIV test (AOR = 0.78; 95% CI 0.66,0.92). CAI with steady partners was associated with successful sero-communication (AOR = 2.72; 95% CI 2.72,3.66); not having a recent HIV test (AOR = 1.26; 95% CI 1.09,1.46), and; being older (AOR = 0.99; 95% CI 0.98,0.99). Conclusions Understandings of partner type and/or relationship status in relation to CAI amongst MSM can potentially play an important role in the development of culturally appropriate HIV/STI prevention and risk-reduction efforts targeting at-risk MSM. Our results speak to the need to consider segmented and tailored public health and health promotion initiatives for MSM with differing CAI behaviours and relationship profiles. [ABSTRACT FROM AUTHOR]

Background Throughout the last decade substantial research has been undertaken to develop evidence-based behaviour change interventions for sexual health promotion. Primary care could provide an opportunistic entry for brief sexual health communication. Objectives We conducted a systematic review to explore opportunistic sexual and reproductive health services for sexual health communication delivered at primary health care level. Search strategy We searched for studies on PubMed, ProQuest, CINAHL, Jstor, Scopus/Science Direct, Cochrane database of systematic reviews, EBSCO, CINAHL, PsychoInfo, and Web of Knowledge. Both published and unpublished articles were reviewed. Selection criteria All randomised controlled trials and controlled clinical trials were included. Participants of all ages, from adolescence onwards were included. Brief (10-60 minutes) interventions including some aspect of communication on sexual health issues were included. Data collection and analysis Data were extracted by two reviewers independently using a standardised form. Interventions differed from each other, hence meta-analysis was not performed, and results are presented individually. Main results A total of 247 articles were selected for full-text evaluation, 31 of which were included. Sexually transmitted infections ( STIs)/ HIV were less often reported in the intervention group compared with the control group. Condom use was higher in most studies in the intervention group. Numbers of sexual partners and unprotected sexual intercourse were lower in the intervention groups. Conclusions There is evidence that brief counselling interventions have some effect in the reduction and prevention of STIs/ HIV. Some questions could not be answered, such as the effect over time and in different settings and population groups. [ABSTRACT FROM AUTHOR]

BackgroundSexual well-being is fundamental to physical and emotional health, and the ability to achieve it depends on access to comprehensive sexuality information and high-quality sexual health care from evidence-informed, nonjudgmental providers. Adequate and timely delivery of these components to individuals who are at high risk for sexually transmitted infections (STIs), including HIV, and unintended pregnancies promotes sexual health and mitigates consequences arising from risky sexual behavior. Brief interventions that allow health care providers to improve the information available to clients and motivate and help them to develop risk-reduction skills are seen as efficient ways to improve knowledge, change client behavior, and reduce provider stigma regarding sexual health. ObjectiveThe aim of the study is to evaluate five aspects of feasibility (acceptability, willingness, safety, satisfaction, and process) of a brief sexuality-related communication (BSC) intervention based on motivational interviewing and behavior change techniques in primary health care settings in low- and middle-income countries (LMICs). MethodsThis protocol outlines a multisite, multiphase study of feasibility of a BSC intervention in primary health care settings in LMICs that will be examined across four phases of the study. Phases I through III involve the collection of formative, qualitative data to examine provider and client perceptions of the feasibility of the intervention, adaptation of the intervention guide, and training providers on how to implement the final version of the BSC intervention. During phase IV, the feasibility of the intervention will be tested in a nonrandomized pre-post test trial where providers and clients will be followed for 6 months and participate in multiphase data collection. ResultsPhase I is currently underway in Moldova, and phases I and II were completed in Peru in late 2019. Results are expected for the feasibility study in 2021. ConclusionsThis feasibility study will determine whether the implementation of brief intervention programs aimed at improving sexual health outcomes is possible in the constraints of LMIC health systems and will add to our understanding of factors shaping clinical practice among primary care providers. International Registered Report Identifier (IRRID)DERR1-10.2196/15569

