Clinical trial NCT06834113: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV I Infection
Injection Pain
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a multicenter, randomized, open-label study with a cross-over design. Eeach participant will serve as their own control and will randomly experience the four intramuscular injection procedures of injectable ARV.
Primary purpose: PREVENTION

Brief 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.

Detailed 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

Eligibility criteria: 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 (naïve patients) or currently on injectable cabotegravir and rilpivirine, prescribed by their referring physician.

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 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.

Primary outcomes:
measure: 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.
timeFrame: The pain will be self-assessed immediately after the injection, 6-8 hours after the injection, and once a day for the following seven days.
Secondary outcomes:
measure: Detect the influence of sex on the perception of pain induced by antiretroviral injection.
timeFrame: immediately after the injection; 6-8 hours after the injection; every day for 7 days; at the last visit for each patient (at 7-8 months after inclusion)
measure: Detect the influence of age on the perception of pain induced by antiretroviral injection.
timeFrame: immediately after the injection; 6-8 hours after the injection; every day for 7 days; at the last visit for each patient (at 7-8 months after inclusion)
measure: Detect the influence of BMI on the perception of pain induced by antiretroviral injection.
timeFrame: immediately after the injection; 6-8 hours after the injection; every day for 7 days; at the last visit for each patient (at 7-8 months after inclusion)
measure: Detect the influence of number of injections on the perception of pain induced by antiretroviral injection.
timeFrame: immediately after the injection; 6-8 hours after the injection; every day for 7 days; at the last visit for each patient (at 7-8 months after inclusion)
measure: Compare treatment tolerance depending on the injection site and whether or not a virtual reality headset is worn. The reference group being the dorsogluteal injection without headset
timeFrame: immediately after the injection; 6-8 hours after the injection; every day for 7 days; at the last visit for each patient (at 7-8 months after inclusion)
measure: Evaluate the representativeness of the cohort of patients treated with injectables, compared to all patients treated for HIV, particularly in terms of gender and ethnic origins, in order to identify indication biases
timeFrame: immediately after the injection; 6-8 hours after the injection; every day for 7 days; at the last visit for each patient (at 7-8 months after inclusion)
measure: Evaluate the satisfaction of the professionals who will perform the injections with a questionnaire
timeFrame: at the last visit for each patient (at 7-8 months after inclusion)
measure: Evaluate patient satisfaction about injection procedures with questionnaire
timeFrame: at the last visit for each patient (at 7-8 months after inclusion)
Other outcomes:
Locations:
city: Orléans
country: France
facility: Center Hospitalier Universitaire d'Orléans
state: Loiret
city: Le Coudray
country: France
facility: CH Chartres
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: CHU Orléans
name: Daniela PIRES ROTEIA
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Roldan-Chicano MT, Rodriguez-Tello J, Cebrian-Lopez R, Moore JR, Del Mar Garcia-Lopez M. Adverse effects of dorsogluteal intramuscular injection versus ventrogluteal intramuscular injection: A systematic review and meta-analysis. Nurs Open. 2023 Sep;10(9):5975-5988. doi: 10.1002/nop2.1902. Epub 2023 Jul 14.
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