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

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-05-18 DOI:10.1016/j.cct.2025.107959

April D. Kimmel , Kathy K. Byrd , Michael Stirratt , Delton Harris , Rachel Stallings , Rose S. Bono , Andrew Mitchell , Rebecca Dillingham , Caressa Palmer , Elliot Popoff , Zhongzhe Pan , Karen Ingersoll , Bassam Dahman , AIMS study team

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引用次数: 0

Abstract

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).

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医疗补助计划（AIMS）患者抗逆转录病毒改善研究方案：一项利用实时行政索赔支持抗逆转录病毒处方依从性的集群随机对照试验。

在美国，坚持护理和抗逆转录病毒治疗（ART）的依从性是艾滋病毒治疗的主要临床和公共卫生挑战。传统的数据到护理（D2C）方法利用卫生部门的监测数据来促进艾滋病毒护理的保留，但在数据的及时性和不确定的调查结果方面存在挑战。更早地识别有丧失治疗风险的艾滋病毒感染者，例如当抗逆转录病毒治疗处方未按处方开具时，代表了D2C （D2C- rx或基于处方的D2C）的新方向。方法：我们设计了医疗补助计划（Medicaid）在校生的抗逆转录病毒改善（AIMS）研究，这是弗吉尼亚州的一项d2d - rx计划，该研究利用了弗吉尼亚州医疗补助计划的实时行政索赔和弗吉尼亚州卫生部的艾滋病毒监测数据（2023年4月至2024年6月）。AIMS是一项全州范围的集群随机对照试验，比较了弗吉尼亚州医疗补助计划中没有当前ART处方的参保者的分阶段、多层次支持（干预）计划与常规护理。支持包括为先前没有ART处方的患者提供的提供者级组件和为那些延迟 > 30-90天重新填写ART处方的患者提供的患者级组件。我们假设与常规治疗相比，AIMS可以在12 个月时增强HIV病毒抑制并改善ART依从性。我们描述了最初的研究方案，并讨论了研究设计和计划实施的变化。我们还考虑了关键的方法学贡献，以及患者和提供者水平登记的限制和挑战，例如ART处方数据的准确性。伦理与传播：本研究经弗吉尼亚联邦大学机构审查委员会（HM20018229）审查并批准。注册：该试验在clinicaltrials.gov上注册（NCT05477485）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.