Introduction: In 2016, WHO estimated there were roughly 374 million new infections among adults of the following four curable sexually transmitted infections (STIs): chlamydia (caused by Chlamydia trachomatis (CT)), gonorrhoea ( Neisseria gonorrhoeae (NG)), syphilis ( Treponema pallidum ) and trichomoniasis ( Trichomonas vaginalis (TV)). Accurate point-of-care tests (POCTs) for screening of genital and extragenital CT, NG and TV infections are of great value and have been developed during recent decade. Several tests are commercially available and have shown encouraging performance compared with 'gold-standard' reference tests in laboratory-based studies. However, there is limited data on their clinical performance, including at the POC. Key populations, such as men who have sex with men (MSM), are at higher risk of these STIs at genital and extragenital sites and these STIs are often asymptomatic, especially in extragenital sites and in women. We will conduct a clinical-based evaluation to assess the performance characteristics and acceptability to end-users of molecular-based diagnostic technology for POC/near patient use of the Xpert CT/NG (Cepheid, Sunnyvale, California, USA) test for screening of genital, anorectal and pharyngeal CT and NG infections in MSM and the Xpert CT/NG and Xpert TV (Cepheid, Sunnyvale, California, USA) for screening of genital CT, NG and TV among women at risk for these STIs compared with gold-standard reference nucleic acid amplification tests. This master protocol outlines the overall research approach that will be used in seven countries., Method and Analyses: Consecutive MSM and women at risk presenting at the clinical sites in high, and low- and middle-income countries will be enrolled. The POCTs to be evaluated are Xpert CT/NG and Xpert TV. All procedures will be carried out by trained healthcare staff and tests performed in strict accordance with the manufacturer's instructions. The sensitivity, specificity, positive and negative predictive values for each POCT will be calculated. The study is ongoing with recruitment expected to be completed in all countries by mid-2022 to late-2022., Ethics and Dissemination: Prior to enrolment, this core protocol was independently peer-reviewed and approved by the research project review panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). The core protocol has been slightly adapted accordingly to individual countries and adaptations approved by both RP2 and ERC, as well as all relevant institutional review boards at each participating site. Results will be disseminated through peer-reviewed journals and presented at relevant national/international conferences., Competing Interests: Competing interests: The POCT manufacturer discloses and furnishes free of charge to WHO the information and sufficient quantities of the product(s) in order to enable this evaluation as part of the WHO/RHR STI POC initiative. WHO is entitled to evaluate and publish the trial results, and to exclusively control this evaluation and the content of the aforesaid publication. WHO shall submit any proposed publication to the POCT manufacturer for review, comments received will be considered in good faith, but the decision to publish rests with WHO., (© World Health Organization 2024. Licensee BMJ.)

The World Health Organization has been involved in male contraceptive development for over 50 years. In line with its functions and mandate, World Health Organization works with diverse stakeholders to support research, develop norms and standards, engage member states, facilitate prequalification, introduction and scale up, measurement, and tracking of contraceptives. World Health Organization has a key role in galvanizing global efforts to ensure universal access to contraception services irrespective of income group. Regarding male contraceptive development, World Health Organization has provided technical leadership, supported early research, created and supported research centers, built research capacity in various countries, and standardized semen analysis procedures. In this paper, a detailed description is provided with examples across the various stages of male contraceptive development. Limited funding to World Health Organization is a key challenge., (© 2024 World Health Organization; licensed by American Society of Andrology and European Academy of Andrology. Andrology published by Wiley Periodicals LLC on behalf of American Society of Andrology and European Academy of Andrology.)

Introduction: Although sexual health has been holistically defined to include sexual satisfaction, it has been largely absent in health services and sexual and reproductive health and rights programmes in many parts of the world. We propose sexual satisfaction as a useful indicator, as one of the proxy measures for sexual health and well-being and as a component of well-being in general., Methods: The Sialon II project is a multicentre biological and behavioural cross-sectional community-based survey implemented across 13 European cities during 2013-2014 among men who have sex with men. Sexual satisfaction was explored using one single item: 'How satisfied are you with your sex life?' A multivariable multilevel logistic random-intercept model was estimated to identify factors associated with reporting positive sexual satisfaction versus negative sexual satisfaction., Results: Age, the number of partners and self-reported HIV status were not significantly associated with sexual satisfaction in the multivariate model. Participants reporting an insertive role or reported both an insertive and receptive role during the last anal intercourse were more likely to be sexually satisfied, compared with a receptive role. Participants reporting anal intercourse with a condom were more likely to be satisfied than those declaring no anal intercourse in the last 6 months, but no significant association was found compared with anal intercourse without condom. Knowledge of HIV-serostatus concordance with the last sexual partner was positively correlated with sexual satisfaction. Having had sexual intercourse with non-steady partners only in the last 6 months was negatively correlated. The more positive participants perceived their work/school, parents and friends/acquaintances' attitudes towards gay or bisexual persons, the higher the odds they were satisfied with their sexual life., Conclusion: Using a single item on sexual satisfaction in a bio-behavioural study, our analysis has shown that it is associated with individual, interpersonal and social/structural factors and has proven its usefulness as a sexual health indicator among men who have sex with men., Competing Interests: Competing interests: None declared., (© World Health Organization 2024. Licensee BMJ.)

