Observational Study of HIV Prevention Using Pre-Exposure Prophylaxis PrEP in Italy Tracking Effectiveness, Safety, and Use in Adults

What this Trial Is About

Researchers are evaluating the use of HIV pre-exposure prophylaxis PrEP in Italy to prevent new HIV infections. The study aims to understand how effective and tolerable PrEP is, how well people stick with it, and what barriers exist to its long-term use. It is an observational study coordinated by Fondazione ICONA, including about 5,000 HIV-negative adults who are either starting or continuing PrEP. Participants are followed in 49 hospital and university infectious disease clinics and 4 community-based checkpoints across Italy. They attend routine clinical visits every 3 to 5 months, where they undergo HIV and STI testing, safety laboratory tests, and complete electronic questionnaires via a mobile app. The study collects data on demographics, clinical status, behavior, and quality of life to monitor HIV seroconversion rates and other outcomes. During the study, participants will be monitored for new HIV infections, side effects related to PrEP, adherence to treatment, and behavioral factors affecting persistence in care. Data are securely collected and managed in an electronic case report form. The study will run for at least 10 years, with regular follow-up visits to ensure ongoing assessment of PrEPs real-world use and impact.

Prevention ICONA Dedicated Ensemble