ICONA Prevention Program for People Using PrEP in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• BLQ Check Point
  Bologna, Emilia-Romagna, Italy Recruiting
• Università degli Studi di Modena e Reggio Emilia, Modena - Clinica di Malattie Infettive e Tropicali
  Modena, Emilia-Romagna, Italy Recruiting
• Circolo Mario Mieli
  Rome, Lazio, Italy Recruiting
• INMI "L. Spallanzani" IRCCS - U.O.C. Immunodeficienze Virali
  Rome, Lazio, Italy Recruiting
• Roma Check Point
  Rome, Lazio, Italy Recruiting
• Università degli Studi "La Sapienza" - Dipartimento di Malattie Infettive e Tropicali
  Rome, Lazio, Italy Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Thomas Masoero Mr., Master of Science
• Email: thomas.masoero@icona.org
• Phone: +39 3481134565

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Restarting HIV treatment with a single-pill regimen (B/F/TAF) after a treatment gap

  This study tests whether quickly restarting ART with the single-pill regimen B/F/TAF is safe and effective for people with HIV who have had a treatment interruption of at least 12 weeks.

  Recruiting at 10 sites Phase 4 CAN Community Health · Clearwater, Florida and 9 other locations · NCT07476339

• Linking Youth to PrEP Services for HIV Prevention

  This project tests a community-based PrEP delivery plus a supportive mobile app to help teens and young adults steadily use PrEP.

  Recruiting at 4 sites Westat · San Francisco, California and 3 other locations · NCT07438041

• PrEP Optimization Through Enhanced Continuum Tracking (PrOTECT AL)

  This project will test a real-time PrEP care dashboard and implementation strategies at seven Alabama clinics to see if they increase PrEP coverage and equity among people at risk for HIV.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT07231640

• Bringing PrEP to a family planning clinic

  This study tests whether offering PrEP in a family planning clinic is acceptable to patients and feasible for providers in Rhode Island.

  Recruiting Women and Infants Hospital of Rhode Island · Providence, Rhode Island · NCT06930508

• Evaluating a PrEP implementation strategy for incarcerated individuals

  This study is testing a new way to help people in jail get access to PrEP and learn about HIV prevention to see if it can improve their health outcomes.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT06919419

• Predicting STIs in people using HIV prevention medication in Spain

  This study is trying to see if a new way to predict sexually transmitted infections can help people using HIV prevention medication in Spain stay healthier.

  Recruiting at 26 sites Hospital Universitario de Valme · Almería and 25 other locations · NCT06860945

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.