Igor Toskin

Evidence and knowledge gaps on the disease burden in sexual and gender minorities: a review of systematic reviews.

Sexual and gender minorities (SGM) include individuals with a wide range of sexual orientations, physical characteristics, and gender identities and expressions. Data suggest that people in this group face a significant and poorly understood set of additional health risks and bear a higher burden of some diseases compared to the general population. A large amount of data is available on HIV/AIDS, but far less on other health problems. In this review we aimed to synthesize the knowledge on the burden of communicable and non-communicable diseases, mental health conditions and violence experienced by SGM, based on available systematic reviews. We conducted a global review of systematic reviews, including searching the Cochrane and the Campbell Collaboration libraries, as well as PubMed, using a range of search terms describing the populations of interest, without time or language restrictions. Google Scholar was also scanned for unpublished literature, and references of all selected reviews were checked to identify further relevant articles. We found 30 systematic reviews, all originally written in English. Nine reviews provided data on HIV, 12 on other sexually transmitted infections (STIs), 4 on cancer, 4 on violence and 3 on mental health and substance use. A quantitative meta-analysis was not possible. The findings are presented in a narrative format. Our review primarily showed that there is a high burden of disease for certain subpopulations of SGM in HIV, STIs, STI-related cancers and mental health conditions, and that they also face high rates of violence. Secondly, our review revealed many knowledge gaps. Those gaps partly stem from a lack of original research, but there is an equally urgent need to conduct systematic and literature reviews to assess what we already know on the disease burden in SGM. Additional reviews are needed on the non-biological factors that could contribute to the higher disease burden. In addition, to provide universal access to health-care for all, more information is needed on the barriers that SGM face in accessing health services, including the attitudes of health-care providers. Understanding these barriers and the additional health risks they impose is crucial to improving the health status of SGM.

Brief sexuality communication—a behavioural intervention to advance sexually transmitted infection/HIV prevention: a systematic review

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.

A systematic review and meta-analysis of studies evaluating the performance and operational characteristics of dual point-of-care tests for HIV and syphilis

Background Mother-to-child transmission (MTCT) of syphilis and HIV continue to be important yet preventable causes of perinatal and infant morbidity and mortality. Objectives To systematically review, critically appraise and perform a meta-analysis to evaluate the operational characteristics of dual rapid diagnostic tests (RDTs) for HIV/syphilis and evaluate whether they are cost effective, acceptable and easy to use. Design Systematic review and meta-analysis. Data sources We searched seven electronic bibliographic databases from 2012 to December 2016 with no language restrictions. Search keywords included HIV, syphilis and diagnosis. Review methods We included studies that evaluated the operational characteristics of dual HIV/syphilis RDTs. Outcomes included diagnostic test accuracy, cost effectiveness, ease of use and interpretation and acceptability. All studies were assessed against quality criteria and assessed for risk of bias. Results Of 1914 identified papers, 18 were included for the meta-analysis of diagnostic accuracy for HIV and syphilis. All diagnostic accuracy evaluation studies showed a very high sensitivity and specificity for HIV and a lower, yet adequate, sensitivity and specificity for syphilis, with some variation among types of test. Dual screening for HIV and syphilis was more cost effective than single rapid tests for HIV and syphilis and prevented more adverse pregnancy outcomes. Qualitative data suggested dual RDTs were highly acceptable to clients, who cited time to result, cost and the requirement of a single finger prick as important characteristics of dual RDTs. Conclusion The results of this systematic review and meta-analysis can be used by policy-makers and national programme managers who are considering implementing dual RDTs for HIV and syphilis. Trial registration number PROSPERO 2016:CRD42016049168.

Using electronic readers to monitor progress toward elimination of mother‐to‐child transmission of HIV and syphilis: An opinion piece

Electronic readers and smartphones have the potential to standardize the interpretation of rapid diagnostic tests (RDTs) and provide timely surveillance program data. RDTs are widely used for HIV and are being increasingly used for syphilis screening in pregnant women. Following the WHO initiative for the validation of elimination of mother‐to‐child transmission of HIV and syphilis, there is a need for more extensive testing and data monitoring. However, access to timely and accurate data can be challenging once testing is decentralized as data quality at remote sites is often difficult to verify. Electronic RDT readers can help to ensure quality and allow automated data transmission, creating an opportunity for real‐time surveillance to inform control strategies and assess intervention impact. Furthermore, by linking the data to existing supply chain management software, stockouts can be minimized. The present opinion piece looks at the opportunities and challenges of using these tools within national elimination programs.

