Choice-Based PrEP Delivery for Transgender People in Uganda

为乌干达跨性别者提供基于选择的 PrEP 服务

• 批准号: 10677722
• 负责人: Andrew Mujugira
• 金额: $ 47.85万
• 依托单位: INFECTIOUS DISEASES INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-05 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10677722
• 关键词: AIDS prevention; Address; Adherence; Adult; Adverse event; Africa; Africa South of the Sahara; African; Budgets; Caring; Client; Clinical; Communities; Cost Analysis; Data; Discrimination; Educational workshop; Elements; Enabling Factors; Epidemic; Evaluation; Focus Groups; Formulation; Fumarates; General Population; HIV; HIV Infections; HIV Seronegativity; HIV risk; Health system; Incidence; Injectable; Intervention; Interview; Learning; Literature; Mental Health; Methods; Modeling; Monitor; Oral; Outcome; Persons; Population; Predisposing Factor; Prevalence; Prevention; Provider; Qualitative Methods; Qualitative Research; Questionnaires; Reinforcing Factor; Research; Research Design; Risk; Sampling; Science; Service delivery model; Services; Site; Structure; Substance abuse problem; Tenofovir; Time; Uganda; Underrepresented Populations; aged; budget impact; cis-male; cohort; community consultation; community engagement; cost; cost estimate; design; empowerment; emtricitabine; experience; follow-up; high risk; implementation evaluation; implementation intervention; improved; interest; microcosting; model development; multidisciplinary; pill; pre-exposure prophylaxis; preference; preventive intervention; primary outcome; programs; prospective; public health intervention; response; service delivery; sex; social stigma; success; therapy design; therapy development; tool; transgender; transgender men; transgender women

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.

项目摘要/摘要 变性人（TGP）有艾滋病毒感染的高风险，并且是一个重要的，研究不足的钥匙 撒哈拉以南非洲的人口。在全球范围内，TGP的HIV获取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HIV预防工具，可以改变 TGP中艾滋病毒流行的轨迹，但由于缺乏，其种群水平的影响是次优的 获得准备，并且对每日药丸的依从性不佳。长效公式克服了一些 每日药丸的局限性预示着准备选项的新时代。 TGP的当前准备选择包括：1） 每天用富特诺哌维丁蛋白酶（FTC/TDF）或Tenofovir共同形成的Emtricitabine每日口服准备 Alafenamide（FTC/TAF）和2）可注射的长表演Cabotegravir（Cab La）。 Cab La是一个紧急的 TGP有效预防艾滋病毒的干预措施，他们可能无法始终遵守每日药，口服 对于可能不容忍CAB LA的用户来说，PREP是一种有效的预防选择。基于选择的准备交付是 预防艾滋病毒的“下一步”。选择准备配方（口服或注射准备）和选择 交付方法（社区或设施交付）可以带来预防艾滋病毒的重大进步，但也没有 在非洲为TGP实施。针对TGP的基于选择的PREP交付的杰出问题包括End- 用户偏好，如何提供可注射的准备，了解选择科学以及准备轨迹 在撒哈拉以南非洲的背景下进行选择。为了解决这些问题，我们将使用先前的问题 干预开发模型广泛用于公共卫生干预措施，设计，实施和 评估TGP的基于选择的准备交付。利用我们研究团队的多学科专业知识， 并在乌干达的TGP预防交付的三个地点工作，我们建议以下 具体目的：先前-1）确定通过使用影响跨性别者的准备的因素 定性方法，以识别影响预备实施的诱发，启用和增强因素 （干预设计）；继续-2）使用差异化的服务交付原则提供驾驶室LA的选择 口头准备，以及设施或社区交付的选择（可以切换或停止）到300 HIV阴性 TGP随访24个月，评估实施以及对准备的影响（干预） 执行）; 3）使用混合方法评估“如何”和“为什么”选择会影响TGP的准备使用 （干预评估）； 4）估计与将CAB LA集成到艾滋病毒相关的成本影响 计划（预算影响分析）。主要结果是准备公式的选择，依从性和 持久性和交付方法的选择。我们社区订婚的方法进行基于选择的准备交付 TGP之间的实施将揭示关键的程序化设计元素，以实现最佳依从性 艾滋病毒风险最高的艾滋病毒负担最高的艾滋病毒风险最高的人群的持久性。