Sexual satisfaction, an indicator of sexual health and well-being? Insights from STI/HIV prevention research in European men who have sex with men.

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.

A Mindfulness-Based App Intervention for Pregnant Women: Protocol for a Pilot Feasibility Study.

BACKGROUND: Pregnancy is a complex time characterized by major transformations in a woman, which impact her physical, mental, and social well-being. How a woman adapts to these changes can affect her quality of life and psychological well-being. The literature indicates that pregnant women commonly experience psychological symptoms, with anxiety, stress, and depression being among the most frequent. Hence, promoting a healthy lifestyle focused on women's psychological well-being is crucial. Recently developed digital solutions have assumed a crucial role in supporting psychological well-being in physiologically pregnant women. Therefore, the need becomes evident for the development and implementation of digital solutions, such as a virtual coach implemented in a smartphone, as a support for the psychological well-being of pregnant women who do not present psychological and psychiatric disorders. OBJECTIVE: This study aims to assess the feasibility, acceptability, and utility of a mindfulness-based mobile app. The primary objective is to explore the feasibility of using a virtual coach, Maia, developed within the TreC Mamma app to promote women's psychological well-being during pregnancy through a psychoeducational module based on mindfulness. Finally, through the delivery of this module, the level of psychological well-being will be explored as a secondary objective. METHODS: This is a proof-of-concept study in which a small sample (N=50) is sufficient to achieve the intended purposes. Recruitment will occur within the group of pregnant women belonging to the pregnancy care services of the Trento Azienda Provinciale per i Servizi Sanitari di Trento. The convenience sampling method will be used. Maia will interact with the participating women for 8 weeks, starting from weeks 24 and 26 of pregnancy. Specifically, there will be 2 sessions per week, which the woman can choose, to allow more flexibility toward her needs. RESULTS: The psychoeducational pathway is expected to lead to significant results in terms of usability and engagement in women's interactions with Maia. Furthermore, it is anticipated that there will be improvements in psychological well-being and overall quality of life. The analysis of the data collected in this study will be mainly descriptive, orientated toward assessing the achievement of the study objectives. CONCLUSIONS: Literature has shown that women preferred web-based support during the perinatal period, suggesting that implementing digital interventions can overcome barriers to social stigma and asking for help. Maia can be a valuable resource for regular psychoeducational support for women during pregnancy. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/53890.

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

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

Artificial intelligence of imaging and clinical neurological data for predictive, preventive and personalized (P3) medicine for Parkinson Disease: The NeuroArtP3 protocol for a multi-center research study.

BACKGROUND: The burden of Parkinson Disease (PD) represents a key public health issue and it is essential to develop innovative and cost-effective approaches to promote sustainable diagnostic and therapeutic interventions. In this perspective the adoption of a P3 (predictive, preventive and personalized) medicine approach seems to be pivotal. The NeuroArtP3 (NET-2018-12366666) is a four-year multi-site project co-funded by the Italian Ministry of Health, bringing together clinical and computational centers operating in the field of neurology, including PD. OBJECTIVE: The core objectives of the project are: i) to harmonize the collection of data across the participating centers, ii) to structure standardized disease-specific datasets and iii) to advance knowledge on disease's trajectories through machine learning analysis. METHODS: The 4-years study combines two consecutive research components: i) a multi-center retrospective observational phase; ii) a multi-center prospective observational phase. The retrospective phase aims at collecting data of the patients admitted at the participating clinical centers. Whereas the prospective phase aims at collecting the same variables of the retrospective study in newly diagnosed patients who will be enrolled at the same centers. RESULTS: The participating clinical centers are the Provincial Health Services (APSS) of Trento (Italy) as the center responsible for the PD study and the IRCCS San Martino Hospital of Genoa (Italy) as the promoter center of the NeuroartP3 project. The computational centers responsible for data analysis are the Bruno Kessler Foundation of Trento (Italy) with TrentinoSalute4.0 -Competence Center for Digital Health of the Province of Trento (Italy) and the LISCOMPlab University of Genoa (Italy). CONCLUSIONS: The work behind this observational study protocol shows how it is possible and viable to systematize data collection procedures in order to feed research and to advance the implementation of a P3 approach into the clinical practice through the use of AI models.

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.

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

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

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

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

Customized virtual reality naturalistic scenarios promoting engagement and relaxation in patients with cognitive impairment: a proof-of-concept mixed-methods study.

Being immersed in a natural context has a beneficial and pervasive impact on well-being. Virtual Reality (VR) is a technology that can help expose people to naturalistic scenarios virtually, overcoming obstacles that prevent them from visiting real natural environments. VR could also increase engagement and relaxation in older adults with and without cognitive impairment. The main aim of this study is to investigate the feasibility of a customized naturalistic VR scenario by assessing motion-sickness effects, engagement, pleasantness, and emotions felt. Twenty-three individuals with a diagnosis of cognitive impairment living in a long-term care home participated in our study. At the end of the entire VR experimental procedure with older adults, five health staff operators took part in a dedicated assessment phase focused on evaluating the VR procedure's usability from their individual perspectives. The tools administered were based on self-reported and observational tools used to obtain information from users and health care staff professionals. Feasibility and acceptance proved to be satisfactory, considering that the VR experience was well-tolerated and no adverse side effects were reported. One of the major advantages emerged was the opportunity to deploy customized environments that users are not able to experience in a real context.Trial Registration: National Institute of Health (NIH) U.S. National Library of Medicine, ClinicalTrials.gov NCT05863065 (17/05/2023).

