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

Last updated: February 18, 2025
Sponsor: Centre Hospitalier Régional d'Orléans
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Dorsogluteal intramuscular injection

Clinical Study ID

NCT06834113
CH Orléans
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 (naïvepatients) or currently on injectable cabotegravir and rilpivirine, prescribed bytheir referring physician.

Exclusion

Exclusion Criteria:

  • 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 ofvirtual reality headset;

  • Patient(s) with visual and hearing impairments that prevent the use of virtualreality headset;

  • Patient(s) deprived of liberty, under guardianship or under curatorship;

  • Patient(s) not affiliated with a social security scheme;

  • Pregnant or breastfeeding women.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Dorsogluteal intramuscular injection
Phase:
Study Start date:
January 24, 2025
Estimated Completion Date:
September 24, 2026

Study Description

Five visits will be performed as a standard of care:

Inclusion visit: After checking of the eligibility, patient is informed of the study and an informed note is given. Injection site is examined. If the patient agrees, consent is collected.

Visit D0 (all the patients): examination of the injection zone by the nurse, collection of concomitant treatments (only analgesics and anti-inflammatory drugs) taken by the patient, CAB+RPV injections according to the randomization arm, completion of the numerical scale by the patient following ARV injections, submission of the patient log for the assessment of pain by the patient during the 7 days following the ARV injections.

Follow-up visits (M1, M3, M5 for naïve patients and M2, M4, M6 for treatment-experienced patients): recovery of the patient log with assessment of pain on previous injection, collection of concomitants treatments and adverse events, examination of the injection site by the nurse, injection according the randomization arm, completion of the numerical scale by the patient following the injections, delivery of a new patient note.

End of study visit: recovery of the patient log with assessment of pain on previous injection, collection of concomitants treatments and adverse events, questioning the study procedures, patient's preferred choice between the different injection procedures.

For the research needs,

  • The injection site (ventrogluteal and dorsogluteal) will be chosen, by randomisation

  • Wearing a virtual reality headset A patient log to assess pain, using a numerical scale (1 to 10), will be filled out by the patient

Connect with a study center

  • Center Hospitalier Universitaire d'Orléans

    Orléans, Loiret 45067
    France

    Active - Recruiting

  • CH Chartres

    Le Coudray, 28630
    France

    Site Not Available

  • CHU Nantes

    Nantes, 44093
    France

    Site Not Available

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