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

Inclusion Criteria4

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 Criteria10

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.

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