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

提高男男性行为非裔美国男性准备持久性的干预措施

• 批准号: 10700346
• 负责人: Philip Andrew Chan
• 金额: $ 80.78万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10700346
• 关键词: Adherence; African American; Attention; Bisexual; Black race; Blood; Caring; Clinic; Clinical; Collaborations; Communication; Complex; Consensus; Continuity of Patient Care; Cost Analysis; Data; Disparity; District of Columbia; Effectiveness; Effectiveness of Interventions; Enrollment; Epidemic; Funding; Gays; Geography; Goals; HIV; HIV Infections; HIV/AIDS; Health Insurance; Incidence; Intervention; Measures; Methods; Mississippi; Modeling; Neighborhood Health Center; Not Hispanic or Latino; Oral; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacy facility; Pilot Projects; Population; Ramp; Randomized; Randomized, Controlled Trials; Recording of previous events; Research; Research Personnel; Rhode Island; Risk; Schedule; Services; Sex Orientation; Site; Telephone; Testing; Text Messaging; Time; Transportation; United States; United States National Institutes of Health; Visit; Washington; Work; black men who have sex with men; care outcomes; comparison control; cost; cost effective intervention; cost effectiveness; cost estimate; effectiveness evaluation; effectiveness testing; experience; health care service; high risk men; implementation study; improved; intervention cost; men who have sex with men; patient navigation; pre-exposure prophylaxis; prevent; primary outcome; programs; secondary analysis; social; social factors; social stigma; standard of care; structural determinants; treatment as usual

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.

项目概要 该 R01 申请建议进行一项全功效随机对照试验 (RCT) 来测试以下效果： 针对男男性行为者 (MSM) 的黑人/非裔美国人 (B/AA) 的患者导航干预 PrEP 的启动、坚持和保留护理。 B/AA 男男性行为者 (MSM) 是 美国艾滋病毒/艾滋病流行病的影响尤为严重。暴露前预防（PrEP）， 每日一次用药，可以显着降低感染艾滋病毒的风险。然而，社会和结构性障碍 导致 B/AA MSM 的 PrEP 启动、坚持和护理维持不理想。我们之前的 NIH 资助的试点研究（R34MH109371；MPI：Nunn、Chan、Mena）开发并评估了一项干预措施 在 PrEP (RAMP-IT-UP) 中保留并坚持 MSM，这是一个基于优势的简短患者导航计划 提高年轻 B/AA MSM 的 PrEP 护理结果。该干预措施被认为是高度可接受的 B/AA MSM 中并显示出初步效果。与对照组参与者相比， 从统计数据来看，RAMP-IT-UP 参与者更有可能根据药房开始 PrEP 并坚持 PrEP 填写数据和 PrEP 血液浓度。此外，RAMP-IT-UP 参与者更有可能保留在 PrEP 中 3 个月和 6 个月临床就诊时的护理。这项研究的具体目标#1将进行一次全功率 随机对照试验（RCT 评估 RAMP-IT-UP 在提高 PrEP 依从性方面的有效性 现实社区健康中心 (CHC) 中 B/AA MSM 的护理结果。具体目标#2 将评估参加 CHC 的 B/AA MSM 与标准相比 RAMP-IT-UP 的成本效益 的照顾。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 提高 B/AA MSM 的 PrEP 护理结果并降低 HIV 发病率，这与 CHC 相关 遍布美国。这项工作的长期目标是降低 B/AA MSM 中的艾滋病毒发病率，这与 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。该应用程序由 经验丰富的研究团队，在艾滋病毒、PrEP 和差异研究方面拥有良好的记录 真实世界的临床环境。