Comparing pain from HIV injections using different sites and virtual reality

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: daniela.pires-roteia@chu-orleans.fr
• Phone: 02 38 65 13 38

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.