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: 10545791
• 负责人: Andrew Mujugira
• 金额: $ 51.98万
• 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/10545791
• 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; Lead; 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; base; budget impact; cisgender; cohort; community consultation; cost; cost estimate; design; 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; 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.

项目总结/摘要 跨性别者（TGP）是艾滋病毒感染的高危人群，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感染艾滋病毒的风险比其他成年人高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，可以改变 艾滋病毒在三峡工程中流行的轨迹，但由于缺乏 获得PrEP，以及对每日药丸的坚持性差。长效制剂，克服了一些 每日药丸的局限性预示着PrEP选择的新时代。目前TGP的PrEP选择包括：1） 每日口服PrEP，恩曲他滨与富马酸替诺福韦酯（FTC/TDF）或替诺福韦共同配制 艾拉酚胺（FTC/TAF），和2）可注射长效卡替拉韦（CAB LA）。CAB LA是一个紧急的， 有效的艾滋病毒预防干预TGP谁可能无法坚持每天服用药丸，口服 PrEP是可能不耐受CAB LA的用户的有效预防选择。基于选择的PrEP交付是一种 艾滋病毒预防的“下一步”充满希望。PrEP制剂的选择（口服或注射PrEP）和 提供方法（社区或设施提供）可以在艾滋病毒预防方面取得重大进展，但两者都没有 已在非洲实施TGP。为TGP提供基于选择的PrEP的突出问题包括： 用户偏好，如何提供可注射的PrEP，了解选择的科学以及PrEP的轨迹 在撒哈拉以南非洲的选择。为了解决这些问题，我们将使用PRECEDE-PROCEED 干预发展模式，广泛用于公共卫生干预，设计，实施， 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， 并在乌干达三个有预防三峡工程经验的地点工作，我们提出以下建议 具体目标：PRECEDE - 1）确定影响变性人PrEP实施的因素， 定性方法，以确定影响PrEP实施的诱发因素，促进因素和强化因素 （干预设计）; PROCEED - 2）使用差异化服务提供原则，提供CAB-LA选择 或口服PrEP，并选择设施或社区交付（可选择转换或停止），以300艾滋病毒阴性 TGP随访24个月，评估实施情况和对PrEP使用的影响（干预） 实施）; 3）使用混合方法评估“如何”和“为什么”选择影响TGP中PrEP的使用 （干预评估）; 4）估计与CABLA整合到HIV相关的成本影响 预算影响分析（Budget Impact Analysis）主要结局是PrEP制剂的选择、依从性和 坚持和选择交付方法。我们的社区参与方法，以选择为基础的PrEP交付 三峡工程的实施将揭示实现最佳遵守的关键方案设计要素 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持续存在。