Optimizing HIV adherence by developing a shared decision support tool to facilitate women's choice between oral and LAI ART

项目摘要 美国遏制艾滋病毒流行的努力因遵守情况不佳而受阻：只有63%的人 被诊断为艾滋病病毒携带者被病毒抑制。女性对口服抗逆转录病毒治疗的依从性较低 (ART)和病毒抑制比男性更容易导致他们的发病率、死亡率和艾滋病毒的进一步增加 变速箱。因此，迫切需要制定战略，优化妇女的病毒抑制。长效 可注射(LAI)ART，每4或8周肌肉注射一次，在阶段不逊于口腔ART 3项试验，有可能通过消除对每日服药的需要来改变艾滋病毒的治疗。赖艺梅 显著降低了妇女的依从性障碍，但妇女仅占试验参与者的8%-33%， 他们与赖艺术的经历没有得到充分的探索。为了帮助填补这一空白，我们团队进行了形成性 对艾滋病病毒携带者(WLWH)进行定性研究，以探索她们对LAI艺术和障碍的兴趣 促进者对它的使用。我们的研究表明，要想充分发挥赖氏艺术的潜力，我们必须：识别 最有可能坚持莱氏艺术，解决使用障碍，并支持共同决策的女性 确保妇女和她的提供者选择最有利于坚持治疗的艾滋病毒治疗方式 敬艺术。由于没有工具来支持WLWH对口服与LAI艾滋病药物的共同决策，我们 建议进行一项混合方法研究，以开发基于Web的患者决策辅助工具，i.ART+Support (I.ARTS)。这款R34是由一位早期研究人员和专家研究团队领导的，他们有丰富的生产历史 MACS/WIHS联合队列研究(MWCCS)内的合作。R34研究将包括MWCCS 提供者和WLWH(无论是在护理中还是在护理之外)，他们最终将在口腔艺术和赖艺术之间做出选择。在目标1中 我们将通过对45家供应商的深入访谈和来自1,500家供应商的调查数据来生成i.ART内容 九个MWCCS网站上的女性。这将确定最有可能坚持赖的女性的特征 艺术，女性赖氏艺术使用的特定性别驱动因素和支持赖氏艺术坚持的解决方案。在AIM 2 我们将组织五个焦点小组，每个小组都有MWCCS提供商和WLWH，以迭代地开发iART 内容以及评估和改进基于网络的i.ARTS版本。在目标3中，我们将使用180测试iART WLWH在佛罗里达州迈阿密的一家诊所，比较iARTS组和对照组(n=90)的结果。 我们将评估I.ARTS的可行性、可用性和可接受性，以及它对女性艺术相关决策的影响 冲突、病毒抑制、诊所就诊和药物补充。我们还将采访那些选择 探索赖氏艺术在“现实世界”中的运用障碍。总而言之，这款R34将开发和试点测试一个基于网络的患者 决策辅助工具，帮助WLWH及其提供者之间共享决策，以帮助确定 口述艺术或赖氏艺术最符合女性的喜好，并有助于她对艺术的坚持。建议的R34 将开发一种患者决策辅助工具，以帮助确保LAI ART的全部潜力能够实现 因此，最大限度地提高其显著和可持续地影响艾滋病毒流行的能力。

PROJECT ABSTRACT Efforts to curb the HIV epidemic in the United States (US) are impeded by suboptimal adherence: only 63% of people diagnosed with HIV are virally suppressed. Women have lower adherence to oral antiretroviral therapy (ART) and viral suppression than men, contributing to their increased morbidity, mortality and onward HIV transmission. There is thus an urgent need for strategies to optimize women's viral suppression. Long-acting injectable (LAI) ART, an every 4 or 8 weeks intramuscular injection that was non-inferior to oral ART in Phase 3 trials, has the potential to transform HIV treatment by eliminating the need for daily pills. LAI ART may significantly reduce women's adherence barriers, but women constituted only 8%-33% of trial participants and their experiences with LAI ART are under-explored. To help fill this gap, our team conducted formative qualitative research with women living with HIV (WLWH) to explore their interest in LAI ART and barriers and facilitators to its use. Our research demonstrated that for LAI ART to reach its full potential we must: identify the women most likely to adhere to LAI ART, address barriers to its use, and support shared decision-making to ensure that a woman and her provider choose the HIV treatment modality that will best facilitate adherence to ART. Since no tools exist to support WLWH's shared decision-making of oral vs. LAI HIV medication, we propose to conduct a mixed-method study to develop a web-based patient decision aid, i.ART+support (i.ARTs). This R34 is led by an early-stage investigator and expert study team with a history of productive collaboration within the MACS/WIHS Combined Cohort Study (MWCCS). The R34 study will include MWCCS providers and WLWH (both in and out of care), who will eventually choose between oral and LAI ART. In Aim 1 we will generate i.ARTs content through in-depth interviews with 45 providers and survey data from 1,500 women across nine MWCCS sites. This will identify the characteristics of women most likely to adhere to LAI ART, gender-specific drivers of women's LAI ART use and solutions to support LAI ART adherence. In Aim 2 we will conduct five focus groups each with MWCCS providers and WLWH to iteratively develop i.ARTs content and assess and refine the web-based version of i.ARTs. In Aim 3 we will pilot test i.ARTs with 180 WLWH in a Miami, FL clinic and compare outcomes between the i.ARTs arm and control arm (n=90 in each). We will assess i.ARTs' feasibility, usability and acceptability and its impact on women's ART-related decisional conflict, viral suppression, clinic attendance and medication refills. We will also interview women who choose LAI ART to explore “real-world” barriers to use. In sum, this R34 will develop and pilot test a web-based patient decision aid to facilitate shared decision-making between WLWH and their provider to help identify whether oral or LAI ART best matches a woman's preferences and facilitates her ART adherence. The proposed R34 will develop a patient decision aid to help ensure that the full potential of LAI ART can be realized as it is being rolled out, and thus maximize its ability to significantly and sustainably impact the HIV epidemic.