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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

RecruitingNAAges 18 Years - anyAllCentre Hospitalier Régional d'Orléans
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In plain words

What the trial is, and whether it could suit you

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. Participants 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). Each patient will be their own witness and will experience the 4 intramuscular injection procedures of inje

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient aged at least 18 years; * Patient infected with HIV-1; * Patient virologically controlled (VL \< 50 copies/ml); * Patient scheduled to receive treatment with cabotegravir and rilpivirine (naïve patients) or currently on injectable cabotegravir and rilpivirine, prescribed by their referring physician. Exclusion Criteria: * Patient(s) on another injectable antiretroviral treatment; * Patient participating in another clinical trial with medication; * Patient(s) with epilepsy; * Patient on antidepressant treatment; * Patient(s) with psychiatric or behavioral disorders; * Patient(s) with a history of dizziness and motion sickness that prevents the use of virtual reality headset; * Patient(s) with visual and hearing impairments that prevent the use of virtual reality headset; * Patient(s) deprived of liberty, under guardianship or under curatorship; * Patient(s) not affiliated with a social security scheme; * Pregnant or breastfeeding women.
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What it tests

  • Dorsogluteal intramuscular injection
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Where

5 sites
Center Hospitalier Universitaire d'Orléans
Orléans, France
CHD Vendée
La Roche-sur-Yon, France
CH Chartres
Le Coudray, France
CHU Nantes
Nantes, France
CHU Poitiers
Poitiers, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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