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

NCT06834113 | Recruiting

• 1 other identifier: CHUO-2024-15
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

HIV I Infection; Injection Pain

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  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.

  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.

  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.

  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

  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)

Study Arms (24)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Procedure: Dorsogluteal intramuscular injection

Interventions

Dorsogluteal intramuscular injection PROCEDURE

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

Also known as: Ventrogluteal intramuscular injection, Dorsogluteal intramuscular injection with virtual reality headset, Ventro-gluteal intramuscular injection with virtual reality headset

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (5)

Center Hospitalier Universitaire d'Orléans

Orléans, Loiret, 45067, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, 85925, France

RECRUITING

CH Chartres

Le Coudray, 28630, France

RECRUITING

CHU Nantes

Nantes, 44093, France

RECRUITING

CHU Poitiers

Poitiers, 90577, France

RECRUITING

Related Publications (6)

• 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.

  PMID: 38985445 RESULT

• Larkin 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.

  PMID: 28273627 RESULT

• Gao 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.

  PMID: 36330583 RESULT

• Chuan 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.

  PMID: 32720308 RESULT

• 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.

  PMID: 37452553 RESULT

• Larkin 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.

  PMID: 28618093 RESULT

Study Officials

• Daniela PIRES ROTEIA

  CHU Orléans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela PIRES ROTEIA

CONTACT

02 38 65 13 38; daniela.pires-roteia@chu-orleans.fr

Fanny LOUAT

CONTACT

02 38 74 42 95; fanny.louat@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Non applicable
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 19, 2025
• Study Start: January 24, 2025
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): September 24, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

FR (5)