Home › Trials › NCT07186244

ICONA Prevention Program for People Using PrEP in Italy

Implementation of an Italian Cohort of People on HIV-1 Pre-exposure Prophylaxis Within the ICONA Network: PrIDE (Prevention ICONA Dedicated Ensemble)

Fondazione ICONA · NCT07186244

This program will follow HIV-negative adults in Italy who are starting or already using PrEP to see how well PrEP prevents HIV, how tolerable it is, and what helps or hinders people from staying on it.

Quick facts

Study typeObservational
Enrollment5000 (estimated)
Ages18 Years and up
SexAll
SponsorFondazione ICONA (other)
Locations53 sites (Chieti, Abruzzo and 52 other locations)
Trial IDNCT07186244 on ClinicalTrials.gov

What this trial studies

The PrIDE project is a national, multicenter prospective observational cohort enrolling about 5,000 HIV-negative adults who are initiating or already taking PrEP at 49 hospital/university infectious disease clinics and 4 community sites across Italy. Participants are followed every 3–5 months during routine clinical visits with HIV and STI testing, safety laboratory monitoring, and electronic questionnaires completed via a dedicated mobile app; data are captured in a secure, encrypted eCRF managed by the ICONA Foundation. The primary outcome is HIV seroconversion, while secondary outcomes include STI incidence, safety and tolerability, adherence and persistence metrics, and behavioral and quality-of-life measures. The study is coordinated by the National Institute for Infectious Diseases "L. Spallanzani" IRCCS in Rome, will run for at least 10 years, and requires ethics approval at participating centers.

Who should consider this trial

Good fit: HIV-negative adults (age ≥18) in Italy who are willing to start or are already taking PrEP and can provide informed consent are ideal candidates.

Not a fit: People living with HIV, those with contraindications or allergies to PrEP medications, or those unwilling to adhere to follow-up procedures are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the data could improve how PrEP is delivered and supported in Italy, helping more people stay protected and reducing new HIV infections.

How similar studies have performed: Randomized trials and observational programs (for example iPrEx, PROUD, and IPERGAY) have shown strong PrEP effectiveness, and this study extends that evidence into a large national real-world cohort.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Chieti, Abruzzo and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

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

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.