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., (© 2024. The Author(s).)

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., (© 2024. The Author(s).)

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., (© 2024. The Author(s).)

Background: Sexually transmitted infections (STIs) such as syphilis and HIV remain to be a significant public health issue worldwide. Dual rapid point-of-care tests (POCTs) have shown promise for detecting antibodies to HIV and syphilis but have not been fully evaluated in the field. Our study supported the WHO ProSPeRo study on Sexually Transmitted Infection Point-of-Care Testing (STI POCT) by providing external quality assessment (EQA) for HIV and syphilis testing in reference laboratories and their associated clinical sites in seven countries., Methods: HIV/syphilis serum liquid and dried tube specimen (DTS) panels were prepared by CDC. Liquid panels were distributed to the reference laboratories for three rounds of testing using commercially and locally available laboratory-based serological tests. DTS panels were sent to the clinical testing sites for 8 rounds of POC testing using the Abbott SD BIOLINE HIV/Syphilis Duo test (hereafter referred to as SD BIOLINE) and the Chembio Dual Path Platform (DPP) HIV-Syphilis assay. EQA panels were tested at CDC using the Rapid Plasma Reagin (RPR) test and the Treponema pallidum Particle Agglutination assay (TP-PA) for syphilis antibodies. Genetic Systems HIV-1/HIV-2 Plus O EIA, Geenius HIV Supplemental Assay and the Oraquick Advance HIV test were used to detect HIV antibodies in the EQA panels. Results from the reference laboratories and POCT sites were compared to those obtained at the CDC and a percentage agreement was calculated., Results: Qualitative RPR and TP-PA performed at the reference laboratories demonstrated 95.4-100% agreement with CDC results while quantitative RPR and TP-PA tests demonstrated 87.7% and 89.2% agreement, respectively. A 93.8% concordance rate was observed for qualitative HIV testing in laboratories. EQA testing at clinical sites using dual tests showed 98.7% and 99.1% agreement for detection of HIV antibodies and eight out of 10 sites had > 95.8% agreement for syphilis testing. However, two clinical sites showed only 65.0-66.7% agreement for SD BIOLINE and 84.0-86.7% for DPP, respectively, for syphilis testing., Conclusions: Overall, laboratories demonstrated high EQA performance in this study. Both HIV/syphilis POCTs gave expected results in the clinic-based evaluations using DTS. However, testing errors were identified in a few testing sites suggesting the necessity for continuous training and monitoring the quality of POC testing., (© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

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., (© 2024. The Author(s).)

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., (© 2024. The Author(s).)

Background: Sexually transmitted infections caused by Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) remain significant global health problems. The World Health Organization (WHO) has recently conducted a multi-faceted, multi-country validation study (ProSPeRo), which included an evaluation of the Xpert CT/NG and Xpert TV assays on the GeneXpert system (Cepheid, Sunnyvale, Ca., USA) in clinic-based settings across eight countries. To support the study, a training and quality management system was implemented and evaluated., Methods: A comprehensive training program for the study was developed. Quality control (QC) and external quality assessment (EQA) samples were provided by an accredited quality assurance provider. QC testing was conducted at 14 point-of-care testing (POCT) clinics, while EQA samples were tested by the POCT sites and a reference laboratory supporting each clinic., Results: For QC testing, concordance with the expected results for CT and NG was > 99% and rates of unsuccessful tests were < 4%. For TV testing, concordance was similar (97%), but rates of unsuccessful tests were high (18%), particularly in the 'TV negative' sample. For EQA testing initially conducted in 2018, concordance was 100% for CT and NG, and 90% for TV for the reference laboratory group (which used non-GeneXpert systems). Concordance for the POCT group was also high (> 94%) for all analytes, but this cohort (which used GeneXpert systems) exhibited a high rate of unsuccessful TV tests. All but one of these unsuccessful tests was subcategorised as 'invalid'., Conclusions: The high level of concordance for QC and EQA testing confirm that the trained operators at the POC clinical sites were competent to conduct POC testing and that the training and quality systems implemented for the ProSPeRo study were effective. The quality materials used were satisfactory for CT and NG but exhibited poor performance for TV testing on the GeneXpert system. The WHO should continue to work with industry and EQA providers to provide improved materials that are reliable, stable and cost effective for quality management, as it seeks to rollout molecular-based STI POCT in non-laboratory-based settings., Trial Registration: Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee., (© 2024. The Author(s).)

