The trials of insurance-based Data to Care-Rx: Low enrollment in the Antiretroviral Improvement among Medicaid enrolleeS (AIMS) study.

BACKGROUND Approaches to strengthen Data-to-Care (D2C) models are needed. We tested an insurance-based D2C prescription model (D2C-Rx), which used antiretroviral therapy (ART) prescription claims to identify people with HIV who fail to fill ART prescriptions in a timely manner and to provide ART adherence support. The Antiretroviral Improvement among Medicaid EnrolleeS (AIMS) study was the first trial of an insurance-based D2C-Rx program. We describe AIMS study enrollment, focusing on patient-participants in the AIMS program arm.

SETTING Virginia, USA.

METHODS AIMS used Virginia Medicaid claims and HIV surveillance data to identify Medicaid enrollees with HIV who were without an ART prescription and their providers; study staff then provided targeted adherence support. The target patient-participant sample size was 1,000. The outcome of interest was HIV viral suppression.

RESULTS The study encountered difficulty recruiting patient-participants. Low enrollment prompted major changes to the protocol, including revisions to study design, eligibility criteria, and recruitment methods. These changes were unsuccessful. The trial was terminated due to low patient-participant enrollment (n=4).

CONCLUSION Reasons for low patient-participant enrollment may include phone-based recruitment approach; lengthy identity verification and consent procedures; and lack of participant compensation. While we aimed to identify people with HIV without a current ART prescription refill, several participants reported having their medications available; this discrepancy suggests issues with unexpected participant behavior (e.g., stockpiling) or timeliness and accuracy of prescription claims data. Future insurance-based D2C-Rx interventions should account for these challenges, be tailored to context, and be nimble enough to pivot to alternative recruitment methods when needed.