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.

项目概要/摘要 跨性别者（TGP）感染艾滋病毒的风险很高，是一个重要的、尚未得到充分研究的关键人群 在全球范围内，撒哈拉以南非洲地区的人口中，TGP 感染艾滋病毒的风险比其他成年人高 13 倍。 暴露前预防 (PrEP) 是一种有效的艾滋病毒预防工具，可以改变 15-49 岁的人群。 TGP 中艾滋病毒流行的轨迹，但由于缺乏 获得 PrEP 的机会，以及对每日服用药物的依从性差，但克服了一些问题的长效制剂。 每日服用药物的局限性预示着 PrEP 选择的新时代，目前 TGP 的 PrEP 选择包括：1) 每日口服 PrEP，使用恩曲他滨与富马酸替诺福韦二吡呋酯 (FTC/TDF) 或替诺福韦复合制剂 艾拉酚胺 (FTC/TAF) 和 2) 注射用长效卡博特韦 (CAB LA) 是一种新兴的药物。 对可能无法坚持每天服用药物和口服药物的 TGP 进行有效的 HIV 预防干预 对于不能耐受 CAB LA 的用户来说，PrEP 是一种有效的预防选择。 艾滋病毒预防的“下一步”有希望的 PrEP 制剂（口服或注射 PrEP）的选择和选择。 提供方法（社区或设施提供）可以为艾滋病毒预防带来重大进展，但两者都没有 已在非洲的 TGP 中实施，基于选择的 PrEP 交付的悬而未决的问题包括最终 - 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 为了解决这些问题，我们将使用 PRECEDE-PROCEED。 广泛应用于公共卫生干预措施的干预发展模型，旨在设计、实施和 利用我们研究团队的多学科专业知识评估基于选择的 PrEP 实施， 并在乌干达的三个具有 TGP 预防交付经验的地点工作，我们提出以下建议 具体目标： PRECEDE - 1) 通过使用以下方法确定影响跨性别者实施 PrEP 的因素： 定性方法来识别影响 PrEP 实施的诱发因素、促进因素和强化因素 （干预设计）；继续 - 2) 使用差异化服务提供原则提供 CAB-LA 的选择 或口服 PrEP，以及选择设施或社区交付（可选择切换或停止），至 300 名 HIV 阴性者 TGP 随访 24 个月，评估 PrEP 使用的实施情况和效果（干预 3) 使用混合方法评估选择“如何”和“为何”影响 TGP 中 PrEP 的使用 （干预评估）；和 4) 估计与将 CAB LA 纳入 HIV 相关的成本影响 计划（预算影响分析）的主要结果是 PrEP 配方选择、依从性和 我们的社区参与基于选择的 PrEP 交付方法。 TGP 中的实施和实施将揭示关键的程序设计元素，以实现最佳的遵守 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续存在。