Choice-Based PrEP Delivery for Transgender People in Uganda

项目摘要/摘要 变性人(TGP)是感染艾滋病毒的高危人群，是一个重要的、研究不足的关键 撒哈拉以南非洲的人口。在全球范围内，TGP人群感染艾滋病毒的风险是其他成年人的13倍 年龄15-49岁。暴露前预防(PrEP)是一种有效的艾滋病毒预防工具，可能会改变 三峡工程中艾滋病毒流行的轨迹，但其对人口层面的影响由于缺乏 获得PrEP，以及对每日避孕药的依从性较差。长效配方，克服了一些 每日服药的局限性预示着PrEP选择的新时代即将到来。目前TGP的PrEP选择包括：1) 恩曲他滨与富马酸替诺福韦(FTC/TDF)或替诺福韦的联合制剂 丙氨酰胺(FTC/TAF)，以及2)注射用长效卡波替韦(CAB LA)。CAB LA是一辆紧急和 对可能不能坚持每日服药和口服的TGP患者进行有效的HIV预防干预 对于可能不耐受CAB LA的用户来说，PREP是一种有效的预防选择。基于选择的PrEP交付是一种 承诺在艾滋病毒预防方面迈出“下一步”。PrEP制剂(口服或注射PrEP)的选择和 提供方法(社区或设施提供)可以在艾滋病毒预防方面带来重大进展，但两者都没有 已在非洲的三峡工程中实施。基于选择的PrEP向TGP交付的未决问题包括 用户偏好、如何提供可注射PrEP、了解选择的科学以及PrEP的发展轨迹 在撒哈拉以南非洲的情况下的选择。为了解决这些问题，我们将使用前面的 广泛用于公共卫生干预的干预发展模式，设计、实施和 评估TGP基于选择的PrEP交付。利用我们研究团队的多学科专业知识， 并在乌干达三个具有三峡工程预防工作经验的地点工作，我们提出以下建议 具体目标：在此之前-1)确定影响跨性别者实施PrEP的因素 定性方法，以确定影响PrEP实施的诱因、促成因素和强化因素 (干预设计)；继续-2)使用差异化服务交付原则提供CAB-LA选择 或口服PrEP，以及选择设施或社区分娩(可选择切换或停止)，将300例HIV阴性 TGP，随访24个月，评估PrEP的实施和效果(干预 实施)；3)使用混合方法来评估“如何”和“为什么”选择在三峡工程中影响PrEP的使用 (干预评估)；以及4)估计将CAB LA整合到艾滋病毒中的成本影响 方案(预算影响分析)。主要结果是PrEP配方的选择、坚持和 坚持和选择交付方式。我们的社区参与了基于选择的PrEP交付方法 而三峡工程的实施将揭示实现最优遵守的关键方案设计元素 以及在艾滋病毒负担最重的大陆上艾滋病毒风险最高的人群中的持久性。

PROJECT SUMMARY/ABSTRACT Transgender people (TGP) are at high risk for HIV infection, and are an important, under-researched key population in sub-Saharan Africa. Globally, HIV acquisition risk among TGP is 13 times higher than other adults aged 15-49 years. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention tool that could change the trajectory of the HIV epidemic among TGP, yet its population-level impact has been suboptimal due to lack of access to PrEP, and poor adherence to a daily pill. Long-acting formulations that overcome some of the limitations of a daily pill herald a new era of choice in PrEP options. Current PrEP choices for TGP include: 1) daily oral PrEP with emtricitabine co-formulated with tenofovir disoproxil fumarate (FTC/TDF) or tenofovir alafenamide (FTC/TAF), and 2) injectable long acting cabotegravir (CAB LA). CAB LA is an emergent and effective HIV prevention intervention for TGP who may not be able to consistently adhere to a daily pill, and oral PrEP is an effective prevention option for users who may not tolerate CAB LA. Choice-based PrEP delivery is a promising “next step” in HIV prevention. Choice of PrEP formulation (oral or injectable PrEP) and choice of delivery approach (community or facility delivery) could bring a major advance in HIV prevention, but neither has been implemented for TGP in Africa. Outstanding questions for choice-based PrEP delivery to TGP include end- user preferences, how to deliver injectable PrEP, understanding the science of choice, and trajectories of PrEP choice in the context of sub-Saharan Africa. To address these questions, we will use the PRECEDE-PROCEED intervention development model that is widely used for public health interventions, to design, implement, and evaluate choice-based PrEP delivery for TGP. Leveraging the multi-disciplinary expertise of our research team, and working at three sites experienced in prevention delivery for TGP in Uganda, we propose the following specific aims: PRECEDE - 1) identify factors that influence PrEP implementation for transgender people by using qualitative methods to identify predisposing, enabling, and reinforcing factors that impact PrEP implementation (intervention design); PROCEED - 2) use differentiated service delivery principles to offer choice of CAB-LA or oral PrEP, and choice of facility or community delivery (with option to switch or stop), to 300 HIV-negative TGP with follow-up for 24 months and evaluate implementation and effect on PrEP use (intervention implementation); 3) use mixed methods to evaluate “how” and “why” choice influences PrEP use among TGP (intervention evaluation); and 4) estimate cost implications associated with integrating CAB LA into HIV programs (budget impact analysis). The primary outcomes are PrEP formulation choice, adherence and persistence and choice of delivery approach. Our community engaged approach to choice-based PrEP delivery and implementation among TGP will reveal key programmatic design elements to achieve optimal adherence and persistence among a population with the highest HIV risk on a continent with the highest HIV burden.