protocolSection identificationModule nctId: NCT06273943, orgStudyIdInfo id: ANRS 0410s CABOPrEP, secondaryIdInfos id: 2024-510678-25, type: EUDRACT_NUMBER, briefTitle: Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France., acronym: CABOPrEP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2026-10-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: ANRS, Emerging Infectious Diseases, class: OTHER_GOV, descriptionModule 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., conditionsModule conditions: Prevention, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo 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, maskingInfo masking: NONE, enrollmentInfo count: 322, type: ESTIMATED, armsInterventionsModule interventions name: Cabotegravir Tablets, for oral use., interventions name: Cabotegravir Extended-Release Injectable Suspension, for intramuscular use., interventions name: Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use, interventions name: Rectal Biopsies, outcomesModule primaryOutcomes measure: Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm., secondaryOutcomes measure: Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm., secondaryOutcomes 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., secondaryOutcomes measure: Number of participants whose last condomless anal sexual intercourse was not covered by PrEP., secondaryOutcomes measure: Number of condomless anal sexual intercourse in the month prior to each study visit., secondaryOutcomes measure: Number of sexual partners in the last 3 months., secondaryOutcomes measure: Mean PrEP satisfaction score based on study arm., secondaryOutcomes measure: Number of participants with syphilis, chlamydiae, and/or gonorrhea infection., secondaryOutcomes measure: Number of participants with Grade 2 or higher clinical or laboratory drug-related adverse events at any time during the study., secondaryOutcomes measure: Change from baseline in body weight (kg)., secondaryOutcomes measure: Change from baseline in lipids, secondaryOutcomes measure: Change from baseline in the insulin resistance index (HOMA-IR)., secondaryOutcomes measure: Number and severity of injection site reaction., secondaryOutcomes measure: Cabotegravir concentration in plasma and tenofovir diphosphate and emtricitabine triphosphate concentration in dried blood spots., secondaryOutcomes measure: Number of participants with new HIV infection., secondaryOutcomes measure: Number of participants who used psychoactive drugs in the last 3 months, secondaryOutcomes measure: Score of quality of life measured by the EuroQol-5D questionnaire, secondaryOutcomes measure: Depression score assessed with the Center for Epidemiologic Studies Depression Scale (CES-D)., secondaryOutcomes measure: Self-esteem score assessed with the Rosenberg scale., secondaryOutcomes measure: Number and nature of uses of community peer support and therapeutic patient education., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Hôtel Dieu, city: Paris, state: Ile De France, zip: 75004, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Lariboisière, city: Paris, state: Ile De France, zip: 75010, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Saint Louis, city: Paris, state: Ile De France, zip: 75010, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Saint Antoine, city: Paris, state: Ile De France, zip: 75012, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital La Pitié Salpêtrière, city: Paris, state: Ile De France, zip: 75013, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Necker, city: Paris, state: Ile De France, zip: 75015, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Bichat, city: Paris, state: Ile De France, zip: 75018, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Tenon, city: Paris, state: Ile De France, zip: 75020, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False