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.
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.
Patient(s) on another injectable antiretroviral treatment;
Patient participating in another clinical trial with medication;
Patient(s) with epilepsy;
Patient on antidepressant treatment;
Crossover
Dorsogluteal intramuscular injection
Procedure/SurgeryThe injection is carried out on the dorsogluteal intramuscular site, without virtual reality headset The injection is carried out on the ventrogluteal intramuscular site, without virtual reality headset The injection is carried out on the dorsogluteal intramuscular site, with virtual reality headset The injection is carried out on the ventrogluteal intramuscular site, with virtual reality headset
24
Treatment groupsSee each treatment group below.
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. The 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).
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
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
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
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
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