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

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

Performance and operational characteristics of point-of-care tests for the diagnosis of urogenital gonococcal infections

Background In 2012, there was an estimated 78 million new cases of gonorrhoea globally. Untreated infection may lead to reproductive and neonatal morbidity and facilitate HIV transmission. Diagnosis and treatment are a priority for control and prevention, yet use of point-of-care tests (POCTs) for Neisseria gonorrhoeae (NG) is limited. Objectives To review the performance and operational characteristics of NG POCTs for diagnosis of urogenital gonorrhoea. Methods We compiled and synthesised findings from two separate systematic reviews which included evaluations published until August 2015. Results Six tests were included: five were immunochromatographic tests (ICTs) or optical immunoassay (OIAs) based on antigen detection; with 5–7 steps and results in 25–40 min, and one (GeneXpert CT/NG) was a ‘near-patient test’ based on nucleic acid amplification technique (NAAT); with three steps, electricity required, and results in 90 min. When compared with laboratory-based NAATs as the reference tests, sensitivities of ICT and OIA-based POCTs ranged from 12.5% to 70% when cervical/vaginal swabs were tested. Specificities ranged from 89% to 99.8%. The near-patient NAAT had sensitivities of >95% and specificities of >99.8% consistently across all specimen types (urine, cervical and vaginal swabs). Conclusions Based on a limited number of evaluations, antigen detection POCTs for NG lacked sufficient sensitivity to be used for screening. A near-patient NAAT has acceptable performance, only involved a few steps, but needs electricity, a temperature-controlled environment and has a 90 min run time. To achieve wider scale up of NG POCTs, we need strong evidence of cost-effectiveness, which should inform guidelines and ultimately increase test development, demand and reduce costs.

Socio-demographic Characteristics, Sexual and Test-Seeking Behaviours Amongst Men Who have Sex with Both Men and Women: Results from a Bio-behavioural Survey in 13 European Cities

Within the MSM population, men who have sex with both men and women (MSMW) are identified as a high-risk group both worldwide and in Europe. In a multi-centred bio-behavioural cross-sectional study, we aimed to assess the relationship(s) between socio-demographic factors, stigma, sexual behavioural patterns, test seeking behaviour and sero-status amongst MSMW. A multi-level analysis was conducted to identify factors associated with being MSMW versus Men who have Sex with Men Only (MSMO). A total of 4901 MSM were enrolled across the 13 study sites. Participants were categorised as MSMW in the 12.64% of the cases. Factors such as educational status, perceived homonegativity, testing facilities knowledge and HIV testing lifetime seem to be relevant factors when characterising the MSMW group. The results highlight the vulnerability of MSMW and the wide spectrum of risky behavioural and psycho-social patterns, particularly in terms of HIV testing, ‘outness’, and perceived stigma.ResumenLos Hombres que tienen Sexo con Hombres y Mujeres (HSHM) son un grupo de población de alto riesgo dentro de los HSH. Evaluar la relación entre factores socio-demográficos, estigma, patrones de conducta sexual y de búsqueda de la prueba y el estado serológico de los HSHM. Estudio bio-conductual multicéntrico transversal. Análisis multinivel para identificar factores asociados con ser HSHM respecto a los Hombres que Sólo tienen Sexo con Hombres. Se reclutaron 4.901 HSH en 13 ciudades, siendo un 12,64% HSHM. El nivel educativo, la homonegatividad percibida, el conocimiento de los lugares de realización de la prueba y la prueba del VIH alguna vez son factores relevantes para caracterizar los HSHM. Los resultados subrayan la vulnerabilidad de los HSHM y la diversidad de conductas y patrones psicosociales de riesgo, particularmente en términos de la prueba del VIH, visibilidad de la identidad sexual y estigma percibido.

Advancing prevention of sexually transmitted infections through point-of-care testing: target product profiles and landscape analysis

