NCT07186244: PrIDE

Prevention ICONA Dedicated Ensemble

Recruiting now Last updated 22 September 2025

What this trial tests

trial in PrEP in 5,000 participants. Currently enrolling.

Timeline

9 September 2024

Primary endpoint
31 December 2033

31 December 2033

Quick facts

Lead sponsor	Fondazione ICONA
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	5,000
Start date	9 September 2024
Primary completion	31 December 2033
Estimated completion	31 December 2033
Sites	53 locations across Italy

Conditions studied

• PrEP — all drugs for PrEP →
• PrEP Adherence Monitoring — all drugs for PrEP Adherence Monitoring →
• HIV — all drugs for HIV →
• HIV -1 Infection — all drugs for HIV -1 Infection →

Sponsor

Fondazione ICONA

Who can join

18 and older, any sex, with PrEP or PrEP Adherence Monitoring. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Implementation of HIV pre-exposure prophylaxis (PrEP) in Italy (2023-2024): Results from the PrIDE cohort survey.
   Nozza S, Masoero T, Tavelli A, Leserri F, et al · · 2026 · cited 1× · PMID 41846041 · DOI 10.1016/j.ijid.2026.108555