[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580193":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":49,"studyPopulation":40,"armGroups":50,"interventions":126,"overallOfficials":136,"centralContacts":141,"locations":151,"responsibleParty":223,"collaborators":40,"id":225,"slug":40,"hasResults":226,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":226,"sex":232,"minAge":233,"maxAge":40,"enrollmentInfo":234,"targetDuration":40,"studyType":237,"phases":238,"briefSummary":240,"conditions":241,"keywords":40,"overallStatus":154,"whyStopped":40,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},{"fullName":5,"class":6},"Centre Hospitalier Régional d'Orléans","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Intensity of pain induced by injectable ARV (Cabotegravir and Rilpivirine) in patients infected with HIV-1, depending on the injection site and whether or not a virtual reality headset is used.","Composite criterion integrating the measurement of immediate and remote post-injection pain (within 7 days following antiretroviral injections) using a numerical scale from 0 to 10, with immediate post-injection measurement, a second measurement on the first day 6-8 hours after injection then a daily measurement for 7 days.\n\nThe composite criterion will aim to consider pain globally, that is to say all the measurements over 7 days. It is therefore based on the area under the curve of the pain measurement points, normalized by the number of measurement days. This helps increase the first day pain weight, which includes 2 measurements. In practice, this amounts to the sum of the pain measurements (up to 8 measurements in total in absence of missing data), divided by the number of days of measurement (up to 7 days, in the absence of missing data).","The pain will be self-assessed immediately after the injection, 6-8 hours after the injection, and once a day for the following seven days.",[14,18,21,24,27,30,33,37],{"measure":15,"description":16,"timeFrame":17},"Detect the influence of sex on the perception of pain induced by antiretroviral injection.","Measurement of post-injection pain (immediate and remote) with one VAS scale (from 0 to 10 with 10 being the worst score) between different patients under dorsogluteal or ventrogluteal with or without virtual reality headset depending on sex","immediately after the injection; 6-8 hours after the injection; every day for 7 days; at the last visit for each patient (at 7-8 months after inclusion)",{"measure":19,"description":20,"timeFrame":17},"Detect the influence of age on the perception of pain induced by antiretroviral injection.","Measurement of post-injection pain (immediate and remote) with one VAS scale (from 0 to 10 with 10 being the worst score) between different patients under dorsogluteal or ventrogluteal with or without virtual reality headset depending on age",{"measure":22,"description":23,"timeFrame":17},"Detect the influence of BMI on the perception of pain induced by antiretroviral injection.","Measurement of post-injection pain (immediate and remote) with one VAS scale (from 0 to 10 with 10 being the worst score) between different patients under dorsogluteal or ventrogluteal with or without virtual reality headset depending on BMI",{"measure":25,"description":26,"timeFrame":17},"Detect the influence of number of injections on the perception of pain induced by antiretroviral injection.","Measurement of post-injection pain (immediate and remote) with one VAS scale (from 0 to 10 with 10 being the worst score) between different patients under dorsogluteal or ventrogluteal with or without virtual reality headset depending on number of injections",{"measure":28,"description":29,"timeFrame":17},"Compare treatment tolerance depending on the injection site and whether or not a virtual reality headset is worn. The reference group being the dorsogluteal injection without headset","Compare all adverse events depending on the injection site and whether or not a virtual reality headset is worn. The reference group being the dorsogluteal injection without headset",{"measure":31,"description":32,"timeFrame":17},"Evaluate the representativeness of the cohort of patients treated with injectables, compared to all patients treated for HIV, particularly in terms of gender and ethnic origins, in order to identify indication biases","Evaluate the representativeness of the cohort of patients treated with injectables, compared to all patients treated for HIV. Proportion of different ethnic origins and different genders in patients to identify indication biases",{"measure":34,"description":35,"timeFrame":36},"Evaluate the satisfaction of the professionals who will perform the injections with a questionnaire","Evaluate the satisfaction of the professionals who will perform the injections : two questions one on preference (preferred procedure per nurse : A or B or C or D) and one on number (number of procedures per nurse).","at the last visit for each patient (at 7-8 months after inclusion)",{"measure":38,"description":39,"timeFrame":36},"Evaluate patient satisfaction about injection procedures with questionnaire","Evaluate patient satisfaction with injection procedures : one question (which procedure patient prefers : A or B or C or D)",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":40,"timePerspective":40,"maskingInfo":46},"RANDOMIZED","CROSSOVER","This is a multicenter, randomized, open-label study with a cross-over design. Eeach participant will serve as their own control and will randomly experience the four intramuscular injection procedures of injectable ARV.","PREVENTION",{"masking":47,"maskingDescription":48,"whoMasked":40},"NONE","Non applicable","Five visits will be performed as a standard of care:\n\nInclusion visit: After checking of the eligibility, patient is informed of the study and an informed note is given. Injection site is examined. If the patient agrees, consent is collected.