Marsala

This research aims to evaluate the use of HIV pre-exposure prophylaxis (PrEP) in Italy by establishing a large prospective cohort of HIV-negative adults who are sexually active and eligible for PrEP. The study focuses on assessing PrEP's effectiveness, tolerability, adherence, and barriers to long-term use in a real-world setting. It also monitors the incidence of new HIV infections and other sexually transmitted infections (STIs), along with psychological, behavioral, and treatment factors related to PrEP use. Participants include about 5,000 adults aged 18 years or older who are either starting or already using PrEP according to national and international guidelines. The study is conducted across 49 university and hospital infectious disease clinics and 4 community-based checkpoints throughout Italy. Participants attend routine clinical visits every 3 to 5 months, where they undergo HIV and STI testing, safety laboratory tests, and complete electronic questionnaires through a dedicated mobile app. The study will continue for at least 10 years and is coordinated by the National Institute for Infectious Diseases "L. Spallanzani" IRCCS in Rome. During the study, researchers collect sociodemographic, clinical, laboratory, behavioral, and quality-of-life data in a secure electronic case report form managed by the ICONA Foundation. The main outcome measured is the incidence of HIV seroconversion from enrollment onward. Secondary outcomes include monitoring STIs, evaluating PrEP safety and tolerability, and analyzing adherence, persistence in care, and related behavioral factors. Ethics committees at all participating centers have approved the study, ensuring participant safety and confidentiality throughout the long-term follow-up.