Clinical Research Directory

Juntas Adelante: A Peer-Coaching Intervention to Promote Chemoprophylaxis for HIV Prevention Among Latina Transgender Women in the Washington DC Metropolitan Area.

The goal of this clinical trial is to evaluate the impact of the Juntas Adelante intervention on awareness and use of chemoprophylaxis for HIV prevention (Pre- and Post-Exposure prophylaxis, or PrEP and PEP) among Latina Transgender Women in the Washington DC Metropolitan Area. Secondary outcomes included awareness and use of Doxy-PEP (i.e., Doxycycline for prevention of Sexually Transmitted Infections - STI), and awareness of Undetectable = Untransmittable (U=U). The main questions are: 1. Is the Juntas Adelante intervention acceptable and feasible to implement with this population? 2. Is participating in the Juntas Adelante intervention associated with increased awareness and use of PrEP and PEP? All participants in the study will view 5 online short videos on HIV and STI prevention and will receive up to two virtual coaching sessions with a peer coach. They will also complete a brief survey after viewing each video (5 total) and three longer surveys/interviews over the course of 3 months.

Prevention ICONA Dedicated Ensemble

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.