COMPARING STIs POCTs WITH LABORATORY TESTS IN A MSM POPULATION ATTENDING A HIV/STIs CLINIC IN THE FRAMEWORK OF THE WHO ProSPeRo INITIATIVE

Despite the concerted efforts in promoting prevention and testing campaigns and the availability of highly effective treatments, HIV and other sexually transmitted infections (STIs) continue to represent a pressing public health issue worldwide. These infections disproportionally affect the so-called vulnerable populations. In Europe, the majority of HIV/STIs new diagnosis are amongst Men who have Sex with Men. Notwithstanding the rapid development of diagnostic technologies for HIV and other STIs, laboratory-based tests are not always suitable for being used both in resource-limited settings, where diagnostic access and delivery are difficult, and in high-income countries to reach the vulnerable groups. To overcome this issue, WHO endorsed the development of STIs Point-Of-Care Tests (POCTs) to tackle HIV/STIs worldwide. So far, little is known either about the STIs POCTs performance in real life setting or about the potential impact of the replacement of standard laboratory methods with the POCTs approach among different high-risk target populations. To collect robust and reliable data on those issues, in 2017 the Reproductive Health and Research (RHR) Department of WHO launched an independent evaluation on the performance of STIs POCTs among target populations called Project on Sexually Transmitted Infections Point-of-care testing established by the Reproductive Health and Research Department of WHO (ProSPeRo initiative). This thesis is to report the methodological structure and the main finding of the two studies carried out at the HIV/STIs clinic of Verona, Italy between 2017 and 2018. Considered that in the European context, and in Italy as well, the most at risk population for HIV, syphilis and gonorrhoeae is that of Men who have Sex with Men, we decided to implement the two clinical-based studies amongst them: the evaluation of the dual HIV/syphilis POCTs and that of the NG/CT POCT in genital and extragenital sites. Between May 2018 and February 2019, 492 individuals were enrolled in the HIV/Syphilis study and 300 in the NG/CT one. In the HIV/Syphilis POCT evaluation, the rapid tests yielded an almost perfect performance as far as the HIV component is concerned. As for the treponemal component, despite specificity was very high, sensitivity was found to range between 75,8 and 81,7%. In the NG/CT POCT study, the performance varied according to the anatomical site and the considered pathogen. Indeed, although specificity was found to be always above 98%, when the NG component of the POCT is taken into account, the sensitivity ranged from 75% at pharyngeal site to 87,5% at rectal and urethral site. As for the CT component of the POCT, sensitivity was 100% with pharyngeal samples and 90%, 83,3% with rectal and urethral samples, respectively. STIs POCTs are valuable tools to tackle HIV/STIs worldwide although their routinary use have to be considered in close relation with the epidemiological characteristics of the population itself, beyond the analytical characteristics of the test. The findings of this thesis support the need for independent evaluation of new diagnostic technology before being integrated in the clinical practice as well as importance of alignment of such an evaluation with the best international standards.