Home
Clinical Trials
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

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-24

Study Completion Date

2026-09-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

HIV I Infection Injection Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Non applicable

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DCBA (specific order of procedures with type of injection site and/or use virtual reality headset)

A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type 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

CDBA (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

DBCA (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

BDCA (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

CBDA (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

BCDA (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

DCAB (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

CDAB (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

DACB (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

ADCB (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

CADB (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

ACDB (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

DBAC (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

BDAC (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

DABC (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

ADBC (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

BADC (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

ABDC (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

CBAD (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

BCAD (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

CABD (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

ACBD (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

BACD (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

ABCD (specific order of procedures with type of injection site and/or use virtual reality headset)

Group Type EXPERIMENTAL

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dorsogluteal intramuscular injection

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ventrogluteal intramuscular injection Dorsogluteal intramuscular injection with virtual reality headset Ventro-gluteal intramuscular injection with virtual reality headset

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniela PIRES ROTEIA

Role: PRINCIPAL_INVESTIGATOR

CHU Orléans

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center Hospitalier Universitaire d'Orléans

Orléans, Loiret, France

Site Status RECRUITING

CHD Vendée

La Roche-sur-Yon, , France

Site Status RECRUITING

CH Chartres

Le Coudray, , France

Site Status RECRUITING

CHU Nantes

Nantes, , France

Site Status RECRUITING

CHU Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Daniela PIRES ROTEIA

Role: CONTACT

Phone: 02 38 65 13 38

Email: [email protected]

Fanny LOUAT

Role: CONTACT

Phone: 02 38 74 42 95

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Daniela PIRES ROTEIA

Role: primary

Dominique MERRIEN, Dr

Role: primary

Iuliana DARASTEANU, Dr

Role: primary

Clotilde ALLAVENA, Dr

Role: primary

Gwenaël LE MOAL, Dr

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT

PMID: 38985445 (View on PubMed)

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.

Reference Type RESULT

PMID: 28273627 (View on PubMed)

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.

Reference Type RESULT

PMID: 36330583 (View on PubMed)

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.

Reference Type RESULT

PMID: 32720308 (View on PubMed)

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.

Reference Type RESULT

PMID: 37452553 (View on PubMed)

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.

Reference Type RESULT

PMID: 28618093 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHUO-2024-15

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

DCBA (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

CDBA (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

DBCA (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

BDCA (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

CBDA (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

BCDA (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

DCAB (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

CDAB (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

DACB (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

ADCB (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

CADB (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

ACDB (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

DBAC (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

BDAC (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

DABC (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

ADBC (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

BADC (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

ABDC (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

CBAD (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

BCAD (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

CABD (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

ACBD (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

BACD (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

ABCD (specific order of procedures with type of injection site and/or use virtual reality headset)

Dorsogluteal intramuscular injection

Interventions

Dorsogluteal intramuscular injection

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Centre Hospitalier Régional d'Orléans

Responsible Party

Principal Investigators

Daniela PIRES ROTEIA

Locations

Center Hospitalier Universitaire d'Orléans

CHD Vendée

CH Chartres

CHU Nantes

CHU Poitiers

Countries

Central Contacts

Daniela PIRES ROTEIA

Fanny LOUAT

Facility Contacts

Daniela PIRES ROTEIA

Dominique MERRIEN, Dr