The prevalence of Mycoplasma genitalium (MG) and MG antimicrobial resistance (AMR) appear to be high internationally, however, prevalence data remain lacking globally. We evaluated the prevalence of MG and MG AMR-associated mutations in men who have sex with men (MSM) in Malta and Peru and women at-risk for sexually transmitted infections in Guatemala, South Africa, and Morocco; five countries in four WHO regions mostly lacking MG prevalence and AMR data, and estimated MG coinfections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Male urine and anorectal samples, and vaginal samples were tested for MG, CT, NG, and TV (only vaginal samples) using Aptima assays (Hologic). AMR-associated mutations in the MG 23S rRNA gene and parC gene were identified using ResistancePlus MG kit (SpeeDx) or Sanger sequencing. In total, 1,425 MSM and 1,398 women at-risk were recruited. MG was detected in 14.7% of MSM (10.0% in Malta and 20.0% Peru) and in 19.1% of women at-risk (12.4% in Guatemala, 16.0% Morocco, 22.1% South Africa). The prevalence of 23S rRNA and parC mutations among MSM was 68.1 and 29.0% (Malta), and 65.9 and 5.6% (Peru), respectively. Among women at-risk, 23S rRNA and parC mutations were revealed in 4.8 and 0% (Guatemala), 11.6 and 6.7% (Morocco), and 2.4 and 3.7% (South Africa), respectively. CT was the most frequent single coinfection with MG (in 2.6% of MSM and 4.5% of women at-risk), compared to NG + MG found in 1.3 and 1.0%, respectively, and TV + MG detected in 2.8% of women at-risk. In conclusion, MG is prevalent worldwide and enhanced aetiological MG diagnosis, linked to clinical routine detection of 23S rRNA mutations, in symptomatic patients should be implemented, where feasible. Surveillance of MG AMR and treatment outcome would be exceedingly valuable, nationally and internationally. High levels of AMR in MSM support avoiding screening for and treatment of MG in asymptomatic MSM and general population. Ultimately, novel therapeutic antimicrobials and/or strategies, such as resistance-guided sequential therapy, and ideally an effective MG vaccine are essential., Competing Interests: Hologic provided the Aptima M. genitalium, Aptima Combo 2, and Aptima T. vaginalis tests (special thanks to Philip Mueller and Damon Getman). However, no financial support for the testing was obtained, and Hologic had no role in data collection, analysis, interpretation or writing the paper., (Copyright © 2023 Shipitsyna, Kularatne, Golparian, Müller, Vargas, Hadad, Padovese, Hancali, Alvarez, Oumzil, Camey, Blondeel, Toskin and Unemo.)

