Prevention ICONA Dedicated Ensemble
PrIDE
Implementation of an Italian Cohort of People on HIV-1 Pre-exposure Prophylaxis Within the ICONA Network: PrIDE (Prevention ICONA Dedicated Ensemble)
1 other identifier
observational
5,000
1 country
53
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Longer than P75 for all trials
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2024
CompletedFirst Submitted
Initial submission to the registry
August 4, 2025
CompletedFirst Posted
Study publicly available on registry
September 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2033
September 22, 2025
August 1, 2025
9.3 years
August 4, 2025
September 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of HIV seroconversion in individuals taking PrEP, from the time of cohort enrollment.
HIV seroconversion is defined as a new HIV infection occurring in a participant during the observational follow-up period. Seroconversion will be determined by a reactive 4th-generation HIV antibody/antigen (Ab/Ag) test confirmed by detectable HIV-RNA using real-time PCR. The measure will be taken at routine clinical visits approximately every 3 months, or when clinically indicated, according to national guidelines. All cases of confirmed HIV infection will be reviewed and documented by the coordinating center.
Perioperative/Periprocedural
Secondary Outcomes (3)
Tolerability of PrEP expressed as the number of adverse events per person-years of follow-up after study enrollment
Perioperative/Periprocedural
Assess behavioral-related factors influencing PrEP use and persistence in care through questionnaires
Perioperative/Periprocedural
Assess adherence-related factors influencing PrEP use and persistence in care through questionnaire
Perioperative/Periprocedural
Study Arms (1)
PrIDE Cohort
Eligibility Criteria
Prospective enrollment is planned for all individuals taking PrEP in Italy, with the aim of establishing a cohort under active follow-up. Eligible participants are adults (\>18 years old), HIV-negative, and sexually active, who-according to approved national and international guidelines and/or standard clinical practice-are deemed suitable to receive a PrEP prescription or are already undergoing PrEP.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione ICONAlead
Study Sites (53)
Ospedale Clinicizzato SS. Annunziata - Scuola di Specializzazione di Malattie Infettive
Chieti, Abruzzo, Italy
Ospedale Civile Santo Spirito - U.O. Malattie Infettive
Pescara, Abruzzo, Italy
AOU Consorziale - Policlinico Giovanni XXIII - Struttura Complessa di Malattie Infettive
Bari, Apulia, Italy
A.O.U. Ospedali Riuniti di Foggia - U.O.C. di Malattie Infettive
Foggia, Apulia, Italy
Ospdale San Carlo
Potenza, Basilicate, Italy
Università della Campania Luigi Vanvitelli - Malattie Infettive
Caserta, Campania, Italy
A.O.U. Federico II - U.O.C. di Malattie Infettive
Napoli, Campania, Italy
Azienda Ospedaliera dei Colli - Monaldi Cotugno CTO - IV Divisione, U.O.C. di Immunodeficienze e Malattie Infettive di Genere
Napoli, Campania, Italy
Presidio Ospedaliero A.O.U. Vanvitelli - U.O. di Malattie Infettive
Napoli, Campania, Italy
A.O.U. Policlinico S. Orsola-Malpighi, Università degli Studi di Bologna - U.O. di Malattie Infettive
Bologna, Emilia-Romagna, Italy
BLQ Check Point
Bologna, Emilia-Romagna, Italy
A.O.U. di Ferrara - Arcispedale Sant'Anna - U.S. Gestione Ambulatorio HIV/AIDS U.O. Malattie Infettive
Ferrara, Emilia-Romagna, Italy
Università degli Studi di Modena e Reggio Emilia, Modena - Clinica di Malattie Infettive e Tropicali
Modena, Emilia-Romagna, Italy
Azienda Ospedaliera Arcispedale Santa Maria Nuova - U.O. Malattie Infettive
Reggio Emilia, Emilia-Romagna, Italy
Azienda Ospedaliera Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia - Clinica Malattie Infettive
Udine, Friuli Venezia Giulia, Italy
Università Sapienza Polo Pontino - U.O. di Malattie Infettive
Latina, Lazio, Italy
Circolo Mario Mieli
Rome, Lazio, Italy
INMI "L. Spallanzani" IRCCS - U.O.C. Immunodeficienze Virali
Rome, Lazio, Italy
Roma Check Point
Rome, Lazio, Italy
