Ignite Creation Date:
2024-07-17 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-12
Brief Title:
Antiviral Long Acting Drugs Landing in People Living With HIV
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 ie 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 11 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 CABRPV 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 HIVAIDS-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 participants 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 11 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 CABRPV 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 HIVAIDS-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 participants 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:
None
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?:
None