HIV I InfectionVIHINJECTNCT06834113
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
A study testing Dorsogluteal intramuscular injection in people with HIV I Infection and Injection Pain, run by Centre Hospitalier Régional d'Orléans at 5 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV I Infection, Injection Pain
- What is being tested?
- Dorsogluteal intramuscular injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesFrance
- Study dates
- 24 Jan 2025to 24 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHD Vendée
La Roche-sur-Yon, 85925
Dominique MERRIEN, Dr, dominique.merrien@ght85.fr
- Recruiting
CH Chartres
Le Coudray, 28630
Iuliana DARASTEANU, Dr, 0237303030 ext. +33, idarasteanu@ch-chartres.fr
- Recruiting
CHU Nantes
Nantes, 44093
Clotilde ALLAVENA, Dr, 0240083109 ext. +33, clotilde.allavena@chu-nantes.fr
- Recruiting
Center Hospitalier Universitaire d'Orléans
Orléans, Loiret, 45067
Daniela PIRES ROTEIA, 0238651338, daniela.pires-roteia@chu-orleans.fr
- Recruiting
CHU Poitiers
Poitiers, 90577
Gwenaël LE MOAL, Dr, gwenael.lemoal@chu-poitiers.fr
About this study
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
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).
Read more
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.
Read the 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
- Conditions
- HIV I Infection, Injection Pain
- Being tested
- Dorsogluteal intramuscular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsogluteal intramuscular injectionProcedure or surgery
Also called Ventrogluteal intramuscular injection, Dorsogluteal intramuscular injection with virtual reality headset, Ventro-gluteal intramuscular injection with virtual reality headset
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
| Study group | Role | What they receive |
|---|---|---|
| DCBA (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| CDBA (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| DBCA (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| BDCA (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| CBDA (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| BCDA (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| DCAB (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| CDAB (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| DACB (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| ADCB (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| CADB (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| ACDB (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| DBAC (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| BDAC (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| DABC (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| ADBC (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| BADC (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| ABDC (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| CBAD (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| BCAD (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| CABD (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| ACBD (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| BACD (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
| ABCD (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset Receives: Procedure: Dorsogluteal intramuscular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: 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 (8)
Detect the influence of sex on the perception of pain induced by antiretroviral injection.
Measurement of post-injection pain (immediate and remote) with one VAS scale (from 0 to 10 with 10 being the worst score) between different patients under dorsogluteal or ventrogluteal with or without virtual reality headset depending on sex
Measured: 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)
Detect the influence of age on the perception of pain induced by antiretroviral injection.
Measurement of post-injection pain (immediate and remote) with one VAS scale (from 0 to 10 with 10 being the worst score) between different patients under dorsogluteal or ventrogluteal with or without virtual reality headset depending on age
Measured: 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)
Detect the influence of BMI on the perception of pain induced by antiretroviral injection.
Measurement of post-injection pain (immediate and remote) with one VAS scale (from 0 to 10 with 10 being the worst score) between different patients under dorsogluteal or ventrogluteal with or without virtual reality headset depending on BMI
Measured: 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)
Detect the influence of number of injections on the perception of pain induced by antiretroviral injection.
Measurement of post-injection pain (immediate and remote) with one VAS scale (from 0 to 10 with 10 being the worst score) between different patients under dorsogluteal or ventrogluteal with or without virtual reality headset depending on number of injections
Measured: 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 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
Compare all 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
Measured: 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, particularly in terms of gender and ethnic origins, in order to identify indication biases
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
Measured: 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 satisfaction of the professionals who will perform the injections with a questionnaire
Evaluate the satisfaction of the professionals who will perform the injections : two questions one on preference (preferred procedure per nurse : A or B or C or D) and one on number (number of procedures per nurse).
Measured: at the last visit for each patient (at 7-8 months after inclusion)
Evaluate patient satisfaction about injection procedures with questionnaire
Evaluate patient satisfaction with injection procedures : one question (which procedure patient prefers : A or B or C or D)
Measured: at the last visit for each patient (at 7-8 months after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start24 Jan 2025
- Primary completion24 Jul 2026 (estimated)
- Study completion24 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV I InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela PIRES ROTEIA, Principal investigator, CHU Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834113
- Sponsor's protocol ID
- CHUO-2024-15
- Acronym
- VIHINJECT
- Status last verified
- Dec 2025
- First submitted
- 31 Jan 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jonsson-Oldenbuttel C, Ghosn J, van der Valk M, Florence E, Vera F, De Wit S, Rami A, Bonnet F, Hocqueloux L, Hove K, Ait-Khaled M, DeMoor R, Bontempo G, Latham CL, Gutner CA, Iyer S, Gill M, Czarnogorski M, D'Amico R, van Wyk J. Safety and Effectiveness From the Cabotegravir and Rilpivirine Implementation Study in European Locations Study: Phase 3b Hybrid Type III Implementation Study Integrating Cabotegravir + Rilpivirine Long-Acting Into European Clinical Settings. J Acquir Immune Defic Syndr. 2024 Aug 15;96(5):472-480. doi: 10.1097/QAI.0000000000003448. Epub 2024 Jul 9.
PubMed 38985445Larkin TA, Ashcroft E, Elgellaie A, Hickey BA. Ventrogluteal versus dorsogluteal site selection: A cross-sectional study of muscle and subcutaneous fat thicknesses and an algorithm incorporating demographic and anthropometric data to predict injection outcome. Int J Nurs Stud. 2017 Jun;71:1-7. doi: 10.1016/j.ijnurstu.2017.02.017. Epub 2017 Feb 22.
PubMed 28273627Gao Y, Xu Y, Liu N, Fan L. Effectiveness of virtual reality intervention on reducing the pain, anxiety and fear of needle-related procedures in paediatric patients: A systematic review and meta-analysis. J Adv Nurs. 2023 Jan;79(1):15-30. doi: 10.1111/jan.15473. Epub 2022 Nov 3.
PubMed 36330583Chuan A, Zhou JJ, Hou RM, Stevens CJ, Bogdanovych A. Virtual reality for acute and chronic pain management in adult patients: a narrative review. Anaesthesia. 2021 May;76(5):695-704. doi: 10.1111/anae.15202. Epub 2020 Jul 27.
PubMed 32720308Roldan-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.
PubMed 37452553Larkin TA, Ashcroft E, Hickey BA, Elgellaie A. Influence of gender, BMI and body shape on theoretical injection outcome at the ventrogluteal and dorsogluteal sites. J Clin Nurs. 2018 Jan;27(1-2):e242-e250. doi: 10.1111/jocn.13923. Epub 2017 Nov 20.
PubMed 28618093
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06834113
- Acronym / sponsor ID
- VIHINJECT / CHUO-2024-15
- Conditions
- HIV I Infection, Injection Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 24 Sep 2026 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 24
- 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.
| Arm | Type | Receives |
|---|---|---|
| DCBA (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| CDBA (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| DBCA (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| BDCA (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| CBDA (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| BCDA (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| DCAB (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| CDAB (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| DACB (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| ADCB (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| CADB (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| ACDB (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| DBAC (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| BDAC (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| DABC (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| ADBC (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| BADC (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| ABDC (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| CBAD (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| BCAD (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| CABD (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| ACBD (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| BACD (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
| ABCD (specific order of procedures with type of injection site and/or use virtual reality headset) | Experimental | Procedure: Dorsogluteal intramuscular injectionA: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorsogluteal intramuscular injectionAlso: Ventrogluteal intramuscular injection, Dorsogluteal intramuscular injection with virtual reality headset, Ventro-gluteal intramuscular injection with virtual reality headsetThe 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 | Procedure or surgery | ABCD (specific order of procedures with type of injection site and/or use virtual reality headset), ABDC (specific order of procedures with type of injection site and/or use virtual reality headset), ACBD (specific order of procedures with type of injection site and/or use virtual reality headset), ACDB (specific order of procedures with type of injection site and/or use virtual reality headset), ADBC (specific order of procedures with type of injection site and/or use virtual reality headset), ADCB (specific order of procedures with type of injection site and/or use virtual reality headset), BACD (specific order of procedures with type of injection site and/or use virtual reality headset), BADC (specific order of procedures with type of injection site and/or use virtual reality headset), BCAD (specific order of procedures with type of injection site and/or use virtual reality headset), BCDA (specific order of procedures with type of injection site and/or use virtual reality headset), BDAC (specific order of procedures with type of injection site and/or use virtual reality headset), BDCA (specific order of procedures with type of injection site and/or use virtual reality headset), CABD (specific order of procedures with type of injection site and/or use virtual reality headset), CADB (specific order of procedures with type of injection site and/or use virtual reality headset), CBAD (specific order of procedures with type of injection site and/or use virtual reality headset), CBDA (specific order of procedures with type of injection site and/or use virtual reality headset), CDAB (specific order of procedures with type of injection site and/or use virtual reality headset), CDBA (specific order of procedures with type of injection site and/or use virtual reality headset), DABC (specific order of procedures with type of injection site and/or use virtual reality headset), DACB (specific order of procedures with type of injection site and/or use virtual reality headset), DBAC (specific order of procedures with type of injection site and/or use virtual reality headset), DBCA (specific order of procedures with type of injection site and/or use virtual reality headset), DCAB (specific order of procedures with type of injection site and/or use virtual reality headset), DCBA (specific order of procedures with type of injection site and/or use virtual reality headset) |
Primary outcome
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.
