Study Protocol(s) for Antiretroviral Improvement among Medicaid EnrolleeS (AIMS): A Cluster-Randomized Controlled Trial Leveraging Real-time Administrative Claims to Support Antiretroviral Prescription Adherence.

INTRODUCTION

Retention in care and antiretroviral therapy (ART) adherence are major clinical and public health challenges in the treatment of HIV in the United States. Traditional data to care (D2C) approaches use health department surveillance data to promote retention in HIV care, with challenges in the timeliness of data and inconclusive findings. Earlier identification of people with HIV who are at risk of loss from care-such as when an ART prescription is not filled-represents a new direction for D2C (D2C-Rx or prescription-based D2C).

METHODS

We designed the Antiretroviral Improvement among Medicaid EnrolleeS (AIMS) study, a D2C-Rx initiative in Virginia, which leveraged real-time administrative claims from Virginia Medicaid and HIV surveillance data from Virginia Department of Health (April 2023-June 2024). AIMS was a statewide cluster-randomized, controlled trial comparing a phased, multi-level program of support (intervention) to usual care, among Virginia Medicaid enrollees without current ART prescriptions. Support included a provider-level component for those with no prior ART prescription and patient-level component for those with a > 30-90-day late ART prescription refill(s). We hypothesized that AIMS would increase HIV viral suppression and improve ART adherence at 12 months compared to usual care. We describe the original study protocol and discuss changes implemented to the study design and program implementation. We also consider key methodologic contributions, as well as limitations and challenges to patient- and provider-level enrollment, such as ART prescription data accuracy.

ETHICS AND DISSEMINATION: This study was reviewed and approved by the Institutional Review Board of Virginia Commonwealth University (HM20018229).

REGISTRATION: The trial is registered at clinicaltrials.gov (NCT05477485).