Supplement: Developing Tailored Delivery and Adherence Interventions for use of Long-Acting Biomedical HIV Prevention Strategies by Transgender Women

拟议的K01奖为候选人提供了实现她的长期目标所需的技能 成为生物医学艾滋病毒预防领域的独立研究员，专注于变性人妇女 (TW)。要做到这一点，候选人将提交一份R01，以制定以TW为重点的战略，以提高对 长效艾滋病毒预防产品(例如卡替格列韦注射剂)。然而，她必须完成以下工作 培训目标：1)在坚持干预发展的形成性工作中获得培训 生物医学艾滋病毒预防试验，以支持使用长效产品，2)获得开发和试点的技能 测试mHealth智能手机应用程序，以支持遵守长效生物医学艾滋病毒预防策略，3) 获得开发、运行和评估行为干预试验的经验，以支持 生物医药产品，以及4)在艾滋病毒预防研究的背景下与TW合作积累经验。 培训将扩大候选人将行为科学与生物医学艾滋病毒预防相结合的能力， 制定/测试遵从性干预措施，将参与者的生活和工作环境纳入其中 与高危弱势群体(TW)配合艾滋病毒预防工具/干预措施以满足他们的需求，以增加他们的 长期有效性；NIH的三个关键优先事项。为了做到这一点，考生将在指导下从事课程工作 阅读，与导师一对一的会议，动手研究活动，以及完成一个独立的 研究项目。TW面临着与艾滋病毒预防、用药依从性相关的独特挑战。左边 如果不加以解决，这些挑战将阻止TW获得有希望的长效艾滋病毒预防工具 在开发管道中。应聘者将开发一个可复制的流程来定制这些工具的交付 以及针对TW需求的遵守干预(将包括mHealth应用程序)，使用以下示例 惰性可注射卡波替格韦。工作建立在试点研究(PI：RAEL)的基础上，以确定要交付的定制方法 TW注射用卡波替格韦。应聘者将使用定性方法(例如面试、小组讨论 称为“设计会话”)来设计依从性干预和mHealth应用程序。然后，她将执行一个 部分随机的患者偏好试验，以确定TW是否能够使用定制的注射策略 (在家里或在无预约诊所注射)以提高依从性，而TW的对照组将 使用基于HPTN-083/084的协议。这将成为未来R01的“概念验证” 在更大的范围内进行测试。研究和培训将在NYSPI/Columbia进行，隶属于，1) 项目确认，变性人身份研究(R01HD079603；PI：Bockting)，将提供基础设施 用于关键研究活动(例如，招募)，以及2)SLAP-HIV，一种临床试验，以产生长效形式 卡替格列韦(例如，注射；UM1AI120184；PI：希望)。SLAP-HIV将提供临床监督(例如，确保 量身定制的给药策略是可行的)，并有机会与临床试验对接。研究成果 在K01期间获得的技能也适用于其他长效艾滋病毒预防工具和风险群体。 项目摘要/摘要第6页

The proposed K01 Award provides the candidate with the skills needed to achieve her long-term goal of becoming an independent investigator in the field of biomedical HIV prevention focused on transgender women (TW). To do this, the candidate will submit an R01 to develop TW-focused strategies to improve adherence to long-acting HIV prevention products (e.g., cabotegravir injections). However, she must accomplish following training goals: 1) obtain training in the formative work of adherence intervention development within the context of biomedical HIV prevention trials to support the use of long-acting products, 2) gain skills to develop and pilot test an mHealth smartphone app to support adherence to long-acting biomedical HIV prevention strategies, 3) gain experience developing, running, and evaluating trials of behavioral interventions to support the use of biomedical products, and 4) build experience working with TW within the context of HIV prevention research. Training will expand the candidate's ability to integrate behavioral science and biomedical HIV prevention, develop/test adherence interventions that incorporate the appropriate context of participants' lives, and work with a high-risk vulnerable group (TW) to fit HIV prevention tools/interventions to their needs to increase their long-term effectiveness; three key NIH priorities. To do this, the candidate will engage in coursework, directed readings, one-on-one meetings with mentors, hands-on research activities, and completion of an independent research project. TW have unique challenges related to HIV prevention medication adherence. Left unaddressed, these challenges will prevent TW from accessing the promising long-acting HIV prevention tools in the development pipeline. The candidate will develop a replicable process to tailor the delivery of these tools and an adherence intervention (that will include an mHealth app) to the needs of TW, using the example of inert injectable cabotegravir. Work builds on a pilot study (PI: Rael) to identify tailored methods to deliver injectable cabotegravir in TW. The candidate will use qualitative methods (e.g., interviews, group discussions called “Design Sessions”) to design the adherence intervention and the mHealth app. Then, she will execute a partially randomized patient-preference trial to determine if TW are able to use tailored injection strategies (injection at home or in walk-in clinics) to improve adherence, compared to a control group of TW who will engage a protocol based on HPTN-083/084. This will serve as a “proof of concept” for the future R01 that will test this on a larger scale. Research and training will take place at NYSPI/Columbia, in affiliation with, 1) Project AFFIRM, a study of transgender identity (R01HD079603; PI: Bockting), that will provide infrastructure for critical research activities (e.g., recruitment), and 2) SLAP-HIV, a clinical trial to produce a long-acting form of cabotegravir (e.g., injection; UM1 AI120184; PI: Hope). SLAP-HIV will provide clinical oversight (e.g., ensure tailored delivery strategies are feasible) and the opportunity to interface with a clinical trial. Research findings and skills obtained during the K01 are applicable to other long-acting HIV prevention tools and risk groups. Project Summary/Abstract Page 6