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

摘要 在美国，艾滋病毒在变性人妇女中的流行率很高(约14%)。然而，艾滋病毒的感染 暴露前预防(PrEP)在TW中很低(美国TW报告曾使用PrEP的5%-20%)，依从性是 通常都很穷。这在很大程度上是因为TW在PrEP试验中的代表性较差，导致数据质量问题， 以及对TW的PrEP经验的了解不足。我们之前的研究和其他文献发现 TW不愿使用生物医学艾滋病毒预防策略，除非已对其安全性、耐受性、 以及雷公藤多苷的疗效。艾滋病毒疫苗是PrEP的一个有希望的替代品或伴侣，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。然而，目前还不可能 评估HIV疫苗候选在TW中的安全性、耐受性和有效性，因为TW占HIV的2% 疫苗试验参与者。缺乏关于TW的数据可能会限制或排除对未来批准的 艾滋病疫苗在人群中可能受益最大。此外，鉴于TW对数据的敏感性 数量/质量，很可能是缺乏关于他们的早期试验数据阻碍了他们登记参加其他 艾滋病毒疫苗试验阶段。因此，为了增加TW在艾滋病毒疫苗试验的所有阶段的参与，我们必须 第一个重点是增加他们在第一阶段试验中的招募和登记。招募和招收更多TW 第一阶段将生成关于这一人群的更有意义的安全数据，这些数据可用于推广TW 参与后续阶段。不幸的是，TW在接种艾滋病毒疫苗方面面临着多重社会和结构障碍 试验参与，包括污名、歧视和变性人恐惧症(等等)，所有这些都需要大量的 要解决的社会文化变化。然而，我们的成型工作发现，缺乏量身定做的沟通也是一种 艾滋病毒疫苗试验参与的关键和更接近的障碍。例如，目前的努力没有提供 关于TW关心的主题的足够信息，也没有以引起他们共鸣的方式提供信息。 为了对此进行干预，我们提出了一种数字健康沟通工具VaxCom，以促进招聘和 TW在HIV疫苗第一阶段试验中登记。我们假设VaxCom将改善招聘和注册 通过支持招募和登记(R&E)之间的讨论，将TW纳入第一阶段艾滋病毒疫苗试验 关于艾滋病毒疫苗问题/关注的专家和TW，参与第一阶段试验，并通过提供 以有意义和量身定做的方式向TW提供相关信息。要发展VaxCom，我们首先要引出 TW和R&E专家对VaxCom的信息需求和偏好。然后我们将把它们合并到 VaxCom的初始原型，我们与TW和研发专家一起通过 迭代参与式设计过程。将对生成的原型进行可行性、可接受性、 可用性，以及通过模拟招聘和注册会议取得成功的潜力。它的最终产品是 R21将是VaxCom的阿尔法原型，它将在未来准备进行中试，R34资助的RCT。

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.