Biomedical Prevention Adherence Dynamics in a High Priority Population

7.项目总结 变性妇女(TW)不成比例地受到艾滋病毒的影响，并具有一些最高的发病率和 在美国和世界各地的流行率。PREP具有降低艾滋病毒感染率的巨大潜力 在TW人群中的感染；然而，在这一人群中关于PrEP的研究明显缺乏。数据非常紧急 需要关于独特的需求、关切、艾滋病毒风险行为模式和卫生保健利用动态 这影响了TW中PrEP的启动、持久性和坚持性。此外，还需要更多数据 TW中的遵守行为和药物浓度，特别是在社区关切的背景下 关于抗逆转录病毒药物和雌激素制剂之间的药物相互作用(DDiS) 由TW使用。这项R21研究是基于目前研究文献中的空白限制的科学前提 在TW中有效利用PrEP，并更好地了解PrEP的摄取、依从性和 TW的TFV水平对于制定最佳的艾滋病毒预防方案至关重要。该项目利用了 在一个以LGBT为重点的社区卫生中心，现有的TW关于PrEP的队列，以便更好地 了解并改进针对这一群体的PrEP实施工作。这个R21项目的具体目标是 目的是：(1)在具有访问权的TW样本中确定与PrEP启动和持续相关的因素 卫生保健；(2)确定与目标(即TFV-DP水平)相关的因素、激励因素和预测因素 以及在服用PrEP至少三个月的TW队列中自我报告遵守PrEP的措施；以及 (3)检查自我报告的依从性、TFV-DP浓度和雌二醇水平之间的关系 在6个月的PrEP上的TW中。为了实现这些目标，我们将进行两个相辅相成的工作 探索性研究。首先，我们将进行详细的回顾性病例/控制图回顾研究，比较 选择启动PrEP的160名TW妇女，以及在同一12个月期间拒绝PrEP的160名已婚TW。 第二，我们将进行前瞻性队列研究，在该研究中，我们将对两个队列的患者进行6- 月：1)服用PrEP至少3个月的TW(n=100)；以及2)TW有机会 准备服务至少3个月，但拒绝接受PrEP(n=50)。数据收集将包括医疗记录 审查、艾滋病毒/性传播感染检测、自我报告和遵守PrEP的客观措施(即TFV- DP浓度)、激素水平测量和给药方式(例如贴片、片剂、注射剂)， 以及在注册时、3个月和6个月随访时的心理社会变量的自我报告调查数据。在……里面 此外，我们将招募TW的亚样本，使用注射用雌二醇来检测TFV-DP和激素 低谷(即注射就诊)和高峰(即注射后4天)水平的浓度，以确定任何潜在的 波动。这项研究将是第一次探索PrEP的启动、持续和坚持在 在现实世界环境中的TW队列，并准备在以下方面产生直接、重大和持续的影响 确定必要的关键因素进行干预，以改善预防接种计划的执行情况，降低艾滋病毒发病率。

7. PROJECT SUMMARY Transgender women (TW) are disproportionately impacted by HIV and have some of the highest incidence and prevalence rates in the US and around the world. PrEP has tremendous potential to reduce rates of HIV infection among TW; however, there is a striking lack of research on PrEP in this population. Data are urgently needed regarding the unique needs, concerns, HIV risk behavior patterns and health care utilization dynamics that impact PrEP initiation, persistence, and adherence among TW. In addition, more data are needed on adherence behavior and drug concentrations among TW, especially in the context of community concerns about drug-drug interactions (DDIs) between antiretrovirals and the estrogen formulations most commonly used by TW. This R21 study is based on the scientific premise that current gaps in the research literature limit the effective utilization of PrEP among TW, and that a better understanding of PrEP uptake, adherence and TFV levels in TW is critical to the development of optimal HIV prevention programs. The project leverages an existing cohort of TW on PrEP at an LGBT-focused community-based health center, in order to better understand and improve PrEP implementation efforts with this population. The specific aims of this R21 project are to: (1) Identify factors associated with PrEP initiation and persistence among a sample of TW with access to health care; (2) Identify correlates, motivators, and predictors associated with objective (i.e., TFV-DP levels) and self-report measures of PrEP adherence among a cohort of TW taking PrEP for at least three months; and (3) Examine the association between self-reported adherence, TFV-DP concentrations, and estradiol levels among TW on PrEP over a 6-month period. To accomplish these aims, we will conduct two complementary exploratory studies. First, we will conduct a detailed retrospective case/control chart review study, comparing 160 TW women who chose to initiate PrEP to 160 yoked TW who refused PrEP in the same 12-month period. Second, we will conduct a prospective cohort study, in which we will follow two cohorts of patients for 6- months: 1) TW who have been on PrEP for at least 3 months (n = 100); and 2) TW who have had access to PrEP services for at least 3 months but have refused PrEP (n = 50). Data collection will include medical record review, HIV/STI testing, self-reported and objective measures of PrEP adherence (i.e., measurement of TFV- DP concentrations), measurement of hormone levels and mode of administration (e.g., patch, tabs, injectable), and self-report survey data on psychosocial variables at enrollment, 3-month, and 6-month follow-up. In addition, we will enroll a subsample of TW using injectable estradiol to examine TFV-DP and hormone concentrations at trough (i.e., injection visit) and peak (i.e., 4-days post injection) levels to identify any potential fluctuations. This study would be the first to explore PrEP initiation, persistence, and adherence among a large cohort of TW in a real world setting and is poised to have an immediate, significant and sustained impact by identifying critical factors necessary to intervention to improve PrEP implementation and reduce HIV incidence.