Antiviral Long Acting Drugs Landing in People Living With HIV
NCT Number: NCT06468995
Acronym: ALADDIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: HIV|Antiviral Agents
Interventions: OTHER: Surveys completion|DRUG: Home administration of CAB+RPV|DRUG: Hospital administration of CAB+RPV
Sponsor: IRCCS San Raffaele
Collaborators: GlaxoSmithKline
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-11-01
Locations: IRCCS San Raffaele Scientific Institute, Milan, 20127, Italy

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.

Primary Outcome Measures: Feasibility of Implementation Measure (FIM) scale, Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Feasibility of Implementation Measure (FIM) and average composite score., Months 1 and 7 and 11|Acceptability of Intervention Measure (AIM) scale, Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Acceptability of Intervention Measure (AIM) and average composite score., Months 1 and 7 and 11|Intervention Appropriateness Measure (IAM) scale, Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Intervention Appropriateness Measure (IAM) and average composite score., Months 1 and 7 and 11|Qualitative insights, Qualitative insights regarding feasibility, acceptability, and appropriateness of CAB+RPV IM q2M., Months 1 and 7 and 11
Secondary Outcome Measures: Proportion of patients willing to enroll in the study, Proportion of patients willing to enroll in the study out of total screened to assess the uptake, and fidelity of CAB LA + RPV LA administration overall and in a home-based or hospital-based setting., Months 7 and 11|Proportion of patients voluntary asking to stop CAB+RPV LA administration, Proportion of patients voluntary asking to stop CAB+RPV LA administration out of total enrolled in the study to assess the uptake, and fidelity of CAB LA + RPV LA administration overall and in a home-based or hospital-based settingy, Months 7 and 11|Proportion of CAB+RPV LA injections occurring within the target window, Proportion of CAB+RPV IM injections occurring within the target window from target date (+/- 7 days of target date) to assess the uptake, and fidelity of CAB LA + RPV LA administration overall and in a home-based or hospital-based setting, Months 7 and 11|Average score of satisfaction on a Likert scale, Average score of satisfaction on a Likert scale for each implementation strategy used and qualitative insights into the relative value of the strategies and any adaptations informed by Consolidated Framework for Implementation Research Constructs (CFIR) to assess the satisfaction with the implementation strategies adopted, including unanticipated adaptations, facilitators and barriers to the uptake and process of CAB LA + RPV LA from the perspectives of patients, overall and in a home-based or hospital-based setting, Months 7 and 11|Proportion of PWH with HIV-RNA >50 copies/mL, Proportion of people with confirmed HIV-RNA \>50 copies/mL to monitor safety and effectiveness of CAB LA + RPV LA administration overall and in a home-based and hospital-based setting, as per clinical practice., Months 7 and 11|Time (months) to LA discontinuation, Time (months) to CAB+RPV LA discontinuation from enrollment to monitor safety and effectiveness of CAB LA + RPV LA administration overall and in a home-based and hospital-based setting, as per clinical practice, Months 7 and 11|Adverse Events and Serious AEs, Proportion of people with Adverse Events and Serious AEs to monitor safety and effectiveness of CAB LA + RPV LA administration overall and in a home-based and hospital-based setting, as per clinical practice, Months 7 and 11|EQ-5D-5L questionnaire, Average change vs baseline on the utility value derived from EQ-5D-5L questionnaire, Months 1 and 7 and 11|HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire, Average change vs baseline on the utility value derived from the nine domains scores derived from the HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire, Months 1 and 7 and 11|HIV Treatment Satisfaction Questionnaire (HIVTSQ), Average change vs baseline on the utility value derived from the nine domains scores derived from the HIV Treatment Satisfaction Questionnaire (HIVTSQ), Months 1 and 7 and 11