| NCT ID | NCT07186244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione ICONA |
| Condition | PrEP |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2033-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2024-09-09 with a primary completion date of 2033-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07186244 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PrEP. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07186244 currently recruiting?
Yes, NCT07186244 is actively recruiting participants. Contact the research team at thomas.masoero@icona.org for enrollment information.
Where is the NCT07186244 trial being conducted?
This trial is being conducted at Chieti, Italy, Pescara, Italy, Bari, Italy, Foggia, Italy and 11 additional locations.
Who is sponsoring the NCT07186244 clinical trial?
NCT07186244 is sponsored by Fondazione ICONA. The trial plans to enroll 5,000 participants.