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.

抽象的 在美国 (US)，跨性别女性 (TW) 的艾滋病毒感染率很高（约 14%）。 台湾地区暴露前预防 (PrEP) 的比例较低（美国台湾地区报告中 5-20% 曾使用过 PrEP），且依从性较低 这在很大程度上是因为 TW 在 PrEP 试验中代表性较差，导致数据质量问题， 我们之前的研究和其他文献发现，对 TW 的 PrEP 经验的了解存在差距。 台湾不愿意使用生物医学艾滋病毒预防策略，除非它们已经过安全性、耐受性、 TW 疫苗的有效性和有效性是 PrEP 的一种有前途的替代品或伴侣，因为疫苗不会。 需要长期、近乎完美地坚持每天或每两个月一次的产品，但目前这是不可能的。 评估 TW 候选 HIV 疫苗的安全性、耐受性和有效性，因为 TW 占 HIV 的比例低于 2% TW 数据的缺乏可能会限制或排除未来批准的疫苗的使用。 此外，鉴于 TW 对数据的敏感性，HIV 疫苗可能会从中受益最多。 数量/质量，缺乏有关他们的早期试验数据可能会阻碍他们参加其他项目的意愿 HIV 疫苗试验阶段因此，为了增加 TW 在 HIV 疫苗试验所有阶段的参与，我们必须 首先专注于增加第一阶段试验的招募和注册人数 招募和注册更多的台湾人。 第一阶段将生成有关该人群的更有意义的安全数据，可用于促进 TW 的发展 不幸的是，台湾在艾滋病毒疫苗方面面临多重社会和结构性障碍。 审判参与，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 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。 例如，目前的努力并未提供参与艾滋病毒疫苗试验的关键且更直接的障碍。 关于 TW 关注的主题提供了足够的信息，也没有以与他们产生共鸣的方式提供信息。 为了干预这一问题，我们提出了“VaxCom”数字健康沟通工具，以促进招募和 我们帮助 VaxCom 改善招募和注册情况。 通过支持招募和入组 (R&E) 之间的讨论，使台湾进入第一阶段 HIV 疫苗试验 专家和台湾人关于艾滋病毒疫苗问题/疑虑、第一阶段试验参与，并通过提供 以有意义且量身定制的方式向 TW 提供相关信息 为了开发 VaxCom，我们首先会引出。 然后，我们会将 TW 和 R&E 专家的信息需求和偏好纳入 VaxCom。 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将评估最终原型的可行性、可接受性、 可用性以及通过模拟招聘和注册会议获得成功的潜力。 R21 将是 VaxCom 的 alpha 原型，准备在未来的 R34 资助的 RCT 中进行试点测试。