Objectives Advancing the field of point-of-care testing (POCT) for STIs can rapidly and substantially improve STI control and prevention by providing targeted, essential STI services (case detection and screening). POCT enables definitive diagnosis and appropriate treatment in a single visit and home and community-based testing. Methods Since 2014, the WHO Department of Reproductive Health and Research, in collaboration with technical partners, has completed four landscape analyses of promising diagnostics for use at or near the point of patient care to detect syphilis, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and the human papillomavirus. The analyses comprised a literature review and interviews. Two International Technical Consultations on STI POCTs (2014 and 2015) resulted in the development of target product profiles (TPP). Experts in STI microbiology, laboratory diagnostics, clinical management, public health and epidemiology participated in the consultations with representation from all WHO regions. Results The landscape analysis identified diagnostic tests that are either available on the market, to be released in the near future or in the pipeline. The TPPs specify 28 analytical and operational characteristics of POCTs for use in different populations for surveillance, screening and case management. None of the tests that were identified in the landscape analysis met all of the targets of the TPPs. Conclusion More efforts of the global health community are needed to accelerate access to affordable quality-assured STI POCTs, particularly in low- and middle-income countries, by supporting the development of new diagnostic platforms as well as strengthening the validation and implementation of existing diagnostics according to internationally endorsed standards and the best available evidence.

Field evaluation of two point-of-care tests for syphilis among men who have sex with men, Verona, Italy

Objectives The incidence of HIV and syphilis among men who have sex with men (MSM) in Europe has recently increased. Rapid point-of-care tests (POCTs) for syphilis can improve access to screening. The purpose of this study was to evaluate the performance of two syphilis POCTs compared with laboratory tests among MSM. Methods The study was undertaken in Verona, Italy. Asymptomatic MSM, potentially exposed to syphilis, were enrolled prospectively. The POCTs evaluated were SD Bioline Syphilis 3.0 and Chembio DPP Syphilis Screen & Confirm Assay on both serum and fingerprick blood. The results of the POCTs were read by the naked eye by two independent readers and their concordance assessed. Results A total of 289 MSM were enrolled in the study. Based on laboratory tests, 35 MSM (12.1%) were TPPA-positive alone and 16 (5.5%) were both Treponema pallidum particle agglutination test (TPPA) and rapid plasma reagin (RPR)-positive. The specificities of both POCTs were above 99% on both serum and fingerstick blood specimens, while sensitivities varied considerably. The sensitivity of the SD Bioline test was lower on fingerprick blood (51.4% and 54.3%, readers 1 and 2, respectively) compared with that on serum (80.0% and 82.9%). In contrast, the Chembio test exhibited similar sensitivity values for serum and fingerprick samples (57.7% and 64.0% on serum vs 65.4% and 69.2% on fingerprick for the treponemal component; 63.6% on both samples by both readers for the non-treponemal component). The positive predictive value ranged between 100% and 93.9% for the treponemal component of both syphilis POCTs, but was lower (76.3%–100%)%) for the non-treponemal component of the Chembio POCT. The negative predictive value surpassed 90% for both tests on both samples. The agreement between readers was very high (>99%). Conclusion The diagnostic performance of the syphilis POCTs was lower than expected; however, considering the prevalence of syphilis among MSM, POCTs should be recommended to improve syphilis detection among MSM.

Systematic reviews of point-of-care tests for the diagnosis of urogenital Chlamydia trachomatis infections

Background WHO estimates that 131 million new cases of urogenital Chlamydia trachomatis (CT) infections occur globally every year. Most infections are asymptomatic. Untreated infection in women can lead to severe complications. Screening and treatment of at-risk populations is a priority for prevention and control. Objectives To summarise systematic reviews of the performance characteristics of commercially available point-of-care tests (POCT) for screening and diagnosis of urogenital CT infection. Methods Two separate systematic reviews covering the periods 2004–2013 and 2010–2015 were conducted on rapid CT POCTs. Studies were included if tests were evaluated against a valid reference standard. Results In the first review, 635 articles were identified, of which 11 were included. Nine studies evaluated the performance of eight antigen detection rapid POCTs on 10 280 patients and two studies evaluated a near-patient nucleic acid amplification test (NAAT) on 3518 patients. Pooled sensitivity of antigen detection tests was 53%, 37% and 63% for cervical swabs, vaginal swabs and male urine, and specificity was 99%, 97% and 98%, respectively. The pooled sensitivity and specificity of the near-patient NAAT for all specimen types were >98% and 99.4%, respectively. The second review identified two additional studies on four antigen detection POCTs with sensitivities and specificities of 22.7%–37.7% and 99.4%–100%, respectively. A new two-step 15 min rapid POCT using fluorescent nanoparticles showed performance comparable to that of near-patient NAATs. Conclusions The systematic reviews showed that antigen detection POCTs for CT, although easy to use, lacked sufficient sensitivity to be recommended as a screening test. A near-patient NAAT shows acceptable performance as a screening or diagnostic test but requires electricity, takes 90 min and is costly. More affordable POCTs are in development.