Intervention to Enhance PrepPersistence Among African American Men Who Have Sex With Men

项目总结 此R01应用程序建议进行一项完全有效的随机对照试验(RCT)来测试 黑人/非裔美国人(B/AA)男男性接触者(MSM)的病人导航干预 准备开始、坚持和保持在护理中。B/AA男男性行为者(MSM)是 不成比例地受到美国艾滋病毒/艾滋病疫情的影响。暴露前预防(PrEP)， 每天服用一次药物，可以极大地降低感染艾滋病毒的风险。然而，社会和结构性障碍 在B/AA MSM中导致PrEP的启动、粘连和保留在护理中处于次优状态。我们的前辈 NIH资助的初步研究(R34MH109371；MPI：Nunn，Chan，Mena)开发并评估了一项干预措施 在PrEP(Ramp-IT-Up)中保留和坚持MSM，这是一个基于优势的简短患者导航计划，以 加强年轻的B/A级MSM的PrEP护理结果。这一干预被发现是高度可接受的 在B/AA型男男性接触者中使用，并显示了初步效果。与对照组参与者相比， 从统计数据看，IT启动参与者更有可能发起PrEP并坚持基于药房的PrEP 填写数据和PrEP血液水平。此外，提升IT的参与者更有可能保留在PrEP中 在3个月和6个月的临床就诊时给予护理。这项研究的具体目标#1将进行全面的 随机对照试验(RCT)评估RAMP-IT-UP在改善PrEP依从性方面的有效性 以及现实世界社区卫生中心(CHCs)中B/AA MSM的护理结果。具体目标2 将评估与标准相比，B/AA级MSM在CHC中提升IT的成本效益 关爱。我们亦会厘定不同程度的导航服务的成本效益，以 根据在具体目标1中收集的数据来预防艾滋病毒。我们的目标是开发一种具有成本效益的干预措施， 改善B/AA男男性接触者的PrEP护理结果并降低HIV发病率，这将与CHCs相关 在美国各地。这项工作的长期目标是降低B/AA男男性接触者中HIV的发病率，这与 联邦政府终止艾滋病毒流行和国家艾滋病毒/艾滋病战略目标。此应用程序由一个 一支经验丰富的调查团队，他们有可靠的记录，在 真实世界的临床环境。

PROJECT SUMMARY This R01 application proposes conducting a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention for Black/African American (B/AA) men who have sex with men (MSM) on PrEP initiation, adherence and retention in care. B/AA men who have sex with men (MSM) are disproportionately impacted by the HIV/AIDS epidemic in the United States. Pre-exposure prophylaxis (PrEP), a once daily medication, can dramatically reduce HIV acquisition risk. However, social and structural barriers have contributed to suboptimal PrEP initiation, adherence, and retention in care among B/AA MSM. Our prior NIH-funded pilot study (R34MH109371; MPI: Nunn, Chan, Mena) developed and evaluated an Intervention to Retain and Adhere MSM in PrEP (RAMP-IT-UP), a brief strengths-based patient navigation program to enhance PrEP care outcomes among young B/AA MSM. The intervention was found to be highly acceptable among B/AA MSM and demonstrated preliminary effectiveness. Compared to control participants, RAMP-IT-UP participants were statistically more likely to initiate PrEP and adhere to PrEP based on pharmacy fill data and PrEP blood levels. Additionally, RAMP-IT-UP participants were more likely to be retained in PrEP care at the 3-month and 6-month clinical visits. Specific Aim #1 of this study will conduct a fully powered randomized controlled trial (RCT to estimate the effectiveness of RAMP-IT-UP in improving PrEP adherence and care outcomes among B/AA MSM in real-world community health center settings (CHCs). Specific Aim #2 will estimate the cost-effectiveness of RAMP-IT-UP among B/AA MSM attending CHCs compared to standard of care. We will also determine the cost-effectiveness of differing levels of intensity of navigation services to prevent HIV based on data collected in Specific Aim #1. Our goal is to develop a cost-effective intervention that enhances PrEP care outcomes and reduces HIV incidence for B/AA MSM which will be relevant for CHCs across the US. The long-term goal of this work is to decrease HIV incidence among B/AA MSM, which aligns with federal Ending the HIV Epidemic and National HIV/AIDS Strategy goals. This application is led by an experienced team of investigators with a proven track record conducting HIV, PrEP and disparities research in real-world clinical settings.