nctId: NCT06273943 id: ANRS 0410s CABOPrEP id: 2024-510678-25 type: EUDRACT_NUMBER briefTitle: Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France. acronym: CABOPrEP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-30 date: 2026-10-30 date: 2024-02-23 date: 2024-02-23 name: ANRS, Emerging Infectious Diseases class: OTHER_GOV briefSummary: The purpose of this study is to evaluate if offering long-acting injectable cabotegravir (CAB-LA) as an additional HIV prevention choice among oral PrEP-experienced men who have sex with men (MSM) in France can significantly increase the sustained PrEP use over time and the PrEP coverage of at-risk sexual risk behaviors. conditions: Prevention studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned in a 1:1 ratio to remain on their current oral PrEP regimen with daily and/or on-demand TDF/FTC (Control arm) or to switch to a CAB-LA based PrEP (Intervention arm). primaryPurpose: PREVENTION masking: NONE count: 322 type: ESTIMATED name: Cabotegravir Tablets, for oral use. name: Cabotegravir Extended-Release Injectable Suspension, for intramuscular use. name: Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use name: Rectal Biopsies measure: Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm. measure: Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm. measure: Number of participants with missing follow-up visits, temporary PrEP discontinuation, permanent PrEP discontinuation, switching to another PrEP regimen, study discontinuation, lost to follow-up. measure: Number of participants whose last condomless anal sexual intercourse was not covered by PrEP. measure: Number of condomless anal sexual intercourse in the month prior to each study visit. measure: Number of sexual partners in the last 3 months. measure: Mean PrEP satisfaction score based on study arm. measure: Number of participants with syphilis, chlamydiae, and/or gonorrhea infection. measure: Number of participants with Grade 2 or higher clinical or laboratory drug-related adverse events at any time during the study. measure: Change from baseline in body weight (kg). measure: Change from baseline in lipids measure: Change from baseline in the insulin resistance index (HOMA-IR). measure: Number and severity of injection site reaction. measure: Cabotegravir concentration in plasma and tenofovir diphosphate and emtricitabine triphosphate concentration in dried blood spots. measure: Number of participants with new HIV infection. measure: Number of participants who used psychoactive drugs in the last 3 months measure: Score of quality of life measured by the EuroQol-5D questionnaire measure: Depression score assessed with the Center for Epidemiologic Studies Depression Scale (CES-D). measure: Self-esteem score assessed with the Rosenberg scale. measure: Number and nature of uses of community peer support and therapeutic patient education. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Hôtel Dieu city: Paris state: Ile De France zip: 75004 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Lariboisière city: Paris state: Ile De France zip: 75010 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Saint Louis city: Paris state: Ile De France zip: 75010 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Saint Antoine city: Paris state: Ile De France zip: 75012 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital La Pitié Salpêtrière city: Paris state: Ile De France zip: 75013 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Necker city: Paris state: Ile De France zip: 75015 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Bichat city: Paris state: Ile De France zip: 75018 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Tenon city: Paris state: Ile De France zip: 75020 country: France lat: 48.85341 lon: 2.3488 hasResults: False