Standardised protocol for a prospective international multicentre clinical-based evaluation of point-of-care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial, gonococcal and Trichomonas vaginalis infections in at risk women.

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.

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.

Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial.

INTRODUCTION: ONCO-TreC platform consists of a mobile application delivered to patients as electronic diary and a web-based dashboard managed by healthcare professionals. We aim to compare the effectiveness of ONCO-TreC electronic diary with a standard paper diary, in improving adherence to oral cancer therapy in patients with solid and haematological tumours. METHODS AND ANALYSIS: This is an open label, superiority, randomised controlled trial conducted in two Italian oncology units. Patients will be randomised with a 1:1 ratio to electronic or paper diary. For both groups a counsellor will be responsible for drug and diary delivery. The evaluation period will end after six cycles of therapy. The primary aim is to compare the proportion of non-adherent patients in the two arms. Adherence will be measured through pill count; anyone who takes less than 90% of the total prescribed drug dose will be considered non-adherent. Assuming a percentage of non-adherent patients to oral therapy of 40% in arm B, and a 60% reduction in this percentage in arm A, a sample of 124 patients will provide 80% power to identify an absolute difference greater than 24 percentage points using a bilateral Fisher's exact test with a significance level of 0.05. Considering a dropout rate of 10%, approximately 136 patients will have to be enrolled. The primary analysis will be performed on the intention-to-treat population. Secondary aims are to describe the reasons for non-adherence, the level of satisfaction of patients and healthcare professionals with the paper and electronic diary, and the impact of non-adherence in terms of healthcare costs. ETHICS AND DISSEMINATION: Ethical approval was obtained from Romagna Ethics Committee (CEROM), study ID 2108, prot. n. IRST 100.28 of 10/04/2020. Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. PROTOCOL VERSION: Version 2, 6 April 2021. TRIAL REGISTRATION NUMBER: NCT04826458.

Enabling teleophthalmology during the COVID-19 pandemic in the Province of Trento, Italy: Design and implementation of a mHealth solution.

BACKGROUND: Due to the many restrictions imposed during the COVID-19 emergency, the normal clinical activities have been stopped abruptly in view of limiting the circulation of the virus. The extraordinary containment measures have had a dramatic impact on the undertaking and follow-up of ophthalmic outpatients. OBJECTIVE: In order to guarantee proper monitoring and routine care, the Pediatric Ophthalmology equipe of Rovereto Hospital (North-East of Italy) supported by the Competence Center on Digital Health TrentinoSalute4.0, designed and implemented a digital platform, TreC Oculistica, enabling teleophthalmology. We report our innovative-albeit restricted-experience aiming at testing and maximizing the efficacy of remote ophthalmic and orthoptic visits. METHODS: A multidisciplinary team created the TreC Oculistica platform and defined a teleophthalmology protocol. The system consists of a clinician web interface and a patient mobile application. Clinicians can prescribe outpatients with the App and some preliminary measurements to be self-collected before the televisit. The App conveys the clinician's requests (i.e. measurements) and eases the share of the collected information in a secure digital environment, promoting a new health care workflow. RESULTS: Four clinicians took part in the testing phase (2 ophthalmologists and 2 orthoptists) and recruited 37 patients (mostly pediatric) in 3 months. Thanks to a continuous feedback between the testing and the technical implementation, it has been possible to identify pros and cons of the implemented functionalities, considering possible improvements. Digital solutions such as TreC Oculistica advance the digitalization of the Italian health care system, promoting a structured and effective reorganization of the workload supported by digital systems. CONCLUSIONS: The study tested an innovative digital solution in the teleophthalmology context and represented the first experience within the Italian healthcare system. This solution opens up new possibilities and scenarios that can be effective not only during the pandemic, but also in the traditional management of public health services.

Changes in the prevalence of self-reported sexually transmitted bacterial infections from 2010 and 2017 in two large European samples of men having sex with men-is it time to re-evaluate STI-screening as a control strategy?

BACKGROUND/OBJECTIVES: Many European countries reported increased numbers of syphilis, gonorrhoea and chlamydia diagnoses among men who have sex with men (MSM) in recent years. Behaviour changes and increased testing are thought to drive these increases. METHODS: In 2010 and 2017, two large online surveys for MSM in Europe (EMIS-2010, EMIS-2017) collected self-reported data on STI diagnoses in the previous 12 months, diagnostic procedures, STI symptoms when testing, number of sexual partners, and sexual behaviours such as condom use during the last intercourse with a non-steady partner in 46 European countries. Multivariate regression models were used to analyse factors associated with diagnoses of syphilis, gonorrhoea/chlamydia, and respective diagnoses classified as symptomatic and asymptomatic. If applicable, they included country-level screening rates. RESULTS: Questions on STI diagnoses and sexual behaviours were answered by 156,018 (2010) and 125,837 (2017) participants. Between 2010 and 2017, overall diagnoses with gonorrhoea/chlamydia and syphilis increased by 76% and 83% across countries. Increases were more pronounced for asymptomatic compared to symptomatic infections. The proportion of respondents screened and the frequency of screening grew considerably. Condomless anal intercourse with the last non-steady partner rose by 62%; self-reported partner numbers grew. Increased syphilis diagnoses were largely explained by behavioural changes (including more frequent screening). Gonorrhoea/chlamydia increases were mainly explained by more screening and a change in testing performance. A country variable representing the proportion of men screened for asymptomatic infection was positively associated with reporting symptomatic gonorrhoea/chlamydia, but not syphilis. DISCUSSION/CONCLUSION: The positive association of country-level screening rates with the proportion of symptomatic infections with gonorrhoea/chlamydia may indicate a paradoxical effect of screening on incidence of symptomatic infections. Treatment of asymptomatic men might render them more susceptible to new infections, while spontaneous clearance may result in reduced susceptibility. Before expanding screening programmes, evidence of the effects of screening and treatment is warranted.

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.

Psychosocial correlates of HIV testing among men who have sex with men in Italy: a cross-sectional study.

The objective of this study was to understand the psychosocial correlates of men having sex with men (MSM) who have never been tested (never testers), MSM who have been tested in the last 12 months (recent testers), and MSM who have been tested before (remote testers). A sample of 14,409 Italian HIV-negative adult MSM was recruited via instant messages to the members of five international commercial websites and through clickable banner advertisements on different websites. The most important correlates of never testers compared to recent testers were younger age, sexual orientation concealment, unawareness of free HIV services, having had a partner of unknown serostatus, and lower levels of HIV testing self-efficacy (i.e. the belief in one's own ability to get a test for HIV). The most important correlates of remote testers compared to recent testers were older age, homosexual orientation, having had a partner of unknown serostatus, unawareness of free HIV services, and lower level of HIV testing self-efficacy. There are different psychosocial correlates of MSM based on HIV testing history. Based on the findings of this study, prevention efforts should be directed toward increasing awareness about the availability of HIV testing services and HIV testing self-efficacy among MSM.