A Nurse-Led Model of Care with Telemonitoring to Manage Patients with Heart Failure in Primary Health Care: A Mixed-Method Feasibility Study.

Purpose: To determine whether a nurse-led care model with telemonitoring in primary care for patients with stable heart failure and their caregivers is feasible and acceptable. Patients and Methods: A mixed-methods feasibility study was conducted. Patients with stable heart failure and their caregivers were consecutively enrolled from March 2021 to April 2022. Participants were managed by nurses in a community health center through education and monitoring with a mobile app. The outcomes were feasibility outcomes, self-care outcomes, and qualitative acceptability and satisfaction. Quantitative and qualitative outcomes were linked to understanding how the model of care might benefit patients. Results: Twenty-six patients and nine of their caregivers were enrolled. Ten participants used the mobile app. Nineteen patients and eight caregivers were interviewed. Participants who improved their self-care appreciated the help in finding coping strategies, being close to the clinic, and feeling cared for. Participants with fewer improvements in self-care perceived the model of care as useless and were far from the centre. Participants decided to use the app mainly for usefulness prevision, and most of them were satisfied. Conclusion: The model of care was not successful in recruiting patients, and adjustments are needed to improve the recruitment strategy and to engage people who perceive the model of care as not useful or unable to use the app.

Organisational models supported by technology for the management of diabetic disease and its complications in a diabetic clinic setting: study protocol for a randomised controlled trial targeting type 2 diabetes individuals with non-ideal glycaemic values (Telemechron study).

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a non-communicable disease representing one of the most serious public health challenges of the twenty-first century. Its incidence continues to rise in both developed and developing countries, causing the death of 1.5 million people every year. The use of technology (e.g. smartphone application-App) in the health field has progressively increased as it has been proved to be effective in helping individuals manage their long-term diseases. Therefore, it has the potential to reduce the use of health service and its related costs. The objective of this study is to evaluate the impact of using a digital platform called "TreC Diabete" embedded into a novel organisational asset targeting poorly controlled T2DM individuals in the Autonomous Province of Trento (PAT), Italy. METHODS: This trial was designed as a multi-centre, open-label, randomised, superiority study with two parallel groups and a 1:1 allocation ratio. Individuals regularly attending outpatient diabetes clinics, providing informed consent, are randomised to be prescribed TreC Diabete platform as part of their personalised care plan. Healthcare staff members will remotely assess the data shared by the participants through the App by using a dedicated online medical dashboard. The primary end-point is the evaluation of the Hb1Ac level at 12-month post-randomisation. Data will be analysed on an intention-to-treat (ITT) basis. DISCUSSION: This trial is the first conducted in the PAT area for the use of an App specifically designed for individuals with poorly controlled T2DM. If the effects of introducing this specific App within a new organisational asset are positive, the digital platform will represent a possible way for people diagnosed with T2DM to better manage their health in the future. Results will be disseminated through conferences and peer-reviewed journals once the study is completed. TRIAL REGISTRATION: ClinicalTrials.gov NCT05629221. Registered on November 29, 2022, prior start of inclusion.

Digital Technologies and the Role of Health Care Professionals: Scoping Review Exploring Nurses' Skills in the Digital Era and in the Light of the COVID-19 Pandemic.

BACKGROUND: The nursing role significantly changed following reforms in the nurse training process. Nowadays, nurses are increasingly trained to promote and improve the quality of clinical practice and to provide support in the assistance of patients and communities. Opportunities and threats are emerging as a consequence of the introduction of new disruptive technologies in public health, which requires the health care staff to develop new digital skills. OBJECTIVE: The aim of this paper is to review and define the role of nurses and the skills they are asked to master in terms of new methodological approaches and digital knowledge in a continuously evolving health care scenario that relies increasingly more on technology and digital solutions. METHODS: This scoping review was conducted using a thematic summary of previous studies. Authors collected publications through a cross-database search (PubMed, Web of Science, Google Scholar) related to new telemedicine approaches impacting the nurses' role, considering the time span of 2011-2021 and therefore including experiences and publications related to the first phase of the COVID-19 pandemic. RESULTS: The assessment was completed between April and July 2021. After a cross-database search, authors reviewed a selection of 60 studies. The results obtained were organized into 5 emerging macro areas: (1) leadership (nurses are expected to show leadership capabilities when introducing new technologies in health care practices, considering their pivotal role in coordinating various professional figures and the patient), (2) soft skills (new communication skills, adaptiveness, and problem solving are needed to adapt the interaction to the level of digital skills and digital knowledge of the patient), (3) training (specific subjects need to be added to nursing training to boost the adoption of new communication and technological skills, enabling health care professionals to largely and effectively use new digital tools), (4) remote management of COVID-19 or chronic patients during the pandemic (a role that has proved to be fundamental is the community and family nurse and health care systems are adopting novel assistance models to support patients at home and to enable decentralization of services from hospitals to the territory), and (5) management of interpersonal relationships with patients through telemedicine (a person-centered approach with an open and sensitive attitude seems to be even more important in the framework of telemedicine where a face-to-face session is not possible and therefore nonverbal indicators are more problematic to be noticed). CONCLUSIONS: Further advancing nurses' readiness in adopting telemedicine requires an integrated approach, including combination of technical knowledge, management abilities, soft skills, and communication skills. This scoping review provides a wide-ranging and general-albeit valuable-starting point to identify these core competences and better understand their implications in terms of present and future health care professionals' roles.

