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

项目摘要 在美国，遏制艾滋病毒流行的努力受到了次优依从性的阻碍：只有63%的人 被诊断为艾滋病毒感染者的病毒受到抑制。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，导致他们的发病率，死亡率和艾滋病毒感染率增加， 传输因此，迫切需要优化妇女病毒抑制的战略。长效 注射（LAI）ART，每4周或8周肌肉注射一次，在阶段中不劣于口服ART 3项试验，有可能通过消除对每日药片的需求来改变艾滋病毒治疗。黎艺可 显著降低了女性的依从性障碍，但女性仅占试验参与者的8%-33%， 他们在LAI ART的经历尚未得到充分探讨。为了填补这一空白，我们的团队进行了 对感染艾滋病毒的妇女进行定性研究，探讨她们对LAI ART的兴趣和障碍， 促进其使用。我们的研究表明，为了使LAI ART充分发挥其潜力，我们必须： 最有可能坚持LAI ART的妇女，解决其使用的障碍，并支持共同决策 确保妇女及其提供者选择最有利于坚持治疗的艾滋病毒治疗方式 由于没有工具可以支持WLWH对口服与LAI HIV药物的共同决策，我们 建议进行混合方法研究，以开发基于网络的患者决策辅助工具，即ART+支持 （i）抗逆转录病毒疗法）。这个R34是由一个早期阶段的研究者和专家研究团队领导的， MACS/WIHS联合队列研究（MWCCS）中的合作。R34研究将包括MWCCS 提供者和WLWH（包括护理中和护理外），他们最终将在口服和LAI ART之间做出选择。 我们将通过对45家供应商的深入采访和1500家供应商的调查数据生成i.ARTs内容 妇女在妇女福利、社区服务和社区服务中心九个地点的工作。这将确定最有可能坚持LAI的女性的特征 抗逆转录病毒疗法、妇女使用抗逆转录病毒疗法的性别驱动因素以及支持坚持抗逆转录病毒疗法的解决方案。在目标2中 我们将与MWCCS供应商和WLWH一起组织五个焦点小组，以迭代方式开发i. ART 内容，评估和完善基于网络的i. ART版本。在目标3中，我们将用180 在佛罗里达州迈阿密的诊所进行WLWH，并比较i. ART组和对照组之间的结局（每组n=90）。 我们将评估i.辅助生殖技术的可行性、可用性和可接受性及其对妇女辅助生殖技术相关决策的影响 冲突，病毒抑制，门诊和药物补充。我们也会采访那些选择 来艺术探索“现实世界”的障碍使用。总之，该R34将开发和试点测试基于网络的患者 决策辅助工具，以促进WLWH及其提供商之间的共享决策，以帮助确定是否 口服或LAI ART最符合女性的偏好，并有助于她坚持ART。建议的R34 将开发一个患者决策辅助工具，以帮助确保LAI ART的全部潜力能够实现，因为它正在 因此，最大限度地发挥其能力，对艾滋病毒的流行产生重大和可持续的影响。

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.