Pain From HIV Injections Given in Two Body Sites, With or Without VR Headset
Compares injection pain of two HIV medicines in adults with HIV.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- La Roche-sur-Yon, Le Coudray, Nantes, Orléans, and Poitiers, FranceSee the 5 sites
Where in France
- CHD VendéeLa Roche-sur-Yon, FranceTaking people
- CH ChartresLe Coudray, FranceTaking people
- CHU NantesNantes, FranceTaking people
- Center Hospitalier Universitaire d'OrléansOrléans, FranceTaking people
- CHU PoitiersPoitiers, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Régional d'Orléans
- Trial code
- NCT06834113
- Record updated
- 30 December 2025
- Original description
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.Read full original descriptionShow less
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
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 injectable antiretroviral.
The 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.
Inclusion: 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: Patient participating in another clinical trial with medication; Patient(s) with epilepsy; 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) on another injectable antiretroviral treatment; Patient on antidepressant treatment; 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.