Clinical trials

The main objective of this national study is to evaluate the virological success of long-acting antiretroviral therapy combining cabotegravir and lenacapavir. The study involves patients who have been receiving this treatment for one year or those for whom the physician decides to initiate it. It also aims to evaluate the tolerability of the treatment and changes in the participants' immunovirological profile during follow-up.

In France, French citizens with an annual income less than 10339 euros are considered living with low-income and are eligible to benefit from a public universal healthcare insurance coverage called C2S (complémentaire santé solidaire). C2S covers primary care and hospital care. Non-citizens with low income, like some migrants, can also benefit from a public healthcare insurance coverage called AME ("Aide Medicale d'Etat" for State Medical Aid). These criteria are used as a marker of precarity settings (i.e., socio-economic vulnerability) in France. In France, HIV-related care and treatments are reimbursed at 100% (ALD30), whatever the level of precariousness. ART adherence has been shown significantly lower in PLWH with C2S health insurance coverage. Although BIC/FTC/TAF is a recommended preferred option in naive PLWH and in switch or maintenance therapy in most settings, due to the forgiveness profile and the high genetic barrier to resistance, boosted darunavir (DRV/r) remains even more widely used than 2nd generation InSTIs in populations in precarity settings, and Real World Effectiveness (RWE) with BIC/FTC/TAF is missing to better support its use in these settings. Paris Bichat Hospital (located in one of the poorest districts in the Ile-de-France region) and Nantes university hospital (West France region) follow a cohort of PLWH with a high proportion of populations in precarity settings (i.e with C2S and AME health insurance coverage): Paris Bichat hospital: N=5143 PLWH (December 2021), sex ratio F/M 37/56%, Transgender Women 7%, and born in sub-Saharan African countries 49%. Nantes university hospital: N=2227 PLWH (December 2021), sex ratio F/M 35/65% and born in sub-Saharan African countries 33%. In this cohort of 7370 PLWH in both sites 50% are receiving an InSTI-based ART regimen, regardless of prior treatment history, and at least 40% are receiving care through the C2S or AME, respectively.

The study is a prospective cervical cancer screening intervention in the nonclinical setting of a mobile testing unit in a vehicle, using point-of-care HPV PCR tests with self-collected vaginal swabs. It is designed for women with limited access to healthcare and prevention in underprivileged municipalities in the greater Paris area (Seine-Saint-Denis department, detailed in Annexe 3). HPV positive participants will receive counseiling and guidance to help them find a healthcare professional to take care of their needs

The Delta hepatitis virus (HDV) is a satellite virus that requires the presence of hepatitis B virus (HBV) for infection. Approximately 5% of HBV-infected individuals, or about 12 million people globally, are also carriers of HDV. This dual infection significantly heightens the risk of liver damage and the progression to hepatocellular carcinoma (HCC). Historically, the diagnosis of HDV has been limited, leading to an underestimation of its true prevalence both nationally and internationally. Recent advancements in treatments for viral hepatitis and the introduction of new HDV-specific therapies have spurred increased interest in the virus, prompting public health authorities to call for improved diagnostic and monitoring tools. Detection of HDV typically involves serological tests (ELISA/CLIA) on serum or plasma, followed by viral load quantification using RT-qPCR if positive. However, laboratory access is often insufficient in many regions, particularly affecting marginalized populations and high-endemic areas, especially in low-resource countries. New sample collection methods that help connect patients to expert laboratories are needed, as shipping frozen biological samples can be complex and costly. In response, Dried Blood Spot (DBS) sampling-where serum, plasma, or whole blood is dried on filter paper-has been adopted by numerous public health organizations as a simple, cost-effective, and non-infectious means of storage and transport. DBS is already validated for diagnosing and monitoring infections such as HIV, HBV, and HCV. Given the unique biology of each virus, specific studies are required to determine how using DBS affects detection and quantification thresholds for each laboratory technique. The National Reference Center for Delta Hepatitis (CNR-Delta), commissioned by Public Health France, has developed a DBS protocol for HDV, based on available literature and prior studies regarding storage conditions and reconstitution solutions. Two retrospective studies utilizing CNR collections have established new positivity thresholds for serology and detection/quantification in molecular biology for serum/plasma and EDTA whole blood on DBS. To finalize this protocol, further study of thresholds for capillary blood tests on DBS is essential. Capillary blood, obtained via finger prick, could simplify the use of this tool, reducing the need for specialised equipment and expertise, and potentially allowing for self-sampling by patients. The current study aims to validate the DBS tool for HDV serological and molecular testing using capillary blood. The hypothesis posits that geographical barriers to accessing hospitals and laboratories for HDV patients complicate the shipping of frozen plasma samples, increasing costs. Developing a serological screening and viral load testing technique from a drop of capillary blood on DBS paper could effectively link patients to specialized centers. Since DBS is considered non-infectious, it also mitigates administrative complications. By comparing results from paired samples-plasma (the gold standard) from EDTA whole blood and capillary blood on DBS-we aim to redefine detection and quantification thresholds for both methods. Validating these new thresholds will allow the use of this tool while maintaining quality standards for diagnosing and monitoring active HDV infections.