医疗补助参保者抗逆转录病毒治疗改善研究方案（AIMS）：一项利用实时行政索赔支持抗逆转录病毒处方依从性的整群随机对照试验
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.
作者信息
Kimmel April D, Byrd Kathy K, Stirratt Michael, Harris Delton, Stallings Rachel, Bono Rose S, Mitchell Andrew, Dillingham Rebecca, Palmer Caressa, Popoff Elliot, Pan Zhongzhe, Ingersoll Karen, Dahman Bassam
机构信息
Department of Health Policy, School of Public Health, Virginia Commonwealth University, Richmond, VA, United States of America; Division of Infectious Diseases, Department of Internal Medicine, School of Medicine, Virginia Commonwealth University, Richmond, VA, United States of America.
HIV Research Branch, Division of HIV Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States of America.
出版信息
Contemp Clin Trials. 2025 Jul;154:107959. doi: 10.1016/j.cct.2025.107959. Epub 2025 May 18.
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).
引言
在美国，坚持接受治疗和抗逆转录病毒疗法（ART）的依从性是艾滋病毒治疗中的主要临床和公共卫生挑战。传统的数据到关怀（D2C）方法利用卫生部门的监测数据来促进艾滋病毒感染者坚持接受治疗，但存在数据及时性和结果不确定的问题。更早识别有失去治疗风险的艾滋病毒感染者，例如当抗逆转录病毒药物处方未被取药时，代表了D2C的一个新方向（D2C-Rx或基于处方的D2C）。
方法
我们设计了医疗补助参保者抗逆转录病毒改善（AIMS）研究，这是弗吉尼亚州的一项基于处方的D2C倡议，利用了弗吉尼亚医疗补助的实时行政索赔数据和弗吉尼亚卫生部的艾滋病毒监测数据（2023年4月至2叭4年6月）。AIMS是一项全州范围的整群随机对照试验，比较了一个分阶段、多层次的支持项目（干预措施）与常规治疗，对象为当前没有抗逆转录病毒药物处方的弗吉尼亚医疗补助参保者。支持措施包括为那些没有既往抗逆转录病毒药物处方的人提供提供者层面的组成部分，以及为那些抗逆转录病毒药物处方续期延迟超过30至90天的人提供患者层面的组成部分。我们假设与常规治疗相比，AIMS将在12个月时提高艾滋病毒病毒抑制率并改善抗逆转录病毒疗法的依从性。我们描述了原始研究方案，并讨论了对研究设计和项目实施所做的更改。我们还考虑了关键的方法学贡献，以及患者和提供者层面登记方面的局限性和挑战，如抗逆转录病毒药物处方数据的准确性。
伦理与传播
本研究经弗吉尼亚联邦大学机构审查委员会审查并批准（HM20018229）。
注册
该试验已在clinicaltrials.gov上注册（NCT05477485）。
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