\n\nVisit D0 (all the patients): examination of the injection zone by the nurse, collection of concomitant treatments (only analgesics and anti-inflammatory drugs) taken by the patient, CAB+RPV injections according to the randomization arm, completion of the numerical scale by the patient following ARV injections, submission of the patient log for the assessment of pain by the patient during the 7 days following the ARV injections.\n\nFollow-up visits (M1, M3, M5 for naïve patients and M2, M4, M6 for treatment-experienced patients): recovery of the patient log with assessment of pain on previous injection, collection of concomitants treatments and adverse events, examination of the injection site by the nurse, injection according the randomization arm, completion of the numerical scale by the patient following the injections, delivery of a new patient note.\n\nEnd of study visit: recovery of the patient log with assessment of pain on previous injection, collection of concomitants treatments and adverse events, questioning the study procedures, patient's preferred choice between the different injection procedures.\n\nFor the research needs,\n\n* The injection site (ventrogluteal and dorsogluteal) will be chosen, by randomisation\n* Wearing a virtual reality headset A patient log to assess pain, using a numerical scale (1 to 10), will be filled out by the patient",[51,57,60,63,66,69,72,75,78,81,84,87,90,93,96,99,102,105,108,111,114,117,120,123],{"label":52,"type":53,"description":54,"interventionNames":55},"DCBA (specific order of procedures with type of injection site and\u002For use virtual reality headset)","EXPERIMENTAL","A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset",[56],"Procedure: Dorsogluteal intramuscular injection",{"label":58,"type":53,"description":54,"interventionNames":59},"CDBA (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":61,"type":53,"description":54,"interventionNames":62},"DBCA (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":64,"type":53,"description":54,"interventionNames":65},"BDCA (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":67,"type":53,"description":54,"interventionNames":68},"CBDA (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":70,"type":53,"description":54,"interventionNames":71},"BCDA (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":73,"type":53,"description":54,"interventionNames":74},"DCAB (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":76,"type":53,"description":54,"interventionNames":77},"CDAB (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":79,"type":53,"description":54,"interventionNames":80},"DACB (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":82,"type":53,"description":54,"interventionNames":83},"ADCB (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":85,"type":53,"description":54,"interventionNames":86},"CADB (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":88,"type":53,"description":54,"interventionNames":89},"ACDB (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":91,"type":53,"description":54,"interventionNames":92},"DBAC (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":94,"type":53,"description":54,"interventionNames":95},"BDAC (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":97,"type":53,"description":54,"interventionNames":98},"DABC (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":100,"type":53,"description":54,"interventionNames":101},"ADBC (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":103,"type":53,"description":54,"interventionNames":104},"BADC (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":106,"type":53,"description":54,"interventionNames":107},"ABDC (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":109,"type":53,"description":54,"interventionNames":110},"CBAD (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":112,"type":53,"description":54,"interventionNames":113},"BCAD (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":115,"type":53,"description":54,"interventionNames":116},"CABD (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":118,"type":53,"description":54,"interventionNames":119},"ACBD (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":121,"type":53,"description":54,"interventionNames":122},"BACD (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],{"label":124,"type":53,"description":54,"interventionNames":125},"ABCD (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[56],[127],{"type":128,"name":129,"description":130,"armGroupLabels":131,"otherNames":132},"PROCEDURE","Dorsogluteal intramuscular injection","The injection is carried out on the dorsogluteal intramuscular site, without virtual reality headset\n\nThe injection is carried out on the ventrogluteal intramuscular site, without virtual reality headset\n\nThe injection is carried out on the dorsogluteal intramuscular site, with virtual reality headset\n\nThe injection is carried out on the ventrogluteal intramuscular site, with virtual reality