RecruitingNot ApplicableNCT06834113

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

Sponsor

Centre Hospitalier Régional d'Orléans

Enrollment

120 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

HIV I Infection Injection Pain

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether the injection site (two different areas of the buttocks) and the use of a virtual reality headset can reduce pain from long-acting injectable HIV treatment — specifically cabotegravir and rilpivirine injections given every 1–2 months. **You may be eligible if...** - You are at least 18 years old - You are living with HIV-1 and your viral load is undetectable (under 50 copies/ml) - You are scheduled to start or are currently receiving long-acting injectable HIV treatment (cabotegravir + rilpivirine) **You may NOT be eligible if...** - You are on a different type of injectable HIV treatment - You are currently enrolled in another medication trial - You have epilepsy - You take antidepressant medications - You have a psychiatric or behavioral disorder - You have a history of severe dizziness, motion sickness, or visual/hearing impairment that would prevent you from using a VR headset Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDorsogluteal intramuscular injection

The 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