Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488846
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-17
Brief Title:
Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home
Status:
RECRUITING
Status Verified Date:
2024-10
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:
INVITE-Home
Brief Summary:
This study will support the expansion of long-acting injectable antiretroviral therapy LAI-ART in non-clinical settings by developing implementing and evaluating a comprehensive theory-informed training intervention to support the administration of LAI-ART by a trained layperson injector eg friend family partner identified by a person living with HIV This study will address barriers to LAI-ART uptake and persistence enhance real-world effectiveness and help close critical HIV care gaps
Detailed Description:
There is high interest in long-acting injectable antiretroviral therapy LAI-ART among people with PWH with many conveniences for uptake and persistence While LAI-ART eliminate the need for daily pill-taking and have the potential to help close critical gaps in HIV care patients have expressed important barriers to effective implementation and concerns that frequent clinic visits can exacerbate stigma increase the risk of unwanted disclosure and lead to frequent disruptions in their daily lives The need to travel to a clinic for injection visits multiple times throughout the year can also be financially and logistically prohibitive for many patients and can widen existing healthcare disparities Similarly clinicians worry that additional visits outside of routine care may lead to missed appointments decreased engagement in care and put further strain on limited clinic resources Administration of LAI-ART by a trained layperson injector such as family friend or partner of the patient can help mitigate some of these patient- and clinician-identified barriers This model of care has been used successfully in other contexts but up to now it has not been evaluated for HIV treatment Alternative LAI-ART delivery methods have the potential to increase the PWH and layperson injectors confidence empowerment convenience privacy and self-management skills and ultimately facilitate LAI-ART uptake and persistence INVITE-Home Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home will support the expansion of LAI-ART in non-clinical settings by developing implementing and evaluating a comprehensive theory-informed training to support the administration of LAI-ART by a trained layperson injector In Aim 1 the investigators will design and develop an innovative theory-based layperson injector training to improve acceptability and uptake of LAI-ART in home-based settings Investigators will qualitatively evaluate training barriers and needs of PWH layperson injectors and clinicians to develop the training In Aim 2 investigators will enhance understanding of home-based LAI-ART using the training developed in Phase 1 by examining implementation and effectiveness of home-based LAI-ART injections This study will address a critical need to develop alternative and decentralized LAI-ART delivery methods that can mitigate barriers to uptake and persistence enhance the real-world LAI-ART effectiveness reduce systemic and structural inequities address clinical and policy challenges and close key gaps in HIV care
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?:
None
Is an FDA AA801 Violation?:
None