Antiviral Long Acting Drugs Landing in People Living With HIV
NCT06468995 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-03-10
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.
Conditions
- HIV
- Antiviral Agents
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)
Sponsors & Collaborators
- collaborator INDUSTRY
-
IRCCS San Raffaele
lead OTHER
Principal Investigators
-
Silvia Nozza, MD · Vita-Salute San Raffaele University
-
Antonella Castagna, Prof · Vita-Salute San Raffaele University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-02
- Primary Completion
- 2026-07-01
- Completion
- 2026-07-01
Countries
- Italy
Study Locations
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