Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-01-07 @ 7:02 AM
Study NCT ID:
NCT06468995
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antiviral Long Acting Drugs Landing in People Living With HIV
Sponsor:
IRCCS San Raffaele
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALADDIN
Brief 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.
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.
Detailed Description:
This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study. This means that the study will focus both on implementation and effectiveness by examination of two different settings of treatment administration (hospital-based and home-based) to identify what facilitators or barriers may improve feasibility (i.e. factors that can either help or hinder the successful implementation), appropriateness and acceptability of each strategy delivery mode in order to address the needs of PLWH followed in a large clinical center in Milan, Italy.
The study will use an implementation science approach to address the question of 'what works, where and why' by identifying factors and processes that negatively and positively affect implementation outcomes from both the patients and providers perspective.
Real-world efforts to delivering the treatment to HIV-1-infected, virologically suppressed adults in two different settings (home or hospital) will be sustained.
Two healthcare delivery pathways will be explored in this study:
1. Hospital-based setting: HIV clinic nurse will administer injections at the clinic;
2. Home-patient setting: HIV clinic nurse will administer injections at patient home.
San Raffaele Hospital has participated in the phase III trials of CAB LA + RPV LA and has already developed a large experience in treating patients with LA regimes. LA administration in out-of-hospital sites could be a safe and viable option to satisfy patient needs in terms of time to move to the hospital.
Enrolled participants will be randomized, in a ratio 1:1, to the following arms:
1. drug treatment and follow-up in hospital (hospital arm);
2. drug treatment and follow-up at home (home arm).
HCPs will also be study participants. Their insight regarding feasibility, acceptability, and appropriateness of CAB LA + RPV LA administration overall and in a home-based or a hospital-based setting will be evaluated during the study period.
Cabotegravir long-acting + rilpivirine long-acting (CAB LA + RPV LA) is a licensed new drug, already used in clinical practice, for the treatment of HIV infection.
At the discretion of the person with HIV and the physician, there are two ways to begin the long acting therapy regimen:
* By taking the two drugs cabotegravir and rilpivirine orally for about a month (one tablet each), taken together 1 time a day and on a full stomach, and then switching to injectable (LA) formulations (optional according to clinical practice).
* Directly with injectable formulation.
In this study IM CAB + RPV will be delivered in the hospital-based or the home-based setting. Injections will be delivered by HCPs in the two study settings.
Study participants living with HIV receiving IM CAB + RPV, HCPs will provide their insight on the implementation of LA IM CAB+RPV by means of questionnaires and scales over the study period.
Study participants living with HIV receiving IM CAB + RPV will be asked to complete 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).
HCPs will be asked to complete the Feasibility of Implementation Measure (FIM), the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM) and a Likert scale.
Study participants receiving drug treatment will be treated in the home-based or hospital-based study setting for 12 \[1 month for screening + 11 of hospital or home treatment administration, in accordance to the clinical practice. People receiving optional OLI according to clinical practice will receive oral antiretrovirals in the month before baseline. HCPs are responsible for the administration of LA IM CAB + RPV in the two study settings.
People receiving LA IM CAB + RPV in the hospital setting will receive injections as per medical practice in dedicated spaces within the Infectious Diseases Unit of San Raffaele Hospital.
People receiving LA IM CAB + RPV in the home-based setting will receive injections at their home within the Metropolitan Area of Milan. HCPs will directly reach the study participant's home. Administration of CAB + RPV, completion of study surveys, blood collection for laboratory exams according to clinical practice and all study procedures will be performed by the HCPs at the study participant home.
The study will use an implementation science approach to address the question of 'what works, where and why' by identifying factors and processes that negatively and positively affect implementation outcomes from both the patients and providers perspective.
Real-world efforts to delivering the treatment to HIV-1-infected, virologically suppressed adults in two different settings (home or hospital) will be sustained.
Two healthcare delivery pathways will be explored in this study:
1. Hospital-based setting: HIV clinic nurse will administer injections at the clinic;
2. Home-patient setting: HIV clinic nurse will administer injections at patient home.
San Raffaele Hospital has participated in the phase III trials of CAB LA + RPV LA and has already developed a large experience in treating patients with LA regimes. LA administration in out-of-hospital sites could be a safe and viable option to satisfy patient needs in terms of time to move to the hospital.
Enrolled participants will be randomized, in a ratio 1:1, to the following arms:
1. drug treatment and follow-up in hospital (hospital arm);
2. drug treatment and follow-up at home (home arm).
HCPs will also be study participants. Their insight regarding feasibility, acceptability, and appropriateness of CAB LA + RPV LA administration overall and in a home-based or a hospital-based setting will be evaluated during the study period.
Cabotegravir long-acting + rilpivirine long-acting (CAB LA + RPV LA) is a licensed new drug, already used in clinical practice, for the treatment of HIV infection.
At the discretion of the person with HIV and the physician, there are two ways to begin the long acting therapy regimen:
* By taking the two drugs cabotegravir and rilpivirine orally for about a month (one tablet each), taken together 1 time a day and on a full stomach, and then switching to injectable (LA) formulations (optional according to clinical practice).
* Directly with injectable formulation.
In this study IM CAB + RPV will be delivered in the hospital-based or the home-based setting. Injections will be delivered by HCPs in the two study settings.
Study participants living with HIV receiving IM CAB + RPV, HCPs will provide their insight on the implementation of LA IM CAB+RPV by means of questionnaires and scales over the study period.
Study participants living with HIV receiving IM CAB + RPV will be asked to complete 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).
HCPs will be asked to complete the Feasibility of Implementation Measure (FIM), the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM) and a Likert scale.
Study participants receiving drug treatment will be treated in the home-based or hospital-based study setting for 12 \[1 month for screening + 11 of hospital or home treatment administration, in accordance to the clinical practice. People receiving optional OLI according to clinical practice will receive oral antiretrovirals in the month before baseline. HCPs are responsible for the administration of LA IM CAB + RPV in the two study settings.
People receiving LA IM CAB + RPV in the hospital setting will receive injections as per medical practice in dedicated spaces within the Infectious Diseases Unit of San Raffaele Hospital.
People receiving LA IM CAB + RPV in the home-based setting will receive injections at their home within the Metropolitan Area of Milan. HCPs will directly reach the study participant's home. Administration of CAB + RPV, completion of study surveys, blood collection for laboratory exams according to clinical practice and all study procedures will be performed by the HCPs at the study participant home.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: