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ACTIVE NOT RECRUITING
NCT06468995
NA

Antiviral Long Acting Drugs Landing in People Living With HIV

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

Summary

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.

Official title: Antiviral Long Acting Drugs Landing in People Living With HIV (ALADDIN): Prospective, Double-arm, Randomized, Open-label, Implementation-effectiveness Hybrid Type III Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-12-02

Completion Date

2026-07-01

Last Updated

2026-03-10

Healthy Volunteers

Yes

Interventions

OTHER

Surveys completion

Completion of surveys: the Feasibility of Implementation Measure (FIM), the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM), a Likert scale, the EQ-5D-5L questionnaire, the HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire and the HIV Treatment Satisfaction Questionnaire (HIVTSQ).

DRUG

Home administration of CAB+RPV

Drug treatment and follow-up at home (home arm).

DRUG

Hospital administration of CAB+RPV

Drug treatment and follow-up in hospital (hospital arm)

Locations (1)

IRCCS San Raffaele Scientific Institute

Milan, Italy