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

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

[The TeMP_cardio Model for the district management of heart failure patients: a feasibility study for the implementation of the family nurse]. / Il modello TeMP_Cardio per la gestione del paziente con scompenso cardiaco sul territorio: uno studio di fattibilità con l'introduzione dell'infermiere di famiglia e comunità.

. The TeMP_cardio Model for the district management of heart failure patients: a feasibility study for the implementation of the family nurse. INTRODUCTION: The need to enhance primary health nursing care and chronic disease management requires the development of complex and feasible models in local contexts. AIM: To test the feasibility of a complex care model, based on the introduction of the family and community nurse for patients with stable heart failure and their caregivers. METHODS: A pre-post six-month feasibility study was conducted in 2021-2022 in the Autonomous Province of Trento. Patients with stable heart failure able to access services were taken in charge with a multidisciplinary model, with the nurse as care manager, and technological and telemonitoring support. RESULTS: 26 patients out of 137 were included and nine of their caregivers. Ten participants accepted to use the mobile app. Twenty-three patients and seven caregivers completed the study, and the app was used regularly by five participants. Self-care skills improved in patients, mostly in self-monitoring, less in caregivers. One access to the emergency department for heart failure exacerbation was detected. CONCLUSIONS: The model was evaluated feasible to retain patients, with the need to build effective strategies for the recruitment, and the regular use of telemonitoring tools.

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

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

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

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

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.

Process evaluation of a bio-behavioural HIV research combined with prevention among GBMSM in 13 European countries.

Comparative European data using Second Generation Surveillance System (SGSS) are scarce among gay, bisexual and other men who have sex with men. This study evaluated the implementation of Sialon II, a bio-behavioural HIV research combined with targeted HIV prevention in 13 European cities conducted in collaboration with community partners. A mixed-methods process evaluation assessed the project's coverage, outputs, quality, challenges and opportunities for improvement. Data collected through structured questionnaire from 71 data collectors from community-based organisations and semi-structured interviews with 17 managers of participating gay venues were analysed. Overall implementation was successful, achieving 4901 valid behavioural questionnaires and obtaining 4716 biological samples. Challenges in conducting bio-behavioural research in gay venues related to strict research protocols and unfavourable characteristics of venues. Formative research, collaboration with community gay venues, and offering HIV prevention emerged as facilitators. Community researchers' training was crucial for fidelity to research protocols, increased trust amongst communities and enabled data collectors to effectively address practical problems in the field. Scientifically sound SGSS with community participation is feasible and allows for including 'hard-to-reach' populations. Prevention benefits include awareness raising, capacity building and sexual health promotion in gay venues. The findings are beneficial for epidemiological research among other HIV key populations.

Implementation of tele visit healthcare services triggered by the COVID-19 emergency: the Trentino Province experience.

AIM: In response to the SARS-CoV-2 emergency, the Competence Centre on digital health 'TrentinoSalute4.0' has developed TreC_Televisita, a tele visit solution that meets the needs of the Trentino healthcare system and maintains high-quality patient-doctor interactions while respecting social distancing. This paper highlights how 'TreC_Televisita' was integrated into the Trentino healthcare system and its potential to become a structural and durable solution for the future local healthcare service provisioning. SUBJECT AND METHODS: This paper presents the multifactorial context that TreC_Televisita has faced for its implementation and the strategies adopted for its structural integration into the healthcare system. The analysis focuses on the main issues faced for the integration of the tele visits (e.g. privacy, payments) and how the context of TrentinoSalute4.0 permitted responding quickly to its implementation during the pandemic. It also describes how TreC_Televisita fits into the healthcare continuum from the organisational and technological standpoint, the end-user perspective and the barriers that could hamper the solution scalability. RESULTS: TreC_Televisita has demonstrated to be a technological solution that can be contextualised for different clinical domains beyond SARS-CoV-2. Moreover, it has shown its potential to scale up the solution beyond the COVID-19 emergency to the whole healthcare provisioning system in the long term. CONCLUSION: Being a positive experience in the first months of its implementation, the long-term goal is to transform TreC_Televisita into a structural pillar of the Trentino healthcare system, setting the bases for a sustainable, win-win situation for all the stakeholders involved in healthcare service provisioning.

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

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