headset",[124,106,118,88,100,82,121,103,112,70,94,64,115,85,109,67,76,58,97,79,91,61,73,52],[133,134,135],"Ventrogluteal intramuscular injection","Dorsogluteal intramuscular injection with virtual reality headset","Ventro-gluteal intramuscular injection with virtual reality headset",[137],{"name":138,"affiliation":139,"role":140},"Daniela PIRES ROTEIA","CHU Orléans","PRINCIPAL_INVESTIGATOR",[142,147],{"name":138,"role":143,"phone":144,"phoneExt":145,"email":146},"CONTACT","02 38 65 13 38","+33","daniela.pires-roteia@chu-orleans.fr",{"name":148,"role":143,"phone":149,"phoneExt":145,"email":150},"Fanny LOUAT","02 38 74 42 95","fanny.louat@chu-orleans.fr",[152,169,182,196,210],{"facility":153,"status":154,"city":155,"state":156,"zip":157,"country":158,"countryCode":159,"cosmosGeoPoint":160,"geoPoint":165,"contacts":166},"Center Hospitalier Universitaire d'Orléans","RECRUITING","Orléans","Loiret","45067","France","FR",{"type":161,"coordinates":162},"Point",[163,164],1.90407,47.90248,{"lat":164,"lon":163},[167],{"name":138,"role":143,"phone":168,"phoneExt":40,"email":146},"0238651338",{"facility":170,"status":154,"city":171,"state":40,"zip":172,"country":158,"countryCode":159,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"CHD Vendée","La Roche-sur-Yon","85925",{"type":161,"coordinates":174},[175,176],-1.42757,46.66974,{"lat":176,"lon":175},[179],{"name":180,"role":143,"phone":40,"phoneExt":145,"email":181},"Dominique MERRIEN, Dr","dominique.merrien@ght85.fr",{"facility":183,"status":154,"city":184,"state":40,"zip":185,"country":158,"countryCode":159,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"CH Chartres","Le Coudray","28630",{"type":161,"coordinates":187},[188,189],1.50057,48.42115,{"lat":189,"lon":188},[192],{"name":193,"role":143,"phone":194,"phoneExt":145,"email":195},"Iuliana DARASTEANU, Dr","0237303030","idarasteanu@ch-chartres.fr",{"facility":197,"status":154,"city":198,"state":40,"zip":199,"country":158,"countryCode":159,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"CHU Nantes","Nantes","44093",{"type":161,"coordinates":201},[202,203],-1.55336,47.21725,{"lat":203,"lon":202},[206],{"name":207,"role":143,"phone":208,"phoneExt":145,"email":209},"Clotilde ALLAVENA, Dr","0240083109","clotilde.allavena@chu-nantes.fr",{"facility":211,"status":154,"city":212,"state":40,"zip":213,"country":158,"countryCode":159,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"CHU Poitiers","Poitiers","90577",{"type":161,"coordinates":215},[216,217],0.34348,46.58261,{"lat":217,"lon":216},[220],{"name":221,"role":143,"phone":40,"phoneExt":40,"email":222},"Gwenaël LE MOAL, Dr","gwenael.lemoal@chu-poitiers.fr",{"type":224,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100580193",false,"NCT06834113","Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset","Impact of Two Types of Interventions (Ventrogluteal Versus Dorsogluteal Injection Site; Virtual Reality Headset: Presence or Absence) on Pain After Injections of Vocabria® (Cabotegravir) and Rekambys® (Rilpivirine) in Patients Infected With Human Immunodeficiency Virus -1","VIHINJECT","Inclusion Criteria:\n\n* Patient aged at least 18 years;\n* Patient infected with HIV-1;\n* Patient virologically controlled (VL \\\u003C 50 copies\u002Fml);\n* Patient scheduled to receive treatment with cabotegravir and rilpivirine (naïve patients) or currently on injectable cabotegravir and rilpivirine, prescribed by their referring physician.\n\nExclusion Criteria:\n\n* Patient(s) on another injectable antiretroviral treatment;\n* Patient participating in another clinical trial with medication;\n* Patient(s) with epilepsy;\n* Patient on antidepressant treatment;\n* Patient(s) with psychiatric or behavioral disorders;\n* Patient(s) with a history of dizziness and motion sickness that prevents the use of virtual reality headset;\n* Patient(s) with visual and hearing impairments that prevent the use of virtual reality headset;\n* Patient(s) deprived of liberty, under guardianship or under curatorship;\n* Patient(s) not affiliated with a social security scheme;\n* Pregnant or breastfeeding women.","ALL","18 Years",{"count":235,"type":236},120,"ESTIMATED","INTERVENTIONAL",[239],"NA","This is a multicenter, randomized, open-label study with a cross-over design. The objective of this project is to compare the intensity of pain induced by injectable antiretroviral (ARV) treatment (Cabotegravir® and Rilpivirine®) in patients infected with HIV-1, depending on the injection site and whether or not they are wearing a virtual reality headset. The reference group being the dorsogluteal injection without headset.\n\nParticipants who meet the study criteria will be randomized into 1 of 24 sequences. A sequence is composed by 4 injections procedures: dorsogluteal intramuscular injection (A), ventrogluteal intramuscular injection (B), dorsogluteal intramuscular injection with virtual reality headset (C), ventrogluteal intramuscular injection with virtual reality headset (D).\n\nEach patient will be their own witness and will experience the 4 intramuscular injection procedures of injectable antiretroviral.\n\nThe study population are patients carrying HIV-1 and being monitored for this pathology, eligible (naïve patients) or already under Cabotegravir® (CAB) and Rilpivirine® (RPV) injectable treatment.",[242,243],"HIV I Infection","Injection Pain","2025-12-22",{"date":246,"type":247},"2025-12-30","ACTUAL",{"date":249,"type":247},"2025-01-24",{"date":251,"type":236},"2026-09-24",{"name":5,"class":6},5]