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.

Skin cancer risk assessment in dark skinned immigrants: the role of social determinants and ethnicity.

OBJECTIVES: Dark-skinned people have a lower incidence rate of skin cancer, in particular melanoma, which is detected at more advanced stages leading to poorer prognoses and long-term outcomes compared to whites. The gap in survival is due to some difficulty in melanoma detection, lack of attention from doctors and awareness by patients. This study aims to assess skin cancer risk awareness in dark-skinned immigrants and to determine the influence of socioeconomic factors and ethnic origin on behaviors. DESIGN: This is a cross-sectional health facility based study carried out in a 12-month period. A semi-structured questionnaire to assess skin cancer risk awareness and a dermatological examination was offered to dark-skinned immigrants consecutively attending the dermatology department of the National Institute for Health, Migration and Poverty in Rome. RESULTS: 147 dark-skinned immigrants were enrolled, of which 54.4% were males, coming from Africa (53.1%). They were mainly young, aged 18-34 (56.5%). The level of education and length of stay in Italy was significantly related to the awareness about skin cancer: people with a high educational level (OR: 8.1 95% CI: 3.2-23.4) or immigrated more than 4 years before the interview (OR: 2.1 95% CI: 1.0-4.4) have a greater knowledge about skin cancer. CONCLUSIONS: Education level is the strongest predictive factor of skin cancer awareness, whereas cultural behaviours and personal experience of sunburns are the main factors determining sunlight avoidance. Health promotion programs targeting immigrants must consider cultural differences related to ethnicity and country of origin, and adopt a transcultural approach.

The diagnostic challenge of mapping elephantiasis in the Tigray region of northern Ethiopia.

BACKGROUND: In Ethiopia, lymphatic filariasis and podoconiosis are the two neglected tropical diseases planned to be mapped together within the recently launched Ethiopian neglected tropical diseases master plan (2013-2015). However, other disorders cause tropical lymphedema, and this report aims to identify clinical epidemiological aspects of limb swelling in northern Ethiopia and to provide an algorithm orienting the clinical diagnosis. METHODS: Medical records of patients with lower limb elephantiasis attending the Italian Dermatological Centre of Mekele, Tigray capital city, over a 4-year period (2005-2009) were retrospectively analyzed. Nine variables were collected from the charts comprising demographic data, job, origin, literacy, clinical, histopathologic, microscopic, and cultural findings. RESULTS: Over a total of 511 patients, lymphedema resulted from trauma (40.7%), chronic venous insufficiency (12.5%), deep mycoses (10.8%), lymphatic filariasis (9.2%), elephantiasis nostras verrucosa (7.0%), tropical ulcer (6.3%), leprosy (4.9%), recurrent infections (3.1%), podoconiosis (1.8%), tuberculosis (1.0%), malignancy (1.3%), Kaposi's sarcoma (1.0%), leishmaniasis (0.2%), and neurofibromatosis (0.2%). CONCLUSIONS: Advanced-stage elephantiasis, chronic osteomyelitis, and podoconiosis not previously reported in Tigray were observed. Further epidemiological investigation and training programs addressed to healthcare providers at the peripheral level are needed to detect elephantiasis early, prevent disabilities, and improve patients' quality of life.

Operational research on the correlation between skin diseases and HIV infection in Tigray region, Ethiopia.

BACKGROUND: In Ethiopia, skin diseases are among the leading causes of outpatient attendance to primary health service. Correlation of skin diseases and HIV has long been recognized and used to guide medical management in resource-limited settings. Therefore, this study aims to assess the correlation of skin diseases and HIV infection, to estimate epidemiological distribution in the study area, and to provide health workers of skin indicators for HIV early detection. METHODS: The operational research was designed as a case-control study and carried out in three intervention districts of Tigray region; baseline and final data on skin diseases and HIV were compared with those of three control districts matched for population size, density, and environmental characteristics. Health workers of intervention districts were trained on skin diseases/STIs diagnosis and treatment. Data were collected from study and control districts and then analyzed at the Italian Dermatological Centre (IDC) in Mekele. RESULTS: In the research period, a total of 1044 HIV positive patients were detected. Disorders of skin and mucous membranes statistically related with HIV (P < 0.05) were tongue papillary atrophy (80%), oral hairy leukoplakia (69%), herpes zoster (66%), oral candidiasis (50%), pruritic papular eruption (43%), condylomata acuminata (38%), and telogen effluvium (27%). CONCLUSIONS: The high frequency of oral disorders and telogen effluvium is not described in literature and may be indicative for case detection. Operational research offers significant gains on health service delivery and outcomes at relatively low cost and in a short timeframe.

Clinical-epidemiological features of contact dermatitis in rural and urban communities in northern Ethiopia: correlation with environmental or occupational exposure.

BACKGROUND: The widespread diffusion of low-quality products as well as the local cultural habits could be a relevant cause of allergic diseases in developing countries. In the present observational study, we explored the prevalence of allergic contact dermatitis in both rural and urban settings in northern Ethiopia, where skin diseases represent a frequent cause of morbidity. Clinical features and specific reactivities in association with environmental or occupational exposure were investigated. PATIENTS AND METHODS: We patch tested 480 consecutive patients, visited at the Mekele IDC, exhibiting symptoms of contact dermatitis. A detailed medical history of each patient was collected. RESULTS: A positive patch-test response was observed in 50% of subjects; nickel was the most frequent sensitizer (26.2%), followed by p-tert-butylphenol formaldehyde resin (10%), fragrance mix (7.1%), potassium dichromate (5.4%), cobalt chloride (4.6%), disperse blue (2.3%), and p-phenylenediamine (1.7%). Gender-related differences were analyzed for single allergen. Eczema represented the most common manifestation, affecting the head and neck as primary skin areas. While reactivity to nickel interested almost all the occupational categories, sensitization to other allergens could be ascribed to working habits or environmental exposure. CONCLUSIONS: The results gathered from this study, the first one conducted within the Tigray region in Ethiopia, confirm the need to take appropriate measures to limit the nickel rate in metal objects and may be useful to design allergenic series suitable for patch testing in those geographical settings.