Time frame: 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).
8 secondary outcomes
Detect the influence of sex on the perception of pain induced by antiretroviral injection.
Time frame: 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)
Detect the influence of age on the perception of pain induced by antiretroviral injection.
Time frame: 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)
Detect the influence of BMI on the perception of pain induced by antiretroviral injection.
Time frame: 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)
Detect the influence of number of injections on the perception of pain induced by antiretroviral injection.
Time frame: 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 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
Time frame: 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, particularly in terms of gender and ethnic origins, in order to identify indication biases
Time frame: 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 satisfaction of the professionals who will perform the injections with a questionnaire
Time frame: at the last visit for each patient (at 7-8 months after inclusion)
Evaluate patient satisfaction about injection procedures with questionnaire
Time frame: at the last visit for each patient (at 7-8 months after inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Results publication: PubMed 38985445Jonsson-Oldenbuttel C, Ghosn J, van der Valk M, Florence E, Vera F, De Wit S, Rami A, Bonnet F, Hocqueloux L, Hove K, Ait-Khaled M, DeMoor R, Bontempo G, Latham CL, Gutner CA, Iyer S, Gill M, Czarnogorski M, D'Amico R, van Wyk J. Safety and Effectiveness From the Cabotegravir and Rilpivirine Implementation Study in European Locations Study: Phase 3b Hybrid Type III Implementation Study Integrating Cabotegravir + Rilpivirine Long-Acting Into European Clinical Settings. J Acquir Immune Defic Syndr. 2024 Aug 15;96(5):472-480. doi: 10.1097/QAI.0000000000003448. Epub 2024 Jul 9.
- Results publication: PubMed 28273627Larkin TA, Ashcroft E, Elgellaie A, Hickey BA. Ventrogluteal versus dorsogluteal site selection: A cross-sectional study of muscle and subcutaneous fat thicknesses and an algorithm incorporating demographic and anthropometric data to predict injection outcome. Int J Nurs Stud. 2017 Jun;71:1-7. doi: 10.1016/j.ijnurstu.2017.02.017. Epub 2017 Feb 22.
- Results publication: PubMed 36330583Gao Y, Xu Y, Liu N, Fan L. Effectiveness of virtual reality intervention on reducing the pain, anxiety and fear of needle-related procedures in paediatric patients: A systematic review and meta-analysis. J Adv Nurs. 2023 Jan;79(1):15-30. doi: 10.1111/jan.15473. Epub 2022 Nov 3.
- Results publication: PubMed 32720308Chuan A, Zhou JJ, Hou RM, Stevens CJ, Bogdanovych A. Virtual reality for acute and chronic pain management in adult patients: a narrative review. Anaesthesia. 2021 May;76(5):695-704. doi: 10.1111/anae.15202. Epub 2020 Jul 27.
- Results publication: PubMed 37452553Roldan-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.
- Results publication: PubMed 28618093Larkin TA, Ashcroft E, Hickey BA, Elgellaie A. Influence of gender, BMI and body shape on theoretical injection outcome at the ventrogluteal and dorsogluteal sites. J Clin Nurs. 2018 Jan;27(1-2):e242-e250. doi: 10.1111/jocn.13923. Epub 2017 Nov 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniela PIRES ROTEIA principal investigator
CHU Orléans
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorsogluteal intramuscular injection in people with HIV I Infection and Injection Pain, run by Centre Hospitalier Régional d'Orléans at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela PIRES ROTEIA (02 38 65 13 38 ext. +33, daniela.pires-roteia@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06834113, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.