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

Not Applicable

Recruiting

• Conditions: HIV I Infection; Injection Pain

• Registration Number: NCT06834113
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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

Study Timeline

• Study Start: 2025-01-24
• Study First Submitted: 2025-01-31
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-07-24
• Study Completion: 2026-09-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.	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.	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).

Secondary Outcome Measures

Name	Time	Method
Evaluate the satisfaction of the professionals who will perform the injections with a questionnaire	at the last visit for each patient (at 7-8 months after inclusion)	Evaluate the satisfaction of the professionals who will perform the injections : one questionnaire
Detect the influence of other parameters on the perception of pain (sex, age, BMI, number of injections…) induced by antiretroviral injection.	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)	Measurement of post-injection pain (immediate and remote) between different patients under dorsogluteal or ventrogluteal with or without virtual reality headset depending on other parameters (sex, age, BMI, number of injections...)
Compare the number and intensity of adverse events depending on the injection site and whether or not a virtual reality headset is worn. The reference group being the dorsogluteal injection without headset	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)	Compare the number and intensity of adverse events depending on the injection site and whether or not a virtual reality headset is worn. The reference group being the dorsogluteal injection without headset
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	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)	Evaluate the representativeness of the cohort of patients treated with injectables, compared to all patients treated for HIV. Proportion of different ethnic origins and different genders in patients to identify indication biases
Evaluate patient satisfaction about injection procedures with questionnaire	at the last visit for each patient (at 7-8 months after inclusion)	Evaluate patient satisfaction with injection procedures : one question (which procedure patient prefers)

Trial Locations

Locations (3)

Center Hospitalier Universitaire d'Orléans; 🇫🇷 Orléans, Loiret, France

CH Chartres; 🇫🇷 Le Coudray, France

CHU Nantes; 🇫🇷 Nantes, France