Background: Current rapid tests for syphilis and yaws can detect treponemal and non-treponemal antibodies. We aimed to critically appraise the literature for rapid diagnostic tests (RDTs) which can better distinguish an active infection of syphilis or yaws., Methods: We conducted a systematic review and meta-analysis, searching five databases between January 2010 and October 2021 (with an update in July 2022). A generalised linear mixed model was used to conduct a bivariate meta-analysis for the pooled sensitivity and specificity. Heterogeneity was assessed using the I 2 statistic. We used the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) to assess the risk of bias and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) to evaluate the certainty of evidence., Results: We included 17 studies for meta-analyses. For syphilis, the pooled sensitivity and specificity of the treponemal component were 0.93 (95% CI: 0.86 to 0.97) and 0.98 (95% CI: 0.96 to 0.99), respectively. For the non-treponemal component, the pooled sensitivity and specificity were 0.90 (95% CI: 0.82 to 0.95) and 0.97 (95% CI: 0.92 to 0.99), respectively. For yaws, the pooled sensitivity and specificity of the treponemal component were 0.86 (95% CI: 0.66 to 0.95) and 0.97 (95% CI: 0.94 to 0.99), respectively. For the non-treponemal component, the pooled sensitivity and specificity were 0.80 (95% CI: 0.55 to 0.93) and 0.96 (95% CI: 0.92 to 0.98), respectively., Conclusions: RDTs that can differentiate between active and previously treated infections could optimise management by providing same-day treatment and reducing unnecessary treatment., Prospero Registration Number: CRD42021279587., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Biomedical science is rapidly developing in terms of more transparency, openness and reproducibility of scientific publications. This is even more important for all studies that are based on results from basic semen examination. Recently two concordant documents have been published: the 6th edition of the WHO Laboratory Manual for the Examination and Processing of Human Semen, and the International Standard ISO 23162:2021. With these tools, we propose that authors should be instructed to follow these laboratory methods in order to publish studies in peer-reviewed journals, preferable by using a checklist as suggested in an Appendix to this article., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Over the past 40 years, since the publication of the original WHO Laboratory Manual for the Examination and Processing of Human Semen, the laboratory methods used to evaluate semen markedly changed and benefited from improved precision and accuracy, as well as the development of new tests and improved, standardized methodologies. Herein, we present the impact of the changes put forth in the sixth edition together with our views of evolving technologies that may change the methods used for the routine semen analysis, up-and-coming areas for the development of new procedures, and diagnostic approaches that will help to extend the often-descriptive interpretations of several commonly performed semen tests that promise to provide etiologies for the abnormal semen parameters observed. As we look toward the publication of the seventh edition of the manual in approximately 10 years, we describe potential advances that could markedly impact the field of andrology in the future., (Copyright © 2021 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

As stated clearly in all editions of the WHO Laboratory Manual for the Examination and Processing of Human Semen, the goal of the manual is to meet the growing needs for the standardization of semen analysis procedures. With constant advances in andrology and reproductive medicine and the advent of sophisticated assisted reproductive technologies for the treatment of infertility, the manual has been continuously updated to meet the need for new, evidence-based, validated tests to not only measure semen and sperm variables but also to provide a functional assessment of spermatozoa. The sixth edition of the WHO manual, launched in 2021, can be freely downloaded from the WHO website, with the hope of gaining wide acceptance and utilization as the essential source of the latest, evidence-based information for laboratory procedures required for the assessment of male reproductive function and health., (Copyright © 2021 American Society for Reproductive Medicine. All rights reserved.)

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., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.)

Background: Brief interventions have proven to be valuable instruments for the treatment and care of clients with diverse health needs, due to their potential to impact both the individual and the population. In this regard, the Brief Sexuality-Related Communication (BSC) is presented as a viable and effective alternative for addressing sexual and reproductive health problems, assessing risk behaviors and motivating clients to generate behavioral change. Since health providers are key actors in treatment and prevention, it is essential to know their perceptions about the BSC intervention, as well as its acceptability in different contexts, with diverse client populations. Thus, the following paper reflects the findings of the perceptions and experiences of health providers in Peru from the first phase of the Feasibility study of a BSC intervention to prevent STIs and unintended pregnancies., Methods: This is the first phase of a multisite and multiphase study of the feasibility of a BSC intervention. We conducted twenty in-depth interviews (IDI) with health care providers (physicians, obstetricians, psychologists, nurses and peer counselors) recruited from three health care institutions in Peru: The Tahuantinsuyo Bajo Maternal and Child Center (CMI) and the San José Maternal and Child Center, both located in the capital city, Lima; and La Caleta Hospital located in Chimbote, northern coast of Peru. Participating health providers included those working at the HIV/STI Reference service and the family planning/reproductive health service. The IDI addressed three domains: 1) Acceptability of the BSC intervention; 2) Perceived willingness to implement the BSC intervention; and 3) Considerations for the Implementation of the BSC intervention., Results: Health providers expressed high acceptance of the BSC intervention, considering it as a useful and effective instrument to address sexual and reproductive health problems with all clients; however, some providers had some concerns about the real impact of the intervention to achieve significant behavior change. On the other hand, health providers showed high willingness to learn and implement the BSC intervention, affirming their commitment to learn new techniques and strategies that could allow them to improve their knowledge and the quality of their care. Health care providers consider it necessary to take into account the barriers that arise in the implementation of the BSC intervention, such as the structural limitations to access, the providers' abilities to deliver the intervention effectively, and the participants' reception of the intervention. Finally, providers consider it essential to establish the BSC intervention in a normative framework that allows it to receive the support of the health departments and eventually enforces implementation., Conclusions: Health providers consider the BSC intervention as an interesting and exciting behavioral intervention to deal with the sexual and reproductive health issues existing in different populations, and seemed highly willing to adapt and implement it, hoping that it become beneficial to all client populations to prevent HIV/STIs and unintended pregnancies., (© 2021. The Author(s).)

