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 (VIHINJECT)

Centre Hospitalier Régional d'Orléans

Status

Enrolling

Conditions

Injection Pain

HIV I Infection

Treatments

Procedure: Dorsogluteal intramuscular injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06834113

CHUO-2024-15

Details and patient eligibility

About

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.

Full 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

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

120 participants in 24 patient groups

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

Experimental group

Description:

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

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

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

Experimental group

Description:

Treatment:

Procedure: Dorsogluteal intramuscular injection

Trial contacts and locations

Central trial contact

Daniela PIRES ROTEIA; Fanny LOUAT

Data sourced from clinicaltrials.gov

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