Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 29, 2024
Date Accepted: Feb 7, 2024
Patient Education and Decision Support for Long-acting Injectable HIV Antiretroviral Therapy: Protocol for Tool Development and Pilot Testing in New York Ryan White HIV/AIDS Program Medical Case Management Programs
ABSTRACT
Background:
Long-acting injectable (LAI) HIV antiretroviral therapy (ART) presents a major opportunity to facilitate and sustain HIV viral suppression, thus improving health and survival among people with HIV (PWH) and reducing the risk of onward transmission. However, realizing the public health potential of LAI ART requires reaching patients who face barriers to daily oral ART adherence. Ryan White HIV/AIDS Program Part A medical case management programs provide an array of services to address barriers to HIV care and treatment among low-income PWH. These programs are effective at improving engagement along the continuum of care, but findings of limited program impact on durable viral suppression highlight the need to further innovate and hone strategies to support long-term ART adherence.
Objective:
This study aims to adapt and expand Ryan White medical case management service strategies to promote LAI ART awareness, access, patient-centered decision-making, and adherence, with the larger goal of improving health outcomes in the populations that could most benefit from alternatives to daily oral ART regimens.
Methods:
Based on findings from patient and provider focus groups and discrete choice experiments, as well as feedback from advisory board meetings, our team developed patient education materials and a patient-provider decision tool to pilot at six partnering medical case management programs. Implementation outcomes, measured through provider interviews, surveys, and service reporting, will guide the further specification of strategies to integrate LAI ART options into medical case management program implementation.
Results:
The study was funded in late April 2021 and received IRB approval in May 2021 under Protocol 20-096. Focus groups were conducted in late 2021 (N=21), discrete choice experiments ran from June 2022 to January 2023 (N=378), and tools for piloting were developed by May 2023. The trial (May 2023 through January 2024), has enrolled over 200 patients.
Conclusions:
Conclusions:
This study will produce evidence regarding the acceptability, feasibility, appropriateness, and effectiveness of a package of patient-oriented tools for comparing LAI ART and daily oral ART options. Study strengths include formative work to guide tool development, a mixed-methods design, and the testing of tools in real-world safety-net service settings. Clinical Trial: ClinicalTrials.gov NCT05833542; https://clinicaltrials.gov/study/NCT05833542
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