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

拟议的K 01奖为候选人提供了实现其长期目标所需的技能 成为一个独立的研究人员在生物医学艾滋病毒预防领域的重点是变性妇女 （TW）.为此，候选人将提交一份R 01，以制定以TW为重点的策略， 长效HIV预防产品（例如，卡替拉韦注射液）。但是，她必须做到以下几点： 培训目标：1）在背景下获得依从性干预发展的形成性工作培训 生物医学艾滋病毒预防试验，以支持使用长效产品，2）获得技能，开发和试点 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，以支持使用 生物医学产品，以及4）在艾滋病毒预防研究的背景下与TW合作积累经验。 培训将扩大候选人的能力，整合行为科学和生物医学艾滋病毒预防， 制定/测试依从性干预措施，纳入参与者生活和工作的适当背景 与高危弱势群体（TW）合作，使艾滋病毒预防工具/干预措施符合他们的需求， 长期有效性;三个关键NIH优先事项。要做到这一点，候选人将从事课程，指导 阅读，与导师一对一的会议，动手研究活动，并完成独立的 研究项目。TW在艾滋病毒预防药物依从性方面面临着独特的挑战。左 如果这些挑战得不到解决，TW将无法获得有希望的长效艾滋病毒预防工具 在发展管道中。候选人将开发一个可复制的流程，以定制这些工具的交付 以及针对TW需求的依从性干预（包括移动健康应用程序），例如 惰性注射用卡替拉韦。工作建立在试点研究（PI：Rael）的基础上，以确定有针对性的交付方法 TW注射用卡替拉韦。候选人将使用定性方法（例如，访谈、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 部分随机化患者偏好试验，以确定TW是否能够使用定制的注射策略 （在家里或在诊所注射），以提高依从性，与对照组的TW谁将 执行基于HPTN-083/084的协议这将作为未来R 01的“概念验证”， 在更大的范围内测试这个。研究和培训将在NYSPI/哥伦比亚大学进行，与以下机构有联系： AFFIRM项目，一项跨性别身份研究（R 01 HD 079603; PI：Bockting），将提供基础设施 对于关键的研究活动（例如，招募），以及2）SLAP-HIV，一项生产长效形式的临床试验 卡替拉韦（例如，注射; UM 1AI 120184; PI：Hope）。SLAP-HIV将提供临床监督（例如，确保 定制的递送策略是可行的）以及与临床试验对接的机会。研究成果 在K 01期间获得的知识和技能适用于其他长效艾滋病毒预防工具和风险群体。

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.