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

补充：为跨性别女性使用长效生物医学艾滋病毒预防策略制定定制的实施和依从干预措施

• 批准号: 10594183
• 负责人: Christine Tagliaferri Rael
• 金额: $ 5.17万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10594183
• 关键词: AIDS prevention; Adherence; Behavior Therapy; Behavioral Sciences; Behavioral trial; Clinic; Clinical; Clinical Trials; Control Groups; Custom; Development; Effectiveness; Ensure; Future; Goals; HIV; HIV prevention trial; Home; Infrastructure; Injectable; Injections; Intervention; Interview; Left; Life; Mentored Research Scientist Development Award; Mentors; Methods; Mobile Health Application; Participant; Patient Preferences; Pharmaceutical Preparations; Pilot Projects; Prevention; Prevention Research; Prevention strategy; Process; Protocols documentation; Qualitative Methods; Randomized; Reading; Research; Research Activity; Research Personnel; Research Project Grants; Research Training; Risk; Role; Running; Testing; Training; United States National Institutes of Health; Vulnerable Populations; Walking; Woman; Work; base; demographics; design; experience; hands on research; high risk; improved; mHealth; medication compliance; meetings; pilot test; prevent; recruit; skills; smartphone Application; therapy development; tool; transgender; transgender women

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

拟议的 K01 奖为候选人提供实现其长期目标所需的技能 成为专注于跨性别女性的生物医学艾滋病毒预防领域的独立研究者 为此，候选人将提交一份 R01 来制定以 TW 为重点的策略，以提高对 然而，她必须完成以下任务：长效艾滋病毒预防产品（例如卡博特韦注射液）。 培训目标： 1) 在背景下获得依从性干预发展的形成性工作的培训 生物医学艾滋病毒预防试验，以支持长效产品的使用，2) 获得开发和试点的技能 测试移动医疗智能手机应用程序，以支持遵守长效生物医学艾滋病毒预防策略，3) 获得开发经验、运行和评估行为干预试验，以支持使用 生物医学产品，4) 积累在艾滋病毒预防研究背景下与 TW 合作的经验。 培训将扩大候选人整合行为科学和生物医学艾滋病毒预防的能力， 开发/测试结合参与者生活和工作的适当背景的依从性干预措施 与高危弱势群体 (TW) 合作，根据他们的需要提供艾滋病毒预防工具/干预措施，以提高他们的 长期有效性； NIH 的三个关键优先事项 为此，候选人将参加有指导的课程作业。 阅读、与导师的一对一会议、实践研究活动以及完成独立的研究 TW 面临与艾滋病毒预防药物依从性相关的独特挑战。 如果不加以解决，这些挑战将阻止 TW 获得有前景的长效艾滋病毒预防工具 在开发流程中，候选人将开发一个可复制的流程来定制这些工具的交付。 以及对 TW 需求的干预依从性（包括移动医疗应用程序），例如 惰性注射卡博特韦的工作建立在一项试点研究（PI：Rael）的基础上，以确定定制的交付方法。 台湾注射卡博特韦 候选人将使用定性方法（例如访谈、小组讨论）。 称为“设计会议”）设计依从性干预和移动医疗应用程序然后，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 （在家或无需预约的诊所注射）以提高依从性，而对照组的 TW 则将 参与基于 HPTN-083/084 的协议，这将作为未来 R01 的“概念验证”。 对此进行更大规模的测试，研究和培训将在 NYSPI/Columbia 附属机构进行，1) AFFIRM 项目，一项跨性别身份研究（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，一项生产长效形式的临床试验 卡博特韦（例如注射；UM1 AI120184；PI：SLAP-HIV 将提供临床监督（例如，确保）。 定制的交付策略是可行的）以及与临床试验结果相结合的机会。 K01 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。 项目总结/摘要第 6 页

项目成果

Conjoint Analysis of User Acceptability of Sustained Long-Acting Pre-Exposure Prophylaxis for HIV.

用户对 HIV 持续长效暴露前预防的可接受性联合分析。

• 发表时间: 2022-04
• 影响因子: 1.5
• 作者: Schieffer, Robert J;Bryndza Tfaily, Ewa;D'Aquila, Richard;Greene, George J;Carballo;Giguere, Rebecca;Tagliaferri Rael, Christine;Kiser, Patrick F;Hope, Thomas J
• 通讯作者: Hope, Thomas J