Formative work to develop differentiated communication tools to facilitate transgender women's recruitment, enrollment, and retention in HIV vaccine trials

开发差异化沟通工具的形成性工作，以促进跨性别女性在艾滋病毒疫苗试验中的招募、登记和保留

• 批准号: 10620450
• 负责人: Christine Tagliaferri Rael
• 金额: $ 26.11万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-10 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10620450
• 关键词: AIDS prevention; Address; Adherence; Agreement; Anti-Retroviral Agents; Blood; Clinical; Collaborations; Communication; Communication Tools; Communities; Companions; Comprehension; Data; Databases; Development; Discrimination; Enrollment; Ensure; Evaluation; FDA approved; Face; Funding; Future; HIV; HIV Vaccine Trials Network; HIV vaccine; Human immunodeficiency virus test; Image; Immunity; Incidence; Information Specialists; Injections; Institution; Intervention; Interview; Investments; Knowledge; Literature; Modeling; Names; New York; Nucleic Acids; Oral; Participant; Persons; Pharmaceutical Preparations; Phase; Population; Prevalence; Prevention strategy; Process; Reaction; Registries; Reporting; Research; Safety; Signal Transduction; Site; Specialist; System; Testing; United States; Universities; Vaccines; Viral Vector; Visit; Work; data quality; design; digital communication; digital health; digital tool; experience; flexibility; handheld mobile device; health care availability; health information technology; improved; medication compliance; mobile computing; operation; phase 1 study; phase I trial; pilot test; pre-exposure prophylaxis; preference; prototype; recruit; response; safety assessment; safety testing; social; social culture; social stigma; success; tool; transgender; transgender women; transphobia; uptake; usability; vaccine candidate; vaccine trial; virtual; willingness

ABSTRACT In the United States (US), HIV prevalence among transgender women (TW) is high (~14%). Yet, uptake of HIV pre-exposure prophylaxis (PrEP) among TW is low (5-20% of US TW report ever using PrEP) and adherence is often poor. This is in large part because TW were poorly represented in PrEP trials, leading to data quality issues, and gaps in knowledge about TW's experiences with PrEP. Our previous studies and other literature found that TW are unwilling to use biomedical HIV prevention strategies unless they have been tested for safety, tolerability, and efficacy with TW. HIV vaccines are a promising alternative or companion to PrEP, since vaccines would not require long-term, near-perfect adherence to a daily or bi-monthly product. However, it is currently impossible to evaluate HIV vaccine candidates for safety, tolerability, and efficacy among TW, since TW represent <2% of HIV vaccine trials participants. This dearth of data on TW is likely to limit, or preclude, the uptake of a future approved HIV vaccine in the population that may benefit the most from it. Further, given TW's sensitivity to data quantity/quality, it is likely that the lack of early trials data about them impedes their willingness to enroll in other HIV vaccine trials phases. Thus, to increase TW's participation across all phases of HIV vaccine trials, we must first focus on increasing their recruitment and enrollment in Phase 1 trials. Recruiting and enrolling more TW in Phase 1 will generate more meaningful safety data on this population, which can be used to promote TW's participation in subsequent phases. Unfortunately, TW face multiple social and structural barriers to HIV vaccine trials participation, including stigma, discrimination, and transphobia (among others), all of which require large sociocultural changes to address. However, our formative work found a lack of tailored communication is also a critical, and more proximal, barrier to HIV vaccine trials engagement. For example, current efforts do not provide sufficient information on topics of concern to TW, nor do they offer information in a way that resonates with them. To intervene on this, we propose “VaxCom” a digital health communication tool to facilitate recruitment and enrollment of TW in Phase 1 HIV vaccine trials. We hypothesize VaxCom will improve recruitment and enrollment of TW into Phase 1 HIV vaccine trials by supporting discussions between recruitment and enrollment (R&E) specialists and TW regarding HIV vaccine questions/concerns, Phase 1 trials participation, and by providing relevant associated information to TW in a meaningful and tailored way. To develop VaxCom, we will first elicit TW's and R&E specialists' information needs and preferences for VaxCom. We will then incorporate them into an initial prototype of VaxCom that we further develop/refine alongside TW and R&E specialists through an iterative participatory design process. The resulting prototype will be evaluated for feasibility, acceptability, usability, and potential for success via simulated recruitment and enrollment sessions. The final product of this R21 will be an alpha prototype of VaxCom, which will be ready for pilot-testing in a future, R34-funded RCT.

摘要 在美国，跨性别女性（TW）的艾滋病毒感染率很高（约14%）。然而，艾滋病毒的感染 TW中暴露前预防（PrEP）的比例较低（美国TW报告的5-20%曾使用过PrEP）， 往往是穷人。这在很大程度上是因为TW在PrEP试验中的代表性很差，导致数据质量问题， 以及TW在PrEP方面经验的知识差距。我们之前的研究和其他文献发现， TW不愿意使用生物医学HIV预防策略，除非它们已经过安全性，耐受性， 和TW的功效。HIV疫苗是PrEP的一种有前途的替代品或伴侣，因为疫苗不会 需要长期、近乎完美地坚持每日或每两个月一次的产品。然而，目前不可能 在TW中评估HIV候选疫苗的安全性、耐受性和有效性，因为TW占HIV的2%以下 疫苗试验参与者TW数据的缺乏可能会限制或排除未来批准的 此外，鉴于TW对数据的敏感性， 数量/质量，可能是缺乏早期试验数据，阻碍了他们参加其他研究的意愿。 艾滋病毒疫苗试验阶段。因此，为了增加TW在HIV疫苗试验各个阶段的参与，我们必须 首先要关注增加1期试验的招募和入组。招募和招募更多TW， 第1阶段将在该人群中产生更有意义的安全性数据，这些数据可用于促进TW 参与后续阶段。不幸的是，TW面临着艾滋病毒疫苗的多重社会和结构性障碍 试验参与，包括耻辱，歧视和跨性别恐惧症（等等），所有这些都需要大量的 社会文化的变化。然而，我们的形成性工作发现，缺乏量身定制的沟通也是一个问题。 这是艾滋病毒疫苗试验参与的一个关键和更近的障碍。例如，目前的努力没有提供 他们没有就TW关注的主题提供足够的信息，也没有以与他们产生共鸣的方式提供信息。 为了干预这一点，我们提出了“VaxCom”数字健康通信工具，以促进招聘， TW参与HIV疫苗1期试验。我们假设VaxCom将改善招募和注册 通过支持招募和入组（R&E）之间的讨论，将TW纳入1期HIV疫苗试验 专家和TW关于HIV疫苗问题/关注，1期试验参与，并通过提供 以有意义和定制的方式向TW提供相关的相关信息。为了发展VaxCom我们首先要引出 TW和R&E专家对VaxCom的信息需求和偏好。我们将把它们纳入 VaxCom的初始原型，我们与TW和R&E专家一起通过 迭代参与式设计过程。由此产生的原型将被评估的可行性，可接受性， 可用性和通过模拟招募和登记会议获得成功的潜力。最终的产品 R21将是VaxCom的alpha原型，它将在未来的R34资助的RCT中进行试点测试。