Università Cattolica del Sacro Cuore - Istituto di Clinica delle Malattie Infettive
Rome, Lazio, Italy
Università degli Studi "La Sapienza" - Dipartimento di Malattie Infettive e Tropicali
Rome, Lazio, Italy
Università degli Studi di Roma, Policlinico "Tor Vergata" - Divisione di Malattie Infettive
Rome, Lazio, Italy
Ospedale Bel Colle Viterbo - U.O.C. Medicina protetta - Malattie infettive
Viterbo, Lazio, Italy
Università di Genova e Ospedale Policlinico San Martino - Clinica di Malattie Infettive
Genoa, Liguria, Italy
ASST Papa Giovanni XXIII , Struttura Complessa Malattie Infettive
Bergamo, Lombardy, Italy
Azienda Ospedaliera Spedali Civili di Brescia - I Divisione di Malattie Infettive
Brescia, Lombardy, Italy
Istituti Ospitalieri di Cremona - U.O. Malattie Infettive
Cremona, Lombardy, Italy
ASST di Lecco - Ospedale Alessandro Manzoni - S.C. di Malattie Infettive
Lecco, Lombardy, Italy
Associazione Milano Check Point
Milan, Lombardy, Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco - Dipartimento Malattie Infettive
Milan, Lombardy, Italy
ASST Grande Ospedale Metropolitano Niguarda - S.C. Malattie Infettive
Milan, Lombardy, Italy
ASST Santi Paolo e Carlo - U.O.C. di Malattie Infettive e Tropicali, Presidio San Paolo
Milan, Lombardy, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Divisione di Malattie Infettive
Milan, Lombardy, Italy
Ospedale San Raffaele, Università Vita-Salute - Clinica Malattie Infettive
Milan, Lombardy, Italy
Ospedale Amedeo di Savoia, Università degli Studi di Torino - Clinica di Malattie Infettive
Turin, Piedmont, Italy
Policlinico Universitario Duilio Casula, AOU di Cagliari - Medicina Interna e Malattie del Fegato
Cagliari, Sardinia, Italy
Azienda Ospedaliero Universitaria di Sassari, Malattie Infettive Dipartimento di Medicina Clinica e Sperimentale
Sassari, Sardinia, Italy
ARNAS Garibaldi - P.O. Nesima - U.O.C. di Malattie Infettive
Catania, Sicily, Italy
PO "Umberto I" ASP
Enna, Sicily, Italy
Ospedale Paolo Borsellino - Unità Operativa Complessa Malattie Infettive - ASP
Marsala, Sicily, Italy
A.O.U. Policlinico "G. Martino" - U.O.C. di Malattie Infettive
Messina, Sicily, Italy
A.O.U. Policlinico "P. Giaccone" - U.O.C. Malattie Infettive e Centro Regionale di Riferimento AIDS
Palermo, Sicily, Italy
ARNAS Civico di Cristina Benfratelli - Unità Operativa Malattie infettive
Palermo, Sicily, Italy
Azienda Sanitaria Provinciale 8 - Presidio Umberto I - U.O. di Malattie Infettive
Syracuse, Sicily, Italy
A.O.U. Ospedali Riuniti Umberto I - Salesi - Lancisi- Università Politecnica delle Marche Servizio Regionale di Immunologia Clinica e Tipizzazione Tessutale
Ancona, The Marches, Italy
Azienda Sanitaria dell'Alto Adige - Malattie Infettive
Bolzano, Trentino-Alto Adige, Italy
Ospedale Santa Chiara di Trento - Unità Operativa di Malattie Infettive
Trento, Trentino-Alto Adige, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi - S.O.D. di Malattie Infettive e Tropicali
Florence, Tuscany, Italy
Ospedale Santa Maria Annunziata - Azienda Sanitaria di Firenze - U.O. di Malattie Infettive
Florence, Tuscany, Italy
Presidio Ospedaliero di Pistoia - U.O. Malattie Infettive II
Pistoia, Tuscany, Italy
A.O.U. Senese, Policlinico S. Maria alle Scotte - U.O.C. di Malattie Infettive
Siena, Tuscany, Italy
Azienda Ospedaliera di Padova - U.O.C. Malattie Infettive
Padua, Veneto, Italy
Azienda ULSS 8 Berica - Divisione Malattie Infettive
Vicenza, Veneto, Italy
Biospecimen
Participants who experience a documented HIV seroconversion (breakthrough infection) during the study or within 12 months after its completion, defined as reactivity to a 4th-generation HIV Ab/Ag test with detectable HIV-RNA on real-time PCR testing, will undergo blood sampling for: * Pharmacological drug level testing in peripheral blood * Lymphocyte typing
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2025
First Posted
September 22, 2025
Study Start
September 9, 2024
Primary Completion (Estimated)
December 31, 2033
Study Completion (Estimated)
December 31, 2033
Last Updated
September 22, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share