Comparing pain from HIV injections using different sites and virtual reality

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 study is testing whether using virtual reality during HIV injections can help reduce pain for patients receiving antiretroviral treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Régional d'Orléans (Academic / other)
• Locations: 5 sites (Orléans, Loiret and 4 other locations)
• Trial ID: NCT06834113 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, open-label study aims to evaluate the pain intensity experienced by HIV-1 patients receiving injectable antiretroviral treatments, specifically Cabotegravir® and Rilpivirine®. Participants will undergo four different injection procedures: dorsogluteal and ventrogluteal injections, with and without the use of a virtual reality headset. Each patient will serve as their own control, experiencing all injection methods in a randomized order. Pain assessments will be conducted using a numerical scale following each injection, and follow-up visits will monitor pain and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are HIV-1 infected patients aged 18 and older who are virologically controlled and scheduled to receive Cabotegravir and Rilpivirine.

Not a fit: Patients on other injectable antiretroviral treatments or those with conditions that prevent the use of a virtual reality headset may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for patients receiving injectable antiretroviral treatments.

How similar studies have performed: While there is limited data on this specific approach, similar studies exploring pain management in injectable treatments have shown promising results.

Eligibility criteria

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.

Where this trial is running

Orléans, Loiret and 4 other locations

• Center Hospitalier Universitaire d'Orléans — Orléans, Loiret, France (Recruiting)
• CHD Vendée — La Roche-sur-Yon, France (Recruiting)
• CH Chartres — Le Coudray, France (Recruiting)
• CHU Nantes — Nantes, France (Recruiting)
• CHU Poitiers — Poitiers, France (Recruiting)

Study contacts

• Principal investigator: Daniela PIRES ROTEIA — CHU Orléans
• Study coordinator: Daniela PIRES ROTEIA

Conditions HIV I Infection; Injection Pain