About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patient(s) on another injectable antiretroviral treatment;
Patient participating in another clinical trial with medication;
Patient(s) with epilepsy;
Patient on antidepressant treatment;
Trial design
Treatments tested in this trial
- Dorsogluteal intramuscular injection
Treatment groups
24
Treatment groupsSee each treatment group below.