Evaluation of Event-Driven Pre-Exposure Prophylaxis with Tenofovir Alafenamide/Emtricitabine for HIV Prevention in Men Who Have Sex with Men in Thailand and France

The primary objective of this study is to evaluate the **efficacy**, acceptability, and safety of event-driven pre-exposure prophylaxis (PrEP) using TAF/FTC for the prevention of **HIV** in men who have sex with men in Thailand and France. This is clinically relevant as it aims to provide insights into a potentially effective strategy for reducing the incidence of HIV in high-risk populations, thereby contributing to public health efforts in HIV prevention.

The clinical trial for **HIV prevention** involves a total of 314 participants. The study population consists exclusively of male subjects, with an age range that includes both adults and adolescents. Participants were selected based on specific criteria, although the principal inclusion criteria were not provided. The trial does not involve a vulnerable population. Lifestyle considerations such as diet, physical activity, or habits were not specified. The general health status of the participants was not detailed, and the sponsor did not provide information on any additional selection criteria.

The clinical trial is designed as a **randomized controlled trial** to assess the efficacy, acceptability, and safety of event-driven pre-exposure prophylaxis for **HIV prevention** using TAF/FTC in men who have sex with men. The study will be conducted in Thailand and France, with an estimated recruitment start date of March 1, 2023, and an anticipated end date of June 30, 2028. The trial will follow a structured methodology, ensuring rigorous evaluation of the intervention's impact on the target population.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as a screening to determine eligibility based on predefined criteria. Following successful inclusion, participants will be randomly assigned to either the intervention or control group. The trial will employ a double-blind design, ensuring that neither the participants nor the researchers know which group the participants are in, thus minimizing bias. Throughout the study, follow-up visits will be scheduled at regular intervals to monitor participants' health, adherence to the intervention, and any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the trial.

The expected length of participant involvement in the study is approximately five years, aligning with the overall trial duration. However, certain conditions may lead to early termination from the study, such as the occurrence of significant adverse events, non-compliance with study protocols, or withdrawal of consent by the participant. The trial will conclude with an end-of-study visit, where final assessments will be conducted to evaluate the long-term effects of the intervention and gather comprehensive data for analysis.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a paediatric formulation or if it has orphan drug status. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available in the provided data.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized under phase 5, indicating a focus on post-marketing surveillance to gather additional information on the drug's effectiveness and safety in a larger population. The estimated recruitment start date is March 1, 2023, with an anticipated end date of June 30, 2028. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely involve systematic data collection and analysis to evaluate the treatment's impact on the targeted medical condition. The trial's methodology will adhere to rigorous standards to ensure the reliability and validity of the efficacy assessments.