MedTrace Logo

Prevention ICONA Dedicated Ensemble

NCT07186244 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • PrEP
  • PrEP Adherence Monitoring
  • HIV
  • HIV -1 Infection
  • STI
  • STI Prevention

Sponsors & Collaborators

  • Fondazione ICONA

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2033-12-31
Completion
2033-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07186244 on ClinicalTrials.gov