Prevention ICONA Dedicated Ensemble

Recruiting now

Conditions studied: PrEP, PrEP Adherence Monitoring, HIV, HIV -1 Infection, STI, STI Prevention

In brief

Despite significant advances in HIV treatment, transmission remains a public health concern. In 2022, there were 1.3 million new HIV infections worldwide and 1,888 new diagnoses in Italy, with sexual transmission being the predominant route. Many individuals are still diagnosed late, and a portion of people living with HIV are unaware of their status. Pre-Exposure Prophylaxis (PrEP) has emerged as an effective biomedical strategy to prevent new infections, especially when integrated into comprehensive prevention efforts. Study Objectives The primary objective of this observational study is to establish a large prospective cohort of individuals using PrEP in Italy. The study aims to assess PrEP's effectiveness, tolerability, adherence, and barriers to long-term use in a real-world setting. These data will be instrumental in guiding future strategic interventions to optimize PrEP management and move toward the goal of zero new HIV infections in Italy. Primary Objective * To assess the incidence of new HIV infections among PrEP users in Italy. Secondary Objectives * Incidence of other sexually transmitted infections (STIs); * Tolerability of PrEP; * Psychological and behavioral aspects related to PrEP use; * Adherence and persistence in care; * Use of therapies and prophylaxis for STIs during PrEP use. Study Design and Coordination This is a prospective observational study, promoted by Fondazione ICONA in collaboration with clinical centers and community-based organizations. The coordinating enrolling center is INMI "L. Spallanzani" IRCCS in Rome. Participating Centers: * 49 university and hospital-based centers across Italy; * 4 non-clinical checkpoints offering PrEP screening, prescription, and follow-up. Study Population Adults (≥18 years) who are HIV-negative, sexually active, and considered eligible for PrEP per national or international guidelines, including both new and current PrEP users. Inclusion Criteria * Age ≥18 years; * Negative HIV test at enrollment; * Willingness to initiate or continue PrEP; * Informed consent provided. Exclusion Criteria * HIV infection or strong suspicion of infection; * Contraindications to PrEP medications; Known allergy to PrEP components; Refusal to comply with study procedures.

Key facts

Study ID

NCT07186244

Run by

Fondazione ICONA

People needed

5000

Starts

2024-09-09

Expected to finish

2033-12-31

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age >18 years
• Negative HIV Ab/Ag test (4th generation or higher) at the enrollment visit
• Request and/or willingness to take PrEP, or already on PrEP
• Ability to understand the study procedures and to sign informed consent

You may not qualify if…

• Individuals with HIV infection or with strong clinical/epidemiological suspicion of HIV infection
• Individuals with contraindications to the use of medications included in the PrEP regimen (as per the product information)
• Documented allergy to one or more pharmacological components of the proposed PrEP regimen
• Lack of willingness to adhere to the required procedures and follow-up assessments

Where it is running

• Circolo Mario Mieli — Rome, Lazio, Italy (enrolling)
• Ospedale San Raffaele, Università Vita-Salute - Clinica Malattie Infettive — Milan, Lombardy, Italy (enrolling)
• BLQ Check Point — Bologna, Emilia-Romagna, Italy (enrolling)
• PO "Umberto I" ASP — Enna, Sicily, Italy (enrolling)
• Ospedale Amedeo di Savoia, Università degli Studi di Torino - Clinica di Malattie Infettive — Turin, Piedmont, Italy (enrolling)
• Università degli Studi "La Sapienza" - Dipartimento di Malattie Infettive e Tropicali — Rome, Lazio, Italy (enrolling)
• INMI "L. Spallanzani" IRCCS - U.O.C. Immunodeficienze Virali — Rome, Lazio, Italy (enrolling)
• Azienda ULSS 8 Berica - Divisione Malattie Infettive — Vicenza, Veneto, Italy (enrolling)
• Roma Check Point — Rome, Lazio, Italy (enrolling)
• Università degli Studi di Modena e Reggio Emilia, Modena - Clinica di Malattie Infettive e Tropicali — Modena, Emilia-Romagna, Italy (enrolling)
• Azienda Ospedaliero Universitaria di Sassari, Malattie Infettive Dipartimento di Medicina Clinica e Sperimentale — Sassari, Sardinia, Italy (enrolling)
• ASST Papa Giovanni XXIII , Struttura Complessa Malattie Infettive — Bergamo, Lombardy, Italy (enrolling)
• ASST di Lecco - Ospedale Alessandro Manzoni - S.C. di Malattie Infettive — Lecco, Lombardy, Italy (enrolling)
• Associazione Milano Check Point — Milan, Lombardy, Italy (enrolling)
• ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco - Dipartimento Malattie Infettive — Milan, Lombardy, Italy (enrolling)
• ASST Grande Ospedale Metropolitano Niguarda - S.C. Malattie Infettive — Milan, Lombardy, Italy (enrolling)
• ASST Santi Paolo e Carlo - U.O.C. di Malattie Infettive e Tropicali, Presidio San Paolo — Milan, Lombardy, Italy (enrolling)
• Azienda Ospedaliera di Padova - U.O.C. Malattie Infettive — Padova, Veneto, Italy (enrolling)
• Istituti Ospitalieri di Cremona - U.O. Malattie Infettive — Cremona, Lombardy, Italy
• ARNAS Garibaldi - P.O. Nesima - U.O.C. di Malattie Infettive — Catania, Sicily, Italy
• Azienda Ospedaliera Spedali Civili di Brescia - I Divisione di Malattie Infettive — Brescia, Lombardy, Italy
• Università Cattolica del Sacro Cuore - Istituto di Clinica delle Malattie Infettive — Rome, Lazio, Italy
• Policlinico Universitario Duilio Casula, AOU di Cagliari - Medicina Interna e Malattie del Fegato — Cagliari, Sardinia, Italy
• Università di Genova e Ospedale Policlinico San Martino - Clinica di Malattie Infettive — Genoa, Liguria, Italy
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Divisione di Malattie Infettive — Milan, Lombardy, Italy

Full record on ClinicalTrials.gov

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