Background: Brief behavioral interventions are seen as an efficient way to improve knowledge, change behavior, and reduce provider stigma regarding sexual health. When grounded in evidence-based behavioral change techniques and delivered using Brief Sexuality-related Communication (BSC) tools, brief behavioral interventions can address client-driven sexual health goals in a single session with their provider. Evidence for the efficacy of brief interventions for creating gains in sexual health comes largely from resource rich settings, and there is a lack of knowledge of how brief interventions can be implemented in the more resource constrained environments of low- and middle-income countries. As a first step in developing a brief intervention to address sexual health issues in Moldova, this paper reports on qualitative data collected from Moldovan providers to understand their attitudes, willingness and perceived barriers to the brief intervention and its implementation., Methods: Thirty-nine in-depth interviews (IDI) were conducted between February and March 2020, with health providers recruited from three primary health care institutions, two Youth Friendly Health Centers and counselors from three NGOs who work with key populations in Moldova, including health centers selected from two cites - the capital city, Chisinau and from the Comrat Region. The IDI addressed four domains of provider attitudes: 1) attitudes towards the intervention; 2) willingness and motivation to implement the intervention; 3) logistics of providing the intervention and 4) ability to implement the intervention. A coding analysis approach was applied to all interview transcripts., Results: Providers largely reported being willing to be trained in and implement the brief intervention. Willingness to implement the intervention stemmed from two perceptions: that it would improve the ability of providers to talk with their clients about sex, and that vulnerable groups would benefit from these conversations. However, while there were generally positive attitudes towards the intervention, providers consistently reported structural barriers to their perceived ability to implement the intervention., Conclusions: While providers reported high levels of initial acceptance of a brief behavioral intervention, care is needed to ensure that brief interventions, and the training of providers on brief interventions, incorporate cultural attitudes and norms around sex, particularly in highly patriarchal settings, and provide opportunities for providers to practice the intervention in ways that address their assumptions and implicit biases., (© 2021. The Author(s).)

Background: It is now 11 years since publication of the WHO 2010 guidelines for semen assessment values, and it is critical to determine whether they are still valid and/or whether they should be modified., Objectives: To utilise data published since 2010 and combine these with data used in the 2010 assessment to provide an updated and more comprehensive representation of the fertile man. This may be utilised to present an updated distribution of values for use by WHO in 2021., Materials and Methods: Two specific analyses were performed namely, (1) Analysis 1: Examination of published data following publication of WHO 2010 [termed 2010-2020 data]. (2) Analysis 2: Examination of the data used to help formulate the 2010 distribution of values combined with the data from Analysis (1) [termed WHO 2020]., Results: In total, data from more than 3500 subjects, from twelve countries and five continents were analysed. The 5 th centile values for concentration, motility and morphology are: 16 × 10 6 /ml, 30% progressive motility [42% total motility] and 4% normal forms., Discussion: This study presents substantial additional information to establish more comprehensive and globally applicable lower reference values for semen parameters for fertile men although they do not represent distinct limits between fertile and subfertile men. There are still data missing from many countries and, some geographical regions are not represented. Moreover, the number of subjects although significant is still relatively low (<4000)., Conclusion: These distributions of values now include semen analysis providing a more global representation of the fertile man. Increasing the number of subjects provides robust information that is also more geographically representative., (© 2021 American Society of Andrology and European Academy of Andrology.)

