Innovative administration of long-acting injectables for HIV treatment enhancement at home (INVITE-HOME): implementation science study protocol

IntroductionThere is high interest in long-acting injectable antiretroviral therapy (LAI-ART) among people with HIV (PWH), with many conveniences for uptake and persistence. However, both patients and clinicians have expressed important barriers to effective implementation, including concerns about...

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Vydáno v:BMJ open Ročník 15; číslo 8; s. e097921
Hlavní autoři: Bourdeau, Beth, Rebchook, Greg, Shade, Starley B, O’Shea, Jesse, Buchacz, Kate, Harris, Orlando, Johnson, Mallory O, Palomares, Michelle, Bolton, Alicia T, Van Nuys, Jonathan, Moore, Erin, Saberi, Parya
Médium: Journal Article
Jazyk:angličtina
Vydáno: England British Medical Journal Publishing Group 05.08.2025
BMJ Publishing Group LTD
BMJ Publishing Group
Témata:
Acquired immune deficiency syndrome
Administration
AIDS
Anti-HIV Agents - administration & dosage
Antiretroviral drugs
Clinics
Curricula
Delayed-Action Preparations - administration & dosage
Drug therapy
Effectiveness studies
Feasibility Studies
Feedback
Health Services
HIV
HIV & AIDS
HIV Infections - drug therapy
Home Care Services
Human immunodeficiency virus
Humans
Implementation Science
Injections
Intervention
Interviews
Medication Adherence
Partnering
Patients
Primary care
Protocol
Public health
Regulatory approval
United States > US
San Francisco California
Administration
Health Services
Implementation Science
HIV & AIDS
Feasibility Studies
ISSN:2044-6055, 2044-6055
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Popis
Shrnutí:IntroductionThere is high interest in long-acting injectable antiretroviral therapy (LAI-ART) among people with HIV (PWH), with many conveniences for uptake and persistence. However, both patients and clinicians have expressed important barriers to effective implementation, including concerns about frequent clinic visits and strain on 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-identified and clinician-identified barriers. Alternative LAI-ART delivery methods have the potential to increase the PWH and layperson injector’s confidence, empowerment, convenience, privacy and self-management skills and ultimately facilitate LAI-ART uptake and persistence.Methods and analysisINVITE-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. First, INVITE-Home will design and develop an innovative, theory-based layperson injector training to improve acceptability and uptake of LAI-ART in home-based settings, grounded in qualitative evaluation of training barriers and needs of PWH, layperson injectors and clinicians to develop the training. In Aim 2, INVITE-Home will enhance understanding of home-based LAI-ART using the training, by examining implementation and effectiveness of home-based LAI-ART injections.Ethics and disseminationThis study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board and the scientific staff of HIV Research Branch, Division of HIV Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, at the Centers for Disease Control and Prevention. Study staff will disseminate findings locally (eg, to partnering clinics, via the UCSF Center for AIDS Prevention Studies’ Community Engagement Core), statewide (eg, the California Department of Public Health’s Office of AIDS) and nationally at conferences related to HIV.Trial registration numberNCT06488846.
Bibliografie:Protocol
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Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
None declared.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2024-097921