Antiviral Long Acting Drugs Landing in People Living With HIV (ALADDIN): Prospective, Double-arm, Randomized, Open-label, Implementation-effectiveness Hybrid Type III Study
This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for HIV-1-infected patients. Study participants receiving IM CAB + RPV will complete various questionnaires and scales, including FIM, AIM, IAM, EQ-5D-5L, HAT-QoL, and HIVTSQ, throughout the study. HCPs will also complete FIM, AIM, IAM, and a Likert scale.
• People living with HIV-1 infection that could, according to clinical practice, switch current ART to IM CAB + RPV;
• Aged 18 years or older at the time of signing the informed consent.
• People willing to switch to long-acting therapy
• on a stable (≥6 months) antiretroviral regimen and virologically suppressed (HIV-1 RNA \<50 copies/ml):
‣ Documented evidence of plasma HIV-1 RNA measurements \<50 c/mL in the 6 months prior to Screening.
⁃ Plasma HIV-1 RNA \<50 c/mL at Screening.
• Ability to understand informed consent form and other relevant regulatory documents.