Objective: To provide an in-depth systematic assessment of the global epidemiology of gonorrhoea infection in infertile populations., Methods: A systematic literature review was conducted up to 29 April 2019 on international databases and WHO regional databases, and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All prevalence measures of gonorrhoea infection among infertile populations, based on primary data, qualified for inclusion. Infertile populations were broadly defined to encompass women/men undergoing infertility evaluation or treatment (infertility clinic attendees and partners). Pooled mean prevalence by relevant strata was estimated using random-effects meta-analysis. Associations with prevalence and sources of heterogeneity were explored using metaregression. Risk of bias was assessed using four quality domains., Findings: A total of 147 gonorrhoea prevalence studies were identified from 56 countries. The pooled mean prevalence of current gonorrhoea infection was estimated globally at 2.2% (95% CI 1.3% to 3.2%), with the highest prevalence in Africa at 5.0% (95% CI 1.9% to 9.3%). The mean prevalence was higher for populations with tubal factor infertility (3.6%, 95% CI 0.9%-7.7%) and mixed cause and unexplained infertility (3.6%, 95% CI 0.0% to 11.6%) compared with other diagnoses, such as ovarian and non-tubal infertility (0.1%, 95% CI 0.0% to 0.8%), and for secondary (2.5%, 95% CI 0.2% to 6.5%) compared with primary (0.5%, 95% CI 0.0% to 1.7%) infertility. Metaregression identified evidence of variations in prevalence by region and by infertility diagnosis, higher prevalence in women than men and a small-study effect. There was a trend of declining prevalence by about 3% per year over the last four decades (OR=0.97, 95% CI 0.95 to 0.99)., Conclusions: Gonorrhoea prevalence in infertile populations is several folds higher than that in the general population, with even higher prevalence in women with tubal factor infertility and in individuals with secondary infertility. These findings support the potential role of gonorrhoea in infertility and suggest that some infertility is possibly preventable by controlling gonorrhoea transmission., Prospero Registration Number: CRD42018102934., Competing Interests: Competing interests: The authors have no conflicts of interests to declare., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Data for MSM continue to show a high risk of acquiring HIV-STIs. Within this population, outness seems to have an impact on both risk-taking and on health seeking behaviors. The objective of this study was to assess the relationship between socio-demographic, behavioral characteristics, testing behaviors, and outness level among MSM using data from a multi-center bio-behavioral cross-sectional study carried out in 13 EU cities. A multilevel analysis was conducted to identify factors associated with being open ("out") versus not being open ("in"). A total of 4,901 MSM were enrolled in the study and were classified as "out" in 71% of the cases. MSM "out" were more likely to report HIV testing and being reached by HIV prevention programs compared to MSM who were "in." The results confirm the key role of outness in relation to different healthy and risky behavior, ranging from testing to party-drug use.

