Clinical Research Directory

Study on Retention in Care and on Clinical Chracteristics of HIV-infected Women Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIKWO).

Women are an underrepresented population in clinical studies on HIV and antiretroviral therapy. This study aims to help bridge this gap by providing real-world data on therapeutic management with B/F/TAF (Biktarvy) in an exclusively female cohort, aiming to improve treatment personalization and the early identification of risk factors for poor retention and treatment failure in this population. This study is single-center, ambispective observational. The retrospective component analyzes medical record data from June 2019 (the date BIC/FTC/TAF became available in Italy) to the study data cutoff. The prospective component involves data collection during routine follow-up visits up to December 31, 2027. No diagnostic or therapeutic procedures beyond standard clinical practice are involved. The study opulation includes adult women (≥18 years of age) with a confirmed diagnosis of HIV-1 infection who have received at least one prescription for BIC/FTC/TAF at the Infectious Diseases Unit of E.O. Ospedali Galliera in Genoa from June 2019 to the present, with a documented follow-up of at least 6 months. The primary objective of the study is to determine the 12- and 24-month retention-in-care rates among women treated with B/F/TAF (Biktarvy) and to identify factors associated with treatment maintenance and predictors of treatment discontinuation. Secondary objectives of the study include: * Percentage of women achieving/maintaining virologic suppression (\<50 copies/mL) at 12 and 24 months during B/F/TAF treatment * Evaluation of treatment persistence with B/F/TAF across different age groups * Analysis of reasons for discontinuing B/F/TAF (adverse events, patient choice, planned switch, other) * Identification of factors associated with virologic failure during B/F/TAF therapy * Evaluation of the impact of menopausal status (pre- vs. post-menopause) on retention and virologic outcomes * Analysis of the effect of the menopausal transition during follow-up on outcomes * Correlation of past virologic history (nadir CD4, peak viremia, previous failures) with outcomes * Evaluation of the impact of prior antiretroviral treatment history (previous lines, drug classes used, documented resistance) * Analysis of demographic and socioeconomic variables associated with treatment persistence and virologic success

A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test

The objectives of this study are as follows: To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings To evaluate the usability of the TruPlex test through: Structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings. To assess user interpretation accuracy through a contrived result interpretation questionnaire, where intended users evaluate a set of pre-defined test results (e.g., strong/weak positives, negatives, invalids). To monitor test system reliability, including invalid rates.

REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE

Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment. These pauses in medication can happen for many reasons, such as side effects, challenges with getting to the clinic, personal circumstances, stigma, or difficulties with everyday life. When HIV treatment is stopped, the viral load can increase, which may affect a person's health and make it easier for HIV to be passed on to others. Restarting treatment quickly after an interruption is important for both personal and public health. However, it can be difficult for people who miss doses to get back on treatment right away. There are often several steps and medical appointments required before restarting, such as waiting for lab results or reviewing medical history, which can cause further delays. These additional steps can make it even harder for people to re-engage and may discourage them from returning to care. The REINITIATE study is designed for people living with HIV who have not taken any antiretroviral medications for at least the last 12 weeks. The study will offer participants a way to restart their HIV therapy quickly, by beginning treatment with B/F/TAF on the same day that they return to care. B/F/TAF is a widely used, once-daily HIV regimen, and is recommended in national treatment guidelines. Researchers want to find out if this rapid restart approach is safe and effective, and whether it helps people regain control of HIV and remain in care. The study will also examine how many participants are able to keep the virus at a low level (viral suppression), stay engaged in their HIV care, and tolerate the medication after rapidly restarting treatment. In addition, the study will include interviews with some participants, to gain a better understanding of why they stopped taking their medications and what supported their return to treatment. These insights could help healthcare teams develop better ways to support people living with HIV in the future.