[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":130},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,69,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100623854","cabotegravirlenacapavir-dual-long-acting-therapy-cohort-imea-074-100623854",false,"NCT07402044","CABOTEGRAVIR\u002FLENACAPAVIR DUAL LONG ACTING THERAPY (COHORT IMEA 074)","CAbotégravir LENacapavir DUal Long Acting). Immuno-virological Monitoring and Safety Assessment of HIV-1 Infected Patients Receiving a Long-Acting Antiretroviral Combination of Cabotegravir and Lenacapavir","* Age ≥18 years\n* HIV-1 infection\n* Patients who started taking cabotegravir combined with lenacapavir between July 2024 and the one-year follow-up, or who are due to start taking the CAB\u002FLEN combination.\n* Patients who are due to start the CAB\u002FLEN combination following a medical decision.\n\nExclusion Criteria:\n\n* Participants' objection to the use of follow-up data","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","48 Weeks","OBSERVATIONAL","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.",[25,26],"CABOTEGRAVIR","LENACAPAVIR",[28,29,30,31],"Lenacapavir","Cabotegravir","HIV","Multicentre cohort","NOT_YET_RECRUITING","2026-03-23",{"date":35,"type":36},"2026-03-27","ACTUAL",{"date":38,"type":20},"2026-03-15",{"date":40,"type":20},"2028-03-15",{"name":42,"class":43},"Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba","OTHER",13,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100602365","real-world-effectiveness-of-bictegraviremtricitabinetenofovir-alafenamidebicftctaf-in-plwh-in-precarity-settings-in-france--imea073-100602365","NCT07122557","Real World Effectiveness of Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide(BIC\u002FFTC\u002FTAF) in PLWH in Precarity Settings in France -IMEA073","Real World Effectiveness of Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide(BIC\u002FFTC\u002FTAF) in PLWH in Precarity Settings in France","PRECARITY","Inclusion Criteria:\n\n* HIV-1 infected patients \\> 18 years during the observation period\n* PLWH with C2S or AME heath insurance coverage information available during the observation period\n* Treatment naive (TN) on BIC\u002FFTC\u002FTAF OR Treatment experienced virologically suppressed (VS TE) or virologically unsupressed (VU TE) in 2d line BIC\u002FFTC\u002FTAF\n* Had at least one follow-up visit after baseline\n\nExclusion Criteria:\n\n* Missing information regarding health insurance coverage\n* On regimen other than BIC\u002FFTC\u002FTAF",{"count":54,"type":20},320,"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\u002FFTC\u002FTAF 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\u002Fr) remains even more widely used than 2nd generation InSTIs in populations in precarity settings, and Real World Effectiveness (RWE) with BIC\u002FFTC\u002FTAF is missing to better support its use in these settings.\n\nParis 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\u002FM 37\u002F56%, Transgender Women 7%, and born in sub-Saharan African countries 49%. Nantes university hospital: N=2227 PLWH (December 2021), sex ratio F\u002FM 35\u002F65% 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.",[57,58,59,60],"HIV-1","Public Universal Healthcare Insurance Coverage","BIC\u002FFTC\u002FTAF","Low Income Population","2025-08-07",{"date":63,"type":36},"2025-08-14",{"date":65,"type":20},"2025-09",{"date":67,"type":20},"2025-12",{"name":42,"class":43},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100566548","mobile-outreach-screening-of-high-risk-human-papillomavirus-infection-in-women-with-limited-access-to-health-services-in-seine-saint-denis-greater-paris-area-france-100566548","NCT06656611","Mobile Outreach Screening of High-Risk Human Papillomavirus Infection in Women with Limited Access to Health Services in Seine-Saint-Denis (greater Paris Area, France)","PAPMOBILE: Mobile Outreach Screening of High-Risk Human Papillomavirus Infection in Women with Limited Access to Health Services in Seine-Saint-Denis (greater Paris Area, France)","PAPMOBILE","Inclusion Criteria:\n\n* \\- Women from 30 to 65 years of age presenting to the \" Bus Santé \" nonclinical testing unit, eligible to cervical cancer screening by an HPV-HR test\n* Women affiliated to the French social security or immigrants benefiting from the state medical aid program for undocumented immigrants (Aide Médicale d'Etat). The inclusion of people not affiliated to a social security system is an exception and depends on the decision of the Personal Protection Committee, if it is based on an expected benefit for these people of a nature to justify the foreseeable risk incurred.\n* The intervention is designed for vulnerable women with limited access to healthcare, including but not limited to:\n\n  * Women living in shelters and hostels, women living in the streets, in squats, hot-bedding arrangements, emergency social housing;\n  * Recent immigrants, documented or undocumented;\n  * Young adults from priority neighbourhoods,\n  * Isolated or marginalized women\n* Free, informed, written consent, signed by the person and the investigator at the latest on the day of inclusion and before any sampling carried out as part of the trial (article L1122-1-1 of the Public Health Code)\n\nThe Bus will operate in underprivileged neighbourhoods in the greater Paris area (eastern Seine-Saint-Denis department.\n\nExclusion Criteria:\n\n* Screened for cervical cancer by a PAP smear in the last 3 years or by an HPV test in the last 5 years,\n* Women on their period (haemoglobin inhibits PCRs)\n* Pregnancy in the 2nd and 3rd trimesters\n* Total hysterectomy; absence of a vagina\n* Women under guardianship\u002Ftutelage",true,"FEMALE","30 Years","65 Years",{"count":82,"type":20},700,"INTERVENTIONAL",[85],"NA","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.\n\nIt 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).\n\nHPV positive participants will receive counseiling and guidance to help them find a healthcare professional to take care of their needs",[88],"Women's Health: Cervical Neoplasm",[90,91,92,93],"HPV","cervical cancer","outreach intervention","vaginal self sampling","2024-10-23",{"date":96,"type":36},"2024-10-24",{"date":98,"type":20},"2024-12-01",{"date":100,"type":20},"2026-07-30",{"name":42,"class":43},1,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":83,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":102},"100565993","determination-of-new-detection-and-quantification-thresholds-for-serological-and-molecular-tests-for-hepatitis-delta-virus-hdv-using-capillary-blood-on-blotting-paper-dbs-100565993","NCT06649396","Determination of New Detection and Quantification Thresholds for Serological and Molecular Tests for Hepatitis Delta Virus (HDV) Using Capillary Blood on Blotting Paper (DBS)","SACADE","Inclusion Criteria:\n\n* Adult patients (18 years old and above)\n* Patient infected by the Hepatitis Delta Virus (HDV positive serology)\n* Patient followed by one of the participating APHP hospitals' hepatology department\n* Patient for whom peripheral blood sampling is already planned as part of their medical follow-up.\n* Free, informed and signed consent.\n\nExclusion Criteria:\n\n* Patient without blood sampling scheduled as part of medical follow-up.\n* Patient with a condition that makes fingertip capillary puncture impossible.\n* Patient refusing to participate in the study",{"count":111,"type":20},120,[85],"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).\n\nHistorically, 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.\n\nDetection of HDV typically involves serological tests (ELISA\u002FCLIA) 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.\n\nIn 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.\n\nGiven 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\u002Fquantification in molecular biology for serum\u002Fplasma and EDTA whole blood on DBS.\n\nTo 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.\n\nThe 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.\n\nBy 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.",[115],"Delta Hepatitis",[117,118,115,119,120,121],"Dried Blood Spot","DBS","HDV","Viral load","Serology","2024-10-17",{"date":124,"type":36},"2024-10-18",{"date":126,"type":20},"2024-11-30",{"date":128,"type":20},"2026-07-01",{"name":42,"class":43},""]