Background: Infertility affects 48.5 million couples worldwide with a prevalence estimated at 3.5-16.7% in low- and middle-income countries (LMIC), and as high as 30-40% in Sub-Saharan Africa. ART services are not accessible to the majority of these infertile couples due to the high cost of treatments in addition to cultural, religious and legal barriers. Infertility and childlessness, particularly in LMIC, have devastating consequences, which has resulted in considerable interest in developing affordable IVF procedures. However, there is a paucity of evidence on the safety, efficiency and ability to replicate techniques under different field conditions, and how to integrate more affordable ART options into existing infrastructures., Objective and Rationale: This review was performed to investigate the current availability of IVF in LMIC and which other ART options are under development. This work will unfold the landscape of available and potential ART services in LMIC and is a key element in positioning infertility more broadly in the Global Public Health Agenda., Search Methods: A systematic literature search was performed of articles and gray literature on IVF and other ART options in LMIC published between January 2010 and January 2020. We selected studies on IVF and other ART treatments for infertile couples of reproductive age (18-44 years) from LMIC. The review was limited to articles published after 2010, based on the recent evolution in the field of ART practices in LMIC over the last decade. Citations from high-income countries, including data prior to 2010 and focusing on specialized ART procedures, were excluded. The literature search included PubMed, Popline, CINHAL, EMBASE and Global Index Medicus. No restrictions were applied with regard to study design or language. Two reviewers independently screened the titles and abstracts, and extracted data. A search for gray literature was performed using the 'Google' search engine and specific databases (worldcat.org, greylit.org). In addition, the reference lists of included studies were assessed., Outcomes: The search of the electronic databases yielded 3769 citations. After review of the titles and abstracts, 283 studies were included. The full texts were reviewed and a further 199 articles were excluded. The gray literature search yielded 586 citations, most of which were excluded after screening the title, and the remaining documents were excluded after full-text assessment due to duplicate entries, not from LMIC, not relevant or no access to the full document. Eighty-four citations were included as part of the review and separated into regions. The majority of the studies were observational and qualitative studies. In general, ART services are available and described in several LMIC, ranging from advanced techniques in China to basic introduction of IVF in some African countries. Efforts to provide affordable ART treatments are described in feasibility studies and efficacy studies; however, most citations were of low to very low quality. We found no studies from LMIC reporting the implementation of low-cost ART that is effective, accessible and affordable to most of those in need of the services., Wider Implications: The World Health Organization is in a unique position to provide much needed guidance for infertility management in LMIC. This review provides insight into the landscape of ART in LMIC in various regions worldwide, which will guide efforts to improve the availability, quality, accessibility and acceptability of biomedical infertility care, including ART in these countries., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Objectives: Portugal has the highest HIV incidence rate in Western Europe. The proportion assigned to sexual contact between men recently increased to more than 30% of all HIV infections. Men who have sex with men (MSM) are vulnerable to the acquisition of other sexually transmitted infections (STIs), increasing the per-contact risk of HIV infection. Building on syndemic theory, the aim of this analysis was to identify patterns of current sexual behaviour in MSM, and explore their relationship with self-reported current, past STI diagnoses and HIV positive serostatus., Design: A cross-sectional behavioural survey was conducted in Portugal among MSM, using a community-based participatory research approach. Hierarchical cluster analysis was used to identify patterns including behavioural and demographic factors., Results: The analysis resulted in six clusters. Three clusters showed higher rates of current STI diagnosis (ranging from 11.7% to 17.1%), past STI diagnosis (ranging from 25.5% to 41.5%) and HIV positive serostatus (ranging from 13.0% to 16.7%). From the three clusters scoring lower on current and past STI and HIV diagnoses, one was characterised by a high number of sexual partners (62% had more than 12 partners in the last year), a high proportion (94.6%) of frequent visits to gay venues to meet sexual partners and high alcohol use (46.1%). The other two clusters scored lower on high risk sexual behaviour., Conclusion: Factors other than sexual behaviour appear to reinforce the vulnerability to STIs and HIV of some MSM in this study, suggesting a syndemic of STIs, HIV and other adverse conditions. More research is needed to better understand the drivers of the STI/HIV epidemic in Portuguese MSM, using a concept that goes beyond risk behaviour, to develop effective combination prevention interventions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The psoriasis is chronic inflammatory dermatitis that is accompanied by severe damage of skin and musculoskeletal system and affects functions of other organs and systems. The epidemiological data concerning prevalence and morbidity of psoriasis all over the world varies significantly. The article presents comparative characteristic of approaches to monitoring and evaluation of psoriasis morbidity in the Russian Federation and in the countries of the European region. The differences were revealed such as absence both of indices to evaluate quality of life of patients with psoriasis and specific population epidemiological studies in national system of monitoring and evaluation of the Russian Federation.

Background: Available studies on the prevalence of infertility have proved to have certain limitations, with a scarcity of population-based studies and inconsistent reporting from surveys in countries at all income levels. We wanted to test the applicability of the current duration approach to data from the important Demographic and Health Surveys (DHS) program, funded by USAID since its inception in 1985, https://dhsprogram.com/., Methods: The current duration approach assumes that there is a well-defined time of initiation of attempts to get pregnant and defines the current duration of a still ongoing pregnancy attempt as the time interval from initiation to interview. The DHS interviews do not have an explicit question about initiation. We focused on nullipari and substituted date of "establishment of relationship with current partner" for initiation. Our study used the current duration approach on 15 datasets from DHS during 2002-2016 in eight different countries from sub-Saharan Africa, Asia, and Latin America., Results: Well-established statistical techniques for current duration data yielded results that for some countries postulated surprisingly long median times to pregnancy and surprisingly high estimates of infertility prevalence. Further study of the data structures revealed serious deviations from expected patterns, in contrast to our earlier experience from surveys in France and the United States where participants were asked explicitly about time of initiation of attempts to become pregnant., Conclusions: Using cohabitation as a proxy for the initiation of attempts to get pregnant is too crude. Using the current duration approach with DHS data will require more explicit questions during the DHS interviews about initiation of pregnancy attempt.