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

项目摘要 本R 01申请建议进行一项完全有效的随机对照试验（RCT），以测试 一项针对黑人/非洲裔美国人（B/AA）男性同性性行为者（MSM）的患者导航干预， PrEP启动，坚持和保留护理。与男性发生性关系的B/AA男性（MSM）是 在美国，艾滋病毒/艾滋病流行病的影响不成比例。暴露前预防（PrEP）， 每天一次的药物治疗，可以大大降低艾滋病毒感染的风险。然而，社会和结构性障碍 导致了B/AA MSM的PrEP启动、依从性和保留护理效果不佳。我们事先 NIH资助的试点研究（R34 MH 109371; MPI：纳恩，陈，梅纳）开发并评价了一种干预措施， 在PrEP中保留和坚持MSM（RAMP-IT-UP），这是一个简短的基于力量的患者导航计划， 加强年轻B/AA MSM中的PrEP护理结果。干预被认为是高度可接受的 在B/AA型MSM人群中进行了初步疗效观察。与对照组相比， RAMP-IT-UP参与者在统计学上更有可能启动PrEP并坚持基于药房的PrEP 填写数据和PrEP血液水平。此外，RAMP-IT-UP参与者更有可能保留在PrEP中 3个月和6个月临床访视时的护理。本研究的具体目标#1将进行一项全功率 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 在现实世界的社区卫生中心设置（CHCs）中，B/AA MSM之间的护理结果。具体目标#2 我会评估B/AA MSM参加社区卫生中心的RAMP-IT-UP与标准的成本效益 照顾。我们还将确定不同强度的导航服务的成本效益， 根据具体目标#1中收集的数据预防艾滋病毒。我们的目标是开发一种具有成本效益的干预措施， 增强PrEP护理结果并降低B/AA MSM的艾滋病毒发病率，这将与CHC相关 在美国各地。这项工作的长期目标是降低B/AA MSM中的艾滋病毒发病率， 与联邦终止艾滋病毒流行和国家艾滋病毒/艾滋病战略目标。这项申请由一名 经验丰富的研究人员团队，在以下领域开展HIV，PrEP和差异研究， 现实世界的临床环境。

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.