Biomedical Prevention Adherence Dynamics in a High Priority Population

7.项目摘要 变性妇女（TW）受艾滋病毒的影响不成比例，发病率最高， 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 TW之间的感染;然而，在这一人群中缺乏关于PrEP的研究。数据紧急 需要考虑到独特的需求，关注，艾滋病毒风险行为模式和卫生保健利用动态 影响TW中PrEP的启动、持续性和依从性。此外，还需要更多的数据， TW中的依从行为和药物浓度，特别是在社区关注的背景下 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（DDI）， 使用TW。这项R21研究是基于科学前提，即目前研究文献中的空白限制了 TW中PrEP的有效利用，以及更好地了解PrEP的吸收，坚持和 TW的TFV水平对于制定最佳的HIV预防计划至关重要。该项目利用了 在一个以LGBT为重点的社区健康中心，现有的TW PrEP队列，为了更好地 了解并改善PrEP实施工作与这一人群。R21项目的具体目标 （1）确定与接触TW样本中PrEP启动和持续性相关的因素 （2）识别与目标相关的相关因素、激励因素和预测因素（即，TFV-DP水平） 以及服用PrEP至少三个月的TW队列中PrEP依从性的自我报告措施;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相关性 在为期6个月的PrEP中，为了实现这些目标，我们将开展两项互补性工作， 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， 选择启动PrEP的160名TW女性，以及在同一12个月期间拒绝PrEP的160名TW。 第二，我们将进行一项前瞻性队列研究，在这项研究中，我们将对两个队列的患者进行6- 个月：1）已接受PrEP至少3个月的TW（n = 100）;以及2）已获得 PrEP服务至少3个月，但拒绝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PrEP依从性的客观措施（即，测量TFV- DP浓度）、激素水平的测量和给药方式（例如，贴剂、片剂、注射剂）， 以及在入组、3个月和6个月随访时关于心理社会变量的自我报告调查数据。在 此外，我们将招募一个使用注射雌二醇的TW子样本，以检查TFV-DP和激素 谷浓度（即，注射访问）和峰值（即，4-注射后天数）水平，以确定任何潜在的 波动这项研究将是第一个探索PrEP的启动，持续性和大规模人群中的依从性的研究。 在一个真实的世界环境中的TW队列，并准备通过以下方式产生直接，重大和持续的影响： 确定干预措施所需的关键因素，以改善PrEP的实施并降低